Pain, PostoperativePhase 4NCT07855341
Low-Volume Pericapsular Nerve Group (PENG) Block With Dexamethasone vs Standard-Volume PENG Block After Total Hip Arthroplasty
A Phase 4 study testing Pericapsular nerve group (PENG) block, Bupivacaine and Dexamethasone in people with Pain, Postoperative and Muscle Weakness, run by Ain Shams University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to compare two regimens of the pericapsular nerve group (PENG) block, an ultrasound-guided injection of local anaesthetic targeting the nerves supplying the front of the hip joint, for postoperative pain relief and quadriceps muscle function in patients undergoing primary unilateral… Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Pain, Postoperative, Muscle Weakness, Arthroplasty, Replacement, Hip
- What is being tested?
- Pericapsular nerve group (PENG) block, Bupivacaine and Dexamethasone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Oct 2026to 14 Sep 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Physical status ASA I or II.
- Age 50-70 years.
- Patients scheduled for elective primary unilateral total hip arthroplasty under spinal anaesthesia.
- No sex predilection.
Who cannot join
- Patient refusal.
- Physical status ASA III or above.
- Contraindications to spinal anaesthesia (coagulopathy, local infection at injection site, raised intracranial pressure).
- Revision or bilateral total hip arthroplasty.
- Known allergy or hypersensitivity to study drugs (bupivacaine, dexamethasone) or to any component of the multimodal analgesic regimen (paracetamol, nalbuphine).
- Pre-existing neuromuscular disease, lower-limb motor deficit, or neuropathic pain syndrome.
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- Uncontrolled diabetes mellitus (HbA1c > 8% or fasting blood glucose > 180 mg/dL) or any contraindication to corticosteroids.
- Cognitive impairment precluding pain and motor assessment, or chronic opioid use.
- Body mass index greater than 40 kg/m2 precluding adequate ultrasound visualization.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University Hospitals (El Demerdash Hospital)
Cairo, Cairo Governorate, 00202
Mohamed F Morsi, M.B., B.Ch., M.Sc., +201116618163, MohamedMorsi@med.asu.edu.eg
About this study
Official title: Low-Volume PENG Block With Dexamethasone Versus Standard-Volume PENG Block for Postoperative Analgesia and Quadriceps Function After Total Hip Arthroplasty
The goal of this clinical trial is to compare two regimens of the pericapsular nerve group (PENG) block, an ultrasound-guided injection of local anaesthetic targeting the nerves supplying the front of the hip joint, for postoperative pain relief and quadriceps muscle function in patients undergoing primary unilateral total hip arthroplasty under spinal anaesthesia.
The PENG block was originally proposed as a motor-sparing technique. However, the standard 20 mL volume can spread to the femoral nerve and cause quadriceps weakness. Reducing the injected volume may limit this spread and better preserve quadriceps strength, but smaller volumes risk shorter analgesic duration. Adding dexamethasone to a low-volume injection may compensate for the reduced volume.
Read more
The main questions this trial aims to answer are:
- Does a low-volume PENG block (10 mL bupivacaine 0.25%) with 4 mg dexamethasone differ from a standard-volume PENG block (20 mL bupivacaine 0.25%) in the time to first rescue analgesia?
- Does it differ in the incidence and severity of quadriceps weakness on the operated side?
Researchers will compare:
- Group A (standard-volume PENG block): 20 mL bupivacaine 0.25%.
- Group B (low-volume PENG block with dexamethasone): 5 mL bupivacaine 0.5% plus 4 mL normal saline plus 4 mg dexamethasone in 1 mL, giving 10 mL of bupivacaine 0.25%.
Participants will:
- Receive spinal anaesthesia with heavy bupivacaine 0.5% and fentanyl.
- Be randomly allocated to Group A or Group B using computer-generated random numbers.
- Receive the PENG block under ultrasound guidance, performed by an anaesthesiologist expert in regional anaesthesia.
- Receive intravenous paracetamol 1 g every 8 hours, with intravenous nalbuphine 5 mg as rescue analgesia when the pain score (NRS) is 4 or more.
- Be assessed by an anaesthesiologist blinded to group allocation for pain scores at rest and on movement at 2, 6, 12 and 24 hours; quadriceps strength (MRC scale and straight leg raise) at 6, 12 and 24 hours compared with the preoperative baseline; total opioid consumption over the first 24 hours; and time to first ambulation within the first 24 hours.
The primary outcome is the time from completion of the PENG block to the first administration of rescue analgesia, recorded over the first 24 hours postoperatively. The study will be conducted at Ain Shams University Hospitals (El Demerdash Hospital) and will include 60 patients (30 per group), aged 50 to 70 years, ASA physical status I or II.
Read the detailed description
Background: Hip surgery is associated with moderate to severe postoperative pain that, if poorly controlled, delays mobilization, prolongs hospital stay, and increases complications in a frequently elderly population. Opioid-based analgesia is limited by dose-dependent adverse effects such as sedation, respiratory depression, nausea, vomiting, and constipation, particularly harmful in older patients. Peripheral nerve blocks provide effective analgesia, reduce opioid requirements, and are therefore central to enhanced recovery pathways after hip surgery.
