Hip ArthroplastyNCT07442721
Sacral ESPB vs. PENG Block for Hip Hemiarthroplasty Analgesia
A study testing Sacral erector spinae plane block and PENG block in people with Hip Arthroplasty and Hip Fracture Surgeries, run by Fayoum University Hospital at 1 site in Egypt.
Trial summary
Sacral erector spinae plane block(S-ESPB) has been recently described. Case reports are showing that it is useful in various types of surgery. In case presentations, it has been reported as effective in providing analgesia in the posterior branches of the sacral nerves in pilonidal sinus surgery, in the treatment of… Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Hip Arthroplasty, Hip Fracture Surgeries, Femoral Neck Fractures
- What is being tested?
- Sacral erector spinae plane block and PENG block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2026to 1 Aug 2027
- Phase
- Interventional
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with ages from 50 to 90 years of either gender, with diagnosis of intracapsular neck of femur fracture scheduled for elective hip hemiarthroplasty • Patients with an American Society of Anesthesiologists (ASA) physical status I to III.
Who cannot join
- • Patient refusal.
- Allergy to local anesthetics and patient with infection at the injection site of block
- Patient with contraindication to spinal anesthesia.
- Coagulopathy as INR≥1.5 or platelets ≤80*103 / microliter)
- Patients with body mass index>35 kg / m2
- Patients with peripheral neuropathy or diabetic neuropathy
Show all 10Show fewer
- Patients receiving opioids for chronic analgesic therapy (cancer, addiction).
- Cognitive impairment preventing pain scoring.
- Chronic renal failure requiring dose modification.
- Bilateral hip fracture or previous ipsilateral hip surgery
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
Fayoum University hospita
El Fayoum Qesm, Faiyum Governorate, 63514
Mohamed Ahmed Hamed, MD, +20 10 10509736, mah07@fayoum.edu.eg
About this study
Official title: Sacral Erector Spinae Plane Block Versus Pericapsular Nerve Group Block For Analgesia In Hip Hemi Arthroplasty: A Randomized Comparative Study
Sacral erector spinae plane block(S-ESPB) has been recently described. Case reports are showing that it is useful in various types of surgery. In case presentations, it has been reported as effective in providing analgesia in the posterior branches of the sacral nerves in pilonidal sinus surgery, in the treatment of radicular pain at the L5 - S1 level, after a sex reassignment operation and hypospadias surgery, and its use in combination with lumbar ESPB for analgesia was reported after hip prosthesis surgery . Described in 2018, pericapsular nerve group (PENG) block selectively targets the articular branches of the femoral and accessory obturator nerves thereby providing potential motorsparing analgesia for hip surgery
. Recent studies found that PENG block targets the articular branches of the femoral and accessory obturator nerves, only anesthetizes the anterior hip joint sparing posterior part , as well as there was a motor impairment after block which is from local anesthetic (LA) diffusion to the femoral nerve
Read more
. Motor-sparing regional anesthesia techniques have emerged as a safer alternative, balancing effective pain relief with the preservation of quadriceps function . These techniques align with Enhanced Recovery After Surgery (ERAS) protocols, which emphasize multimodal pain control, opioid minimization, and early mobility to reduce complications such as venous thromboembolism (VTE) and postoperative pneumonia
.
Read the detailed description
Study design This double-blinded, prospective, randomized comparative study will be conducted in Fayoum University hospital after the approval of local Institutional Ethics Committee and local institutional review board. Written informed consent will be obtained from all patients for these scientific contributions before recruitment and randomization.
Randomization, Allocation Concealment and blinding Patients will be randomly allocated into one of 2 parallel groups (40 in each group) based on sample size. Randomization will be achieved using computer-generated random numbering of each study patient. Allocation concealment will be insured using Sequentially Numbered, Opaque, Sealed Envelopes (SNOSE), prepared by a researcher not involved in patient recruitment or outcome assessment. The block tray and necessary equipment will be prepared by an independent anesthesiologist not involved in patient assessment. The patient and researcher who collects the data after the block will be blinded to the study group. All study outcomes will be evaluated by a dedicated anesthesiologist who will be blinded to the group allocation.Patients will be randomized into 2 groups.
Group (S) patients who will receive sacral erector spinae plane block. Group (G) patients who will receive pericapsular nerve group block. Anesthesia procedure
- The study protocol, sacral erector plane block, PENG block and the numerical pain rating score (NPRS) will be explained to each patient during the preanesthetic counselling. The (NPRS) is 11-point numeric scale ranges from 0 to 10, (where score 0 =no pain and 10 =worst pain imaginable) .