The anterior hip capsule, the most densely innervated region of the joint, receives sensory articular branches from the femoral, obturator, and accessory obturator nerves. These arise cephalad to the inguinal ligament and are therefore not reliably captured by traditional infra-inguinal techniques such as the femoral nerve block or fascia iliaca compartment block.
The pericapsular nerve group (PENG) block was described in 2018 as an ultrasound-guided injection of local anaesthetic into the musculofascial plane between the psoas tendon and the iliopubic eminence, targeting these articular branches while theoretically sparing motor components. Meta-analyses of randomized trials confirm that the PENG block reduces postoperative opioid consumption and pain scores after hip surgery and facilitates positioning for neuraxial anaesthesia.
Despite being promoted as motor-sparing, the PENG block performed with the conventional 20 mL volume has been repeatedly associated with quadriceps weakness, reported in approximately 25% or more of patients, attributed to spread of local anaesthetic toward the femoral nerve proper within the fascia iliaca compartment. Cadaveric and imaging studies support a volume-dependent relationship: larger volumes increase femoral nerve staining, whereas smaller volumes reduce this risk. A cadaveric study estimated the maximum effective volume sparing the femoral nerve in 90% of specimens to be approximately 13.2 mL.
However, lowering the volume may shorten the duration of analgesia. Dexamethasone is among the most studied adjuvants for peripheral nerve blocks and can prolong analgesia of long-acting local anaesthetics while reducing postoperative nausea and vomiting; the analgesic benefit is largely achieved at a dose of approximately 4 mg.
A preliminary randomized trial reported that adding dexamethasone to ropivacaine for the PENG block prolonged postoperative analgesia compared with ropivacaine alone. The PENG block has also been shown to improve early functional recovery and reduce time to ambulation after hip arthroplasty. More recent work suggests that combining dexamethasone with a reduced local anaesthetic volume in PENG block can maintain analgesia while preserving quadriceps strength. However, the available evidence largely employs ropivacaine and time-to-first rescue as the principal endpoint; data on a bupivacaine-based low-volume regimen with dexamethasone, evaluated as a complete analgesic strategy, remain limited, which forms the rationale for the present study.
Aim: To compare the analgesic efficacy and quadriceps motor function of two PENG block regimens, a low-volume block (10 mL bupivacaine 0.25%) with 4 mg dexamethasone versus a standard-volume block (20 mL bupivacaine 0.25%), in patients undergoing primary unilateral total hip arthroplasty.
Study design and setting: Prospective, randomized, controlled clinical trial conducted at Ain Shams University Hospitals (El Demerdash Hospital). Study period: 1 year.
Randomization and blinding: Eligible patients who fulfil the inclusion criteria and consent to participate will be randomly allocated into two equal groups using computer-generated random numbers, such that patients with even numbers will be enrolled in Group A (standard-volume PENG block) and patients with odd numbers will be enrolled in Group B (low-volume PENG block with dexamethasone). The participants, the outcome assessors and the data analyst will be blinded to group allocation.
Study procedure:
- History, clinical examination, and routine investigations (complete blood count, prothrombin time, partial thromboplastin time, random blood glucose) will be performed for all patients.
- All patients will be fasting for 2 hours for clear fluids and 8 hours for heavy meals.
- Standard monitoring (electrocardiography, non-invasive blood pressure, peripheral oxygen saturation) will be applied in the operating room and baseline readings recorded.
- Under strict aseptic conditions, standard intrathecal anaesthesia will be administered using a 25-gauge spinal needle with 3-4 mL heavy bupivacaine 0.5% and 10-12.5 mcg fentanyl as additive.
- In the event of hypotension, ephedrine 5-15 mg will be administered by slow titration.
- Adequacy of spinal anaesthesia will be confirmed after 5 minutes by a cold sensation test and the modified Bromage scale; an adequate block will be considered if the sensory level is at or above the tenth thoracic dermatome (T10).
- Study syringes will be prepared as follows: Group A (standard-volume PENG): 20 mL of bupivacaine 0.25% (50 mg). Group B (low-volume PENG with dexamethasone): 5 mL of bupivacaine 0.5% (25 mg) plus 4 mL of normal saline plus 4 mg dexamethasone in 1 mL, giving a total injectate volume of 10 mL of bupivacaine 0.25%.
- An 80-100 mm, 22-gauge echogenic needle is advanced in-plane from lateral to medial into the plane between the psoas tendon and the iliopubic eminence, and the local anaesthetic is injected in increments after negative aspiration.
- Correct injectate spread deep to the psoas tendon will be confirmed sonographically; failure to achieve appropriate spread will be recorded as a block failure.
- Both blocks will be performed by an anaesthesiologist who is an expert in regional anaesthesia, under strict aseptic conditions and ultrasound guidance using a low-frequency curvilinear transducer (2-5 MHz; C60xp; SonoSite X-Porte; SonoSite Inc., Bothell, WA, USA).
- The total bupivacaine dose (intrathecal plus block) will be kept within the recommended maximum of 2 mg/kg; the dose will be verified against body weight for each patient before injection.