- . Before the participants will be admitted in this study, the purpose and nature of the study, as well as the risk-benefit assessment will be explained to them. An informed consent will be obtained from participants. Patients will fast for about 6 to 8 hours for solid meals, for 4 hours for non-clear liquids and for 2 hours for clear liquids before surgery .
Anesthetic technique
- Perioperative anesthesia management will be according to our hospital routine protocol.
- An intravenous cannula will be inserted in the hand and standard monitoring (noninvasive blood pressure, electrocardiography, and pulse oximetry) will be applied.
- In all patients, spinal anesthesia will be performed in the sitting position. The midline at level of the L3-4 and L4-5 intervertebral spaces will be identified, and spinal anesthesia will be administered using 25-gauge Quincke needle.
- Patients will be immediately placed in the supine position. Spinal anesthesia will be considered successful when a bilateral block to T12, as assessed by loss of cold (cold ice) and pain (a 23-gauge needle) sensations, will be established 10 minutes after the intrathecal injection, the surgery will be done using a lateral approach and a lateral decubitus position. Local Anesthetic Dose, Safety, and Emergency Preparedness
- Sacral ESPB: 30 mL of 0.25% bupivacaine HCl (plain), equivalent to 75 mg. PENG block: 20 mL of 0.25% bupivacaine HCl (plain), equivalent to 50 mg . Both doses fall well within the recommended maximum safe dose for elderly patients and selected per anatomical requirements and RCT evidence. The maximum safe dose of plain bupivacaine will be strictly adhered to, defined as 2 mg/kg, not exceeding an absolute maximum of 150 mg.
- Slow Incremental Injection: The standard practice is to inject the local anesthetic under ultrasound guidance in small boluses, commonly 5-10 mL at a time, followed by aspiration to rule out intravascular placement and systemic toxicity.
- Emergency preparedness measures included: (i) Lipid rescue protocol availability: 20% Intralipid solution will be readily available for immediate intravenous administration in the event of local anesthetic systemic toxicity (LAST), according to ASRA guidelines. (ii) Monitoring for LAST: Continuous monitoring of neurological status (e.g., dizziness, perioral numbness, seizures) and cardiovascular parameters (ECG, blood pressure, heart rate) will be performed throughout the procedure and during the immediate post-block period. (iii) Allergic/anaphylaxis management: Emergency medications (adrenaline, antihistamines, corticosteroids) and resuscitation equipment will be available, with a predefined protocol for prompt management of any hypersensitivity reactions. (iv)Emergency airway management equipment will be available at the bed side. (V) Stop rule will be applied if unexpected adverse events (e.g., severe hypotension, arrhythmia, LA toxicity). Postoperative analgesia protocol All patients will receive standardized multimodal analgesia. Paracetamol (1 g every 6 hours) and NSAIDs (unless contraindicated) will be administered as routine analgesics. Opioids will be used as rescue medication according to a unified protocol for both groups. This standardized regimen aims to minimize confounding and ensure that differences in pain scores are attributable to the regional techniques.
- Being tested
- Sacral erector spinae plane block, PENG block
- Medical subject headings
- Femoral Neck Fractures, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacral erector spinae plane blockProcedure or surgery
the curvilinear transducer of ultrasound will be placed parallel to the median sacral crest pointing towards the caudal direction. After visualizing the S1 median sacral crest, the transducer will be shifted caudally. When the S2 level will be reached, the transducer will be moved 3-4 cm laterally. Then, the intermediate crest (IC) will be detected in the parasagittal plane. At the S2-3 level, a 22-gauge Quincke spinal needle,90 mm in length will be advanced in the caudo-cranial direction under the erector spinae muscle but superficial to the transverse process at the sacral level and achieving bone contact (at depth from 3cm to 5cm according to subcutaneous tissue thickness and muscle mass). Then local anesthetic (LA)(0.5mL/kg of bupivacaine 0.25%) will be injected following negative aspiration ensuring that total administered dose remains below toxicity threshold(150mg). The correct spread is confirmed by visualizing LA separating the erector spinae muscle from the underlying bone.