- All patients will receive the same multimodal analgesic regimen: intravenous paracetamol 1 g every 8 hours. Rescue analgesia will be intravenous nalbuphine 5 mg, administered slowly when the Numerical Rating Scale (NRS) pain score is 4 or more.
- Intralipid emulsion 20% and full resuscitation facilities will be immediately available for management of local anaesthetic systemic toxicity.
- All postoperative pain and motor assessments will be performed by a single anaesthesiologist who is blinded to group allocation and who is not involved in randomization, block performance, or intraoperative care.
Primary outcome: Time to first rescue analgesia, defined as the interval (in hours) from completion of the PENG block to the first administration of rescue analgesia (NRS 4 or more), recorded over the first 24 hours postoperatively.
Secondary outcomes:
- Incidence and severity of quadriceps weakness on the operated side, assessed using the Medical Research Council (MRC) scale (0-5) together with the ability to perform a straight leg raise, at 6, 12 and 24 hours postoperatively compared with the preoperative baseline; clinically significant weakness defined as a reduction of one or more MRC grades or inability to perform a straight leg raise.
- Postoperative pain assessed using the NRS (0-10) at rest and on movement at 2, 6, 12 and 24 hours postoperatively.
- Total opioid consumption over the first 24 hours postoperatively.
- Time to first ambulation within the first 24 hours.
Sample size: Using the Power Analysis and Sample Size (PASS) 11 program, results from a previous randomized trial showed that the PENG plus dexamethasone group demonstrated a significantly longer time to first rescue opioid analgesia (15.0 +/- 1.5 hours vs 9.1 +/- 1.7 hours). Based on these findings, a sample size of 30 patients per group achieves 100% power to reject the null hypothesis of equal means when the population mean difference is 5.9 hours with standard deviations of 1.5 for group 1 and 1.7 for group 2, and with a significance level (alpha) of 0.05 using a two-sided two-sample unequal-variance t-test.
Statistical analysis: Data will be coded and analyzed using the Statistical Package for the Social Sciences (SPSS) version 23. The primary outcome (time to first rescue analgesia) will be analyzed using Kaplan-Meier survival analysis with the log-rank test, and a Cox proportional-hazards model will be used to estimate the hazard ratio with 95% confidence interval. Quantitative parametric data will be presented as mean +/- standard deviation (SD) and compared using the unpaired Student t-test; non-parametric data as median (interquartile range, IQR) using the Mann-Whitney test; and qualitative data as number and percentage using the chi-square or Fisher exact test. Repeated measurements over time (NRS, MRC) will be analyzed using a linear mixed-effects model. Analyses will follow both the intention-to-treat and per-protocol principles, with block failure and conversion to general anaesthesia handled as protocol deviations and reported. A p-value < 0.05 will be considered statistically significant.
Ethical considerations: The study will be conducted after approval from the Research Ethics Committee, Faculty of Medicine, Ain Shams University, and will be prospectively registered before enrolment of the first participant. Informed written consent will be obtained from all patients after a detailed explanation of the study procedure, including the off-label use of dexamethasone, the potential risks of the block (nerve injury, infection, local anaesthetic systemic toxicity), and the right to withdraw at any time without affecting their care. The privacy of participants and confidentiality of data will be guaranteed throughout all phases of the study.
- Being tested
- Pericapsular nerve group (PENG) block, Bupivacaine, Dexamethasone
- Keywords
- PENG block, Pericapsular Nerve Group Block, Dexamethasone, Bupivacaine, Quadriceps Strength, Total Hip Arthroplasty, Nerve Block
- Medical subject headings
- Pain, Postoperative, Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pericapsular nerve group (PENG) blockProcedure or surgery
Also called PENG block
An 80-100 mm, 22-gauge echogenic needle is advanced in-plane from lateral to medial into the plane between the psoas tendon and the iliopubic eminence under ultrasound guidance using a low-frequency curvilinear transducer (2-5 MHz), and the local anaesthetic is injected in increments after negative aspiration. Correct injectate spread deep to the psoas tendon will be confirmed sonographically.
BupivacaineDrug
Also called Marcaine
Group A: 20 mL of bupivacaine 0.25% (50 mg). Group B: 5 mL of bupivacaine 0.5% (25 mg) diluted to a total injectate volume of 10 mL of bupivacaine 0.25%. Injected as the PENG block.
DexamethasoneDrug
Also called Decadron
4 mg dexamethasone in 1 mL added to the PENG block injectate in Group B (perineural).
| Study group | Role | What they receive |
|---|---|---|
| Group B: Low-Volume PENG Block With Dexamethasone | Experimental | Patients will receive an ultrasound-guided PENG block with 5 mL of bupivacaine 0.5% (25 mg) plus 4 mL of normal saline plus 4 mg dexamethasone in 1 mL, giving a total injectate volume of 10 mL of bupivacaine 0.25%, after spinal anaesthesia. Receives: Procedure: Pericapsular nerve group (PENG) block; Drug: Bupivacaine; Drug: Dexamethasone |
| Group A: Standard-Volume PENG Block | Active comparator | Patients will receive an ultrasound-guided PENG block with 20 mL of bupivacaine 0.25% (50 mg) after spinal anaesthesia. Receives: Procedure: Pericapsular nerve group (PENG) block; Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to First Rescue Analgesia
The interval (in hours) from completion of the PENG block to the first administration of rescue analgesia (intravenous nalbuphine 5 mg, given when the Numerical Rating Scale pain score is 4 or more on a 0-10 scale, where 0 = no pain and 10 = worst possible pain).
Measured: From completion of the PENG block up to 24 hours postoperatively
Secondary outcomes (3)
Incidence and Severity of Quadriceps Weakness
Quadriceps strength on the operated side assessed using the Medical Research Council (MRC) scale (0-5, where 0 = no contraction and 5 = normal power) together with the ability to perform a straight leg raise, compared with the preoperative baseline. Clinically significant weakness is defined as a reduction of one or more MRC grades or inability to perform a straight leg raise.
Measured: Preoperative baseline and at 6, 12 and 24 hours postoperatively
Total Opioid Consumption
Total dose (mg) of rescue intravenous nalbuphine administered over the first 24 hours postoperatively.
Measured: First 24 hours postoperatively
Time to First Ambulation
Time (in hours) to first ambulation.
Measured: Within the first 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start15 Oct 2026
- Primary completion31 Aug 2027 (estimated)
- Study completion14 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomly allocated into two equal parallel groups: Group A (standard-volume PENG block: 20 mL bupivacaine 0.25%) and Group B (low-volume PENG block with dexamethasone: 10 mL bupivacaine 0.25% with 4 mg dexamethasone).
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Farag Mohamed Morsi, Ain Shams University
- Investigators
- Mohamed F Morsi, M.B., B.Ch., M.Sc., Principal investigator, Faculty of Medicine, Ain Shams UniversityAzza A AbdelAleem, MD, Study director, Faculty of Medicine, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07855341
- Sponsor's protocol ID
- FMASU MD232/2026
- Status last verified
- Oct 2026
- First submitted
- 28 Sep 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the published results will be made available upon reasonable request to the principal investigator.
Publications
Yu L, Shen X, Liu H. The efficacy of pericapsular nerve group block for postoperative analgesia in patients undergoing hip surgery: A systematic review and meta-analysis of randomized controlled trials. Front Med (Lausanne). 2023 Feb 24;10:1084532. doi: 10.3389/fmed.2023.1084532. eCollection 2023.
PubMed 36910500Aliste J, Layera S, Bravo D, Jara A, Munoz G, Barrientos C, Wulf R, Branez J, Finlayson RJ, Tran Q. Randomized comparison between pericapsular nerve group (PENG) block and suprainguinal fascia iliaca block for total hip arthroplasty. Reg Anesth Pain Med. 2021 Oct;46(10):874-878. doi: 10.1136/rapm-2021-102997. Epub 2021 Jul 20.
PubMed 34290085Balasubramaniam A, Kumar Naggaih S, Tarigonda S, Madhusudhana R. Ultrasound-Guided Pericapsular Nerve Group Block for Hip Surgery: A Randomized Controlled Trial Study Comparing Ropivacaine and Ropivacaine With Dexamethasone. Cureus. 2023 Jan 27;15(1):e34261. doi: 10.7759/cureus.34261. eCollection 2023 Jan.
PubMed 36855475Reysner T, Kowalski G, Mularski A, Pyszczorska M, Grochowicka M, Perek A, Daroszewski P, Reysner M. Perineural dexamethasone effectively prolongs anaesthesic block duration in total hip arthroplasty, reduces opioid consumption, and does not compromise motor function, nerve integrity, or glycaemic control. Int Orthop. 2025 Aug;49(8):1791-1799. doi: 10.1007/s00264-025-06578-1. Epub 2025 Jun 11.
PubMed 40498110Reysner T, Neumann-Podczaska A, Pietraszek P, Mularski A, Kowalski G, Daroszewski P, Reysner M. Reduced Ropivacaine Volume with Perineural Dexamethasone in PENG Block for Total Hip Arthroplasty: A Randomized Controlled Trial. J Clin Med. 2025 Dec 9;14(24):8722. doi: 10.3390/jcm14248722.
PubMed 41464623Zufferey PJ, Chaux R, Lachaud PA, Capdevila X, Lanoiselee J, Ollier E. Dose-response relationships of intravenous and perineural dexamethasone as adjuvants to peripheral nerve blocks: a systematic review and model-based network meta-analysis. Br J Anaesth. 2024 May;132(5):1122-1132. doi: 10.1016/j.bja.2023.12.021. Epub 2024 Jan 27.
PubMed 38281844Kim JY, Kim J, Kim DH, Han DW, Kim SH, Kim D, Chung S, Yu S, Lee UY, Park HJ. Anatomical and Radiological Assessments of Injectate Spread Stratified by the Volume of the Pericapsular Nerve Group Block. Anesth Analg. 2023 Mar 1;136(3):597-604. doi: 10.1213/ANE.0000000000006364. Epub 2023 Feb 17.
PubMed 36727847Leurcharusmee P, Kantakam P, Intasuwan P, Malatong Y, Maikong N, Navic P, Kitcharanant N, Mahakkanukrauh P, Tran Q. Cadaveric study investigating the femoral nerve-sparing volume for pericapsular nerve group (PENG) block. Reg Anesth Pain Med. 2023 Nov;48(11):549-552. doi: 10.1136/rapm-2023-104419. Epub 2023 Apr 7.
PubMed 37028817Yeoh SR, Chou Y, Chan SM, Hou JD, Lin JA. Pericapsular Nerve Group Block and Iliopsoas Plane Block: A Scoping Review of Quadriceps Weakness after Two Proclaimed Motor-Sparing Hip Blocks. Healthcare (Basel). 2022 Aug 18;10(8):1565. doi: 10.3390/healthcare10081565.
PubMed 36011222Giron-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular Nerve Group (PENG) Block for Hip Fracture. Reg Anesth Pain Med. 2018 Nov;43(8):859-863. doi: 10.1097/AAP.0000000000000847.
PubMed 30063657
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-Volume PENG Block With Dexamethasone Versus Standard-Volume PENG Block for Postoperative Analgesia and Quadriceps Function After Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT07855341
- Acronym / sponsor ID
- FMASU MD232/2026
- Keywords
- PENG block, Pericapsular Nerve Group Block, Dexamethasone, Bupivacaine, Quadriceps Strength, Total Hip Arthroplasty, Nerve Block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Oct 2026 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 14 Sep 2027 (estimated)
- First posted
- 2 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to compare two regimens of the pericapsular nerve group (PENG) block, an ultrasound-guided injection of local anaesthetic targeting the nerves supplying the front of the hip joint, for postoperative pain relief and quadriceps muscle function in patients undergoing primary unilateral total hip arthroplasty under spinal anaesthesia.
The PENG block was originally proposed as a motor-sparing technique. However, the standard 20 mL volume can spread to the femoral nerve and cause quadriceps weakness. Reducing the injected volume may limit this spread and better preserve quadriceps strength, but smaller volumes risk shorter analgesic duration. Adding dexamethasone to a low-volume injection may compensate for the reduced volume.
The main questions this trial aims to answer are:
- Does a low-volume PENG block (10 mL bupivacaine 0.25%) with 4 mg dexamethasone differ from a standard-volume PENG block (20 mL bupivacaine 0.25%) in the time to first rescue analgesia?
- Does it differ in the incidence and severity of quadriceps weakness on the operated side?
Researchers will compare:
- Group A (standard-volume PENG block): 20 mL bupivacaine 0.25%.
- Group B (low-volume PENG block with dexamethasone): 5 mL bupivacaine 0.5% plus 4 mL normal saline plus 4 mg dexamethasone in 1 mL, giving 10 mL of bupivacaine 0.25%.
Participants will:
- Receive spinal anaesthesia with heavy bupivacaine 0.5% and fentanyl.
- Be randomly allocated to Group A or Group B using computer-generated random numbers.
- Receive the PENG block under ultrasound guidance, performed by an anaesthesiologist expert in regional anaesthesia.
- Receive intravenous paracetamol 1 g every 8 hours, with intravenous nalbuphine 5 mg as rescue analgesia when the pain score (NRS) is 4 or more.
- Be assessed by an anaesthesiologist blinded to group allocation for pain scores at rest and on movement at 2, 6, 12 and 24 hours; quadriceps strength (MRC scale and straight leg raise) at 6, 12 and 24 hours compared with the preoperative baseline; total opioid consumption over the first 24 hours; and time to first ambulation within the first 24 hours.
The primary outcome is the time from completion of the PENG block to the first administration of rescue analgesia, recorded over the first 24 hours postoperatively. The study will be conducted at Ain Shams University Hospitals (El Demerdash Hospital) and will include 60 patients (30 per group), aged 50 to 70 years, ASA physical status I or II.
Detailed description
Background: Hip surgery is associated with moderate to severe postoperative pain that, if poorly controlled, delays mobilization, prolongs hospital stay, and increases complications in a frequently elderly population. Opioid-based analgesia is limited by dose-dependent adverse effects such as sedation, respiratory depression, nausea, vomiting, and constipation, particularly harmful in older patients. Peripheral nerve blocks provide effective analgesia, reduce opioid requirements, and are therefore central to enhanced recovery pathways after hip surgery.
The anterior hip capsule, the most densely innervated region of the joint, receives sensory articular branches from the femoral, obturator, and accessory obturator nerves. These arise cephalad to the inguinal ligament and are therefore not reliably captured by traditional infra-inguinal techniques such as the femoral nerve block or fascia iliaca compartment block.
The pericapsular nerve group (PENG) block was described in 2018 as an ultrasound-guided injection of local anaesthetic into the musculofascial plane between the psoas tendon and the iliopubic eminence, targeting these articular branches while theoretically sparing motor components. Meta-analyses of randomized trials confirm that the PENG block reduces postoperative opioid consumption and pain scores after hip surgery and facilitates positioning for neuraxial anaesthesia.
Despite being promoted as motor-sparing, the PENG block performed with the conventional 20 mL volume has been repeatedly associated with quadriceps weakness, reported in approximately 25% or more of patients, attributed to spread of local anaesthetic toward the femoral nerve proper within the fascia iliaca compartment. Cadaveric and imaging studies support a volume-dependent relationship: larger volumes increase femoral nerve staining, whereas smaller volumes reduce this risk. A cadaveric study estimated the maximum effective volume sparing the femoral nerve in 90% of specimens to be approximately 13.2 mL.
However, lowering the volume may shorten the duration of analgesia. Dexamethasone is among the most studied adjuvants for peripheral nerve blocks and can prolong analgesia of long-acting local anaesthetics while reducing postoperative nausea and vomiting; the analgesic benefit is largely achieved at a dose of approximately 4 mg.
A preliminary randomized trial reported that adding dexamethasone to ropivacaine for the PENG block prolonged postoperative analgesia compared with ropivacaine alone. The PENG block has also been shown to improve early functional recovery and reduce time to ambulation after hip arthroplasty. More recent work suggests that combining dexamethasone with a reduced local anaesthetic volume in PENG block can maintain analgesia while preserving quadriceps strength. However, the available evidence largely employs ropivacaine and time-to-first rescue as the principal endpoint; data on a bupivacaine-based low-volume regimen with dexamethasone, evaluated as a complete analgesic strategy, remain limited, which forms the rationale for the present study.
Aim: To compare the analgesic efficacy and quadriceps motor function of two PENG block regimens, a low-volume block (10 mL bupivacaine 0.25%) with 4 mg dexamethasone versus a standard-volume block (20 mL bupivacaine 0.25%), in patients undergoing primary unilateral total hip arthroplasty.
Study design and setting: Prospective, randomized, controlled clinical trial conducted at Ain Shams University Hospitals (El Demerdash Hospital). Study period: 1 year.
Randomization and blinding: Eligible patients who fulfil the inclusion criteria and consent to participate will be randomly allocated into two equal groups using computer-generated random numbers, such that patients with even numbers will be enrolled in Group A (standard-volume PENG block) and patients with odd numbers will be enrolled in Group B (low-volume PENG block with dexamethasone). The participants, the outcome assessors and the data analyst will be blinded to group allocation.
Study procedure:
- History, clinical examination, and routine investigations (complete blood count, prothrombin time, partial thromboplastin time, random blood glucose) will be performed for all patients.
- All patients will be fasting for 2 hours for clear fluids and 8 hours for heavy meals.
- Standard monitoring (electrocardiography, non-invasive blood pressure, peripheral oxygen saturation) will be applied in the operating room and baseline readings recorded.
- Under strict aseptic conditions, standard intrathecal anaesthesia will be administered using a 25-gauge spinal needle with 3-4 mL heavy bupivacaine 0.5% and 10-12.5 mcg fentanyl as additive.
- In the event of hypotension, ephedrine 5-15 mg will be administered by slow titration.
- Adequacy of spinal anaesthesia will be confirmed after 5 minutes by a cold sensation test and the modified Bromage scale; an adequate block will be considered if the sensory level is at or above the tenth thoracic dermatome (T10).
- Study syringes will be prepared as follows: Group A (standard-volume PENG): 20 mL of bupivacaine 0.25% (50 mg). Group B (low-volume PENG with dexamethasone): 5 mL of bupivacaine 0.5% (25 mg) plus 4 mL of normal saline plus 4 mg dexamethasone in 1 mL, giving a total injectate volume of 10 mL of bupivacaine 0.25%.
- An 80-100 mm, 22-gauge echogenic needle is advanced in-plane from lateral to medial into the plane between the psoas tendon and the iliopubic eminence, and the local anaesthetic is injected in increments after negative aspiration.
- Correct injectate spread deep to the psoas tendon will be confirmed sonographically; failure to achieve appropriate spread will be recorded as a block failure.
- Both blocks will be performed by an anaesthesiologist who is an expert in regional anaesthesia, under strict aseptic conditions and ultrasound guidance using a low-frequency curvilinear transducer (2-5 MHz; C60xp; SonoSite X-Porte; SonoSite Inc., Bothell, WA, USA).
- The total bupivacaine dose (intrathecal plus block) will be kept within the recommended maximum of 2 mg/kg; the dose will be verified against body weight for each patient before injection.
- All patients will receive the same multimodal analgesic regimen: intravenous paracetamol 1 g every 8 hours. Rescue analgesia will be intravenous nalbuphine 5 mg, administered slowly when the Numerical Rating Scale (NRS) pain score is 4 or more.
- Intralipid emulsion 20% and full resuscitation facilities will be immediately available for management of local anaesthetic systemic toxicity.
- All postoperative pain and motor assessments will be performed by a single anaesthesiologist who is blinded to group allocation and who is not involved in randomization, block performance, or intraoperative care.
Primary outcome: Time to first rescue analgesia, defined as the interval (in hours) from completion of the PENG block to the first administration of rescue analgesia (NRS 4 or more), recorded over the first 24 hours postoperatively.
Secondary outcomes:
- Incidence and severity of quadriceps weakness on the operated side, assessed using the Medical Research Council (MRC) scale (0-5) together with the ability to perform a straight leg raise, at 6, 12 and 24 hours postoperatively compared with the preoperative baseline; clinically significant weakness defined as a reduction of one or more MRC grades or inability to perform a straight leg raise.
- Postoperative pain assessed using the NRS (0-10) at rest and on movement at 2, 6, 12 and 24 hours postoperatively.
- Total opioid consumption over the first 24 hours postoperatively.
- Time to first ambulation within the first 24 hours.
Sample size: Using the Power Analysis and Sample Size (PASS) 11 program, results from a previous randomized trial showed that the PENG plus dexamethasone group demonstrated a significantly longer time to first rescue opioid analgesia (15.0 +/- 1.5 hours vs 9.1 +/- 1.7 hours). Based on these findings, a sample size of 30 patients per group achieves 100% power to reject the null hypothesis of equal means when the population mean difference is 5.9 hours with standard deviations of 1.5 for group 1 and 1.7 for group 2, and with a significance level (alpha) of 0.05 using a two-sided two-sample unequal-variance t-test.
Statistical analysis: Data will be coded and analyzed using the Statistical Package for the Social Sciences (SPSS) version 23. The primary outcome (time to first rescue analgesia) will be analyzed using Kaplan-Meier survival analysis with the log-rank test, and a Cox proportional-hazards model will be used to estimate the hazard ratio with 95% confidence interval. Quantitative parametric data will be presented as mean +/- standard deviation (SD) and compared using the unpaired Student t-test; non-parametric data as median (interquartile range, IQR) using the Mann-Whitney test; and qualitative data as number and percentage using the chi-square or Fisher exact test. Repeated measurements over time (NRS, MRC) will be analyzed using a linear mixed-effects model. Analyses will follow both the intention-to-treat and per-protocol principles, with block failure and conversion to general anaesthesia handled as protocol deviations and reported. A p-value < 0.05 will be considered statistically significant.
Ethical considerations: The study will be conducted after approval from the Research Ethics Committee, Faculty of Medicine, Ain Shams University, and will be prospectively registered before enrolment of the first participant. Informed written consent will be obtained from all patients after a detailed explanation of the study procedure, including the off-label use of dexamethasone, the potential risks of the block (nerve injury, infection, local anaesthetic systemic toxicity), and the right to withdraw at any time without affecting their care. The privacy of participants and confidentiality of data will be guaranteed throughout all phases of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be randomly allocated into two equal parallel groups: Group A (standard-volume PENG block: 20 mL bupivacaine 0.25%) and Group B (low-volume PENG block with dexamethasone: 10 mL bupivacaine 0.25% with 4 mg dexamethasone).
| Arm | Type | Receives |
|---|---|---|
| Group B: Low-Volume PENG Block With Dexamethasone | Experimental | Procedure: Pericapsular nerve group (PENG) block, Drug: Bupivacaine, Drug: DexamethasonePatients will receive an ultrasound-guided PENG block with 5 mL of bupivacaine 0.5% (25 mg) plus 4 mL of normal saline plus 4 mg dexamethasone in 1 mL, giving a total injectate volume of 10 mL of bupivacaine 0.25%, after spinal anaesthesia. |
| Group A: Standard-Volume PENG Block | Active comparator | Procedure: Pericapsular nerve group (PENG) block, Drug: BupivacainePatients will receive an ultrasound-guided PENG block with 20 mL of bupivacaine 0.25% (50 mg) after spinal anaesthesia. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Physical status ASA I or II.
- Age 50-70 years.
- Patients scheduled for elective primary unilateral total hip arthroplasty under spinal anaesthesia.
- No sex predilection.
Key exclusion criteria (9 listed)
- Patient refusal.
- Physical status ASA III or above.
- Contraindications to spinal anaesthesia (coagulopathy, local infection at injection site, raised intracranial pressure).
- Revision or bilateral total hip arthroplasty.
- Known allergy or hypersensitivity to study drugs (bupivacaine, dexamethasone) or to any component of the multimodal analgesic regimen (paracetamol, nalbuphine).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pericapsular nerve group (PENG) blockAlso: PENG blockAn 80-100 mm, 22-gauge echogenic needle is advanced in-plane from lateral to medial into the plane between the psoas tendon and the iliopubic eminence under ultrasound guidance using a low-frequency curvilinear transducer (2-5 MHz), and the local anaesthetic is injected in increments after negative aspiration. Correct injectate spread deep to the psoas tendon will be confirmed sonographically. | Procedure or surgery | Group A: Standard-Volume PENG Block, Group B: Low-Volume PENG Block With Dexamethasone |
| BupivacaineAlso: MarcaineGroup A: 20 mL of bupivacaine 0.25% (50 mg). Group B: 5 mL of bupivacaine 0.5% (25 mg) diluted to a total injectate volume of 10 mL of bupivacaine 0.25%. Injected as the PENG block. | Drug | Group A: Standard-Volume PENG Block, Group B: Low-Volume PENG Block With Dexamethasone |
| DexamethasoneAlso: Decadron4 mg dexamethasone in 1 mL added to the PENG block injectate in Group B (perineural). | Drug | Group B: Low-Volume PENG Block With Dexamethasone |
Primary outcome
Time to First Rescue Analgesia
Time frame: From completion of the PENG block up to 24 hours postoperatively
The interval (in hours) from completion of the PENG block to the first administration of rescue analgesia (intravenous nalbuphine 5 mg, given when the Numerical Rating Scale pain score is 4 or more on a 0-10 scale, where 0 = no pain and 10 = worst possible pain).
3 secondary outcomes
Incidence and Severity of Quadriceps Weakness
Time frame: Preoperative baseline and at 6, 12 and 24 hours postoperatively
Total Opioid Consumption
Time frame: First 24 hours postoperatively
Time to First Ambulation
Time frame: Within the first 24 hours postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Background: PubMed 36910500Yu L, Shen X, Liu H. The efficacy of pericapsular nerve group block for postoperative analgesia in patients undergoing hip surgery: A systematic review and meta-analysis of randomized controlled trials. Front Med (Lausanne). 2023 Feb 24;10:1084532. doi: 10.3389/fmed.2023.1084532. eCollection 2023.
- Background: PubMed 34290085Aliste J, Layera S, Bravo D, Jara A, Munoz G, Barrientos C, Wulf R, Branez J, Finlayson RJ, Tran Q. Randomized comparison between pericapsular nerve group (PENG) block and suprainguinal fascia iliaca block for total hip arthroplasty. Reg Anesth Pain Med. 2021 Oct;46(10):874-878. doi: 10.1136/rapm-2021-102997. Epub 2021 Jul 20.
- Background: PubMed 36855475Balasubramaniam A, Kumar Naggaih S, Tarigonda S, Madhusudhana R. Ultrasound-Guided Pericapsular Nerve Group Block for Hip Surgery: A Randomized Controlled Trial Study Comparing Ropivacaine and Ropivacaine With Dexamethasone. Cureus. 2023 Jan 27;15(1):e34261. doi: 10.7759/cureus.34261. eCollection 2023 Jan.
- Background: PubMed 40498110Reysner T, Kowalski G, Mularski A, Pyszczorska M, Grochowicka M, Perek A, Daroszewski P, Reysner M. Perineural dexamethasone effectively prolongs anaesthesic block duration in total hip arthroplasty, reduces opioid consumption, and does not compromise motor function, nerve integrity, or glycaemic control. Int Orthop. 2025 Aug;49(8):1791-1799. doi: 10.1007/s00264-025-06578-1. Epub 2025 Jun 11.
- Background: PubMed 41464623Reysner T, Neumann-Podczaska A, Pietraszek P, Mularski A, Kowalski G, Daroszewski P, Reysner M. Reduced Ropivacaine Volume with Perineural Dexamethasone in PENG Block for Total Hip Arthroplasty: A Randomized Controlled Trial. J Clin Med. 2025 Dec 9;14(24):8722. doi: 10.3390/jcm14248722.
- Background: PubMed 38281844Zufferey PJ, Chaux R, Lachaud PA, Capdevila X, Lanoiselee J, Ollier E. Dose-response relationships of intravenous and perineural dexamethasone as adjuvants to peripheral nerve blocks: a systematic review and model-based network meta-analysis. Br J Anaesth. 2024 May;132(5):1122-1132. doi: 10.1016/j.bja.2023.12.021. Epub 2024 Jan 27.
- Background: PubMed 36727847Kim JY, Kim J, Kim DH, Han DW, Kim SH, Kim D, Chung S, Yu S, Lee UY, Park HJ. Anatomical and Radiological Assessments of Injectate Spread Stratified by the Volume of the Pericapsular Nerve Group Block. Anesth Analg. 2023 Mar 1;136(3):597-604. doi: 10.1213/ANE.0000000000006364. Epub 2023 Feb 17.
- Background: PubMed 37028817Leurcharusmee P, Kantakam P, Intasuwan P, Malatong Y, Maikong N, Navic P, Kitcharanant N, Mahakkanukrauh P, Tran Q. Cadaveric study investigating the femoral nerve-sparing volume for pericapsular nerve group (PENG) block. Reg Anesth Pain Med. 2023 Nov;48(11):549-552. doi: 10.1136/rapm-2023-104419. Epub 2023 Apr 7.
- Background: PubMed 36011222Yeoh SR, Chou Y, Chan SM, Hou JD, Lin JA. Pericapsular Nerve Group Block and Iliopsoas Plane Block: A Scoping Review of Quadriceps Weakness after Two Proclaimed Motor-Sparing Hip Blocks. Healthcare (Basel). 2022 Aug 18;10(8):1565. doi: 10.3390/healthcare10081565.
- Background: PubMed 30063657Giron-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular Nerve Group (PENG) Block for Hip Fracture. Reg Anesth Pain Med. 2018 Nov;43(8):859-863. doi: 10.1097/AAP.0000000000000847.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the published results will be made available upon reasonable request to the principal investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mohamed F Morsi, M.B., B.Ch., M.Sc. principal investigator
Faculty of Medicine, Ain Shams University
Azza A AbdelAleem, MD study director
Faculty of Medicine, Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pericapsular nerve group (PENG) block, Bupivacaine and Dexamethasone in people with Pain, Postoperative and Muscle Weakness, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed F Morsi, M.B., B.Ch., M.Sc. (+201116618163, MohamedMorsi@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to First Rescue Analgesia (time frame: From completion of the PENG block up to 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07855341, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.