PENG blockProcedure or surgery
The ultrasound transducer will be placed in a transverse orientation, medial and caudal to the anterosuperior iliac spine in order to identify the anteroinferior iliac spine, the iliopubic eminence and the psoas tendon. Using an in-plane technique and a lateral-to-medial direction, a 22-gauge Quincke spinal needle,90 mm in length will be advanced until its tip will be positioned on the periosteum dorsal to the psoas tendon (3-5cm from the skin). The local anesthetic (0.5mL/kg of bupivacaine 0.25%) will be injected following negative aspiration ensuring that total administered dose remains below toxicity threshold(150mg). The accurate position of the needle will be confirmed by hydro dissection and spread under the ilio-psoas muscle. To avoid femoral nerve involvement, and therefore quadriceps weakness ,the investigator will perform lateral needle placement (away from the undersurface of the iliopsoas tendon), also lower volume is needed, slower injection.
| Study group | Role | What they receive |
|---|---|---|
| S group | Active comparator | This group will receive sacral erector spinae plane block in the operating room, after spinal anesthesia and before skin incision, when the patient will be in the lateral decubitus position, aseptic conditions will be provided for the block. Receives: Procedure: Sacral erector spinae plane block |
| G group | Active comparator | This group will receive PENG Block in the operating room, after spinal anesthesia and before skin incision. Patients will be placed in the supine position, aseptic conditions will be provided for the block. Receives: Procedure: PENG block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical pain rating score (NPRS) after surgery at rest.
Numerical Pain Rating Scale (NPRS) is a subjective measure where patients rate their pain on an 11-point numerical scale. The scale ranges from 0 to 10, where 0 represents "no pain" and 10 represents "worst possible pain." Higher scores indicate a worse outcome (greater pain intensity).
Measured: At twelve hours postoperatively
Secondary outcomes (10)
Numerical Pain Rating Scale(NPRS) during movement and at rest in 24 h after surgery at (2,4,6,8,12,18,24)
NPRS (Numerical Pain Rating Scale) is assessed during movement and at rest at 2, 4, 6, 8, 12, 18, and 24 hours after surgery. The scale ranges from 0 to 10, where 0 represents "no pain" and 10 represents "worst possible pain." Higher scores indicate a worse outcome (greater pain intensity).
Measured: At 2, 4, 6, 8, 12, 18, and 24 hours postoperatively.
Cumulative morphine consumption in 24 hours in mg
cumulative amount of morphine in mg (will be consumed in the first 24 hours)will be measured
Measured: During the first 24 hours postoperatively
Time for first rescue analgesia (hours), standard rescue analgesia (Morphine PCA or IV (dose specified)
The time from the end of surgery until the first request for rescue analgesia (provided as Morphine PCA or IV) during the first 24 hours postoperatively.
Measured: In the first 24 hours postoperatively
Intraoperative opioids consumption.
Cumulative intraoperative opioid dose, converted to Morphine Milligram Equivalents (MME) for standardized comparison between groups, administered throughout the surgical procedure
Measured: Intraoperative peroid
Inability to perform physiotherapy at 24 hours.
The incidence of inability to perform the standardized physiotherapy protocol due to pain or motor block at 24 hours postoperatively .
Measured: At 24 hours postoperatively.
Delirium assessment (CAM score), a diagnosis of delirium is made if the patient has both (Acute onset and fluctuating course) and (Inattention), plus either (Disorganized thinking) or (Altered level of f consciousness) 20
Incidence of postoperative delirium, assessed using the Confusion Assessment Method (CAM) algorithm. A positive diagnosis requires the presence of: (1) acute onset and fluctuating course, (2) inattention, AND either (3) disorganized thinking OR (4) altered level of consciousness.
Measured: Twice daily (every 12 hours) for the first 72 hours postoperatively.
The incidence of block-related adverse events (ie, vascular puncture, LA toxicity).
The incidence of block-related complications, specifically accidental vascular puncture (defined as aspiration of blood during needle placement) and Local Anesthetic Systemic Toxicity (LAST) (defined by neurological or cardiovascular signs following LA injection).
Measured: For Vascular Puncture: "Intraoperatively, during the performance of the nerve block. For LA Toxicity (LAST): "From the time of injection until 60 minutes post-procedure.
Incidence of quadriceps motor block at 3,6,12,24 hours postoperatively
Incidence of quadriceps motor block, assessed using the Medical Research Council (MRC) scale for muscle strength (0 to 5). Motor block is defined as any reduction in strength (MRC score < 5) during active knee extension against resistance.
Measured: At 3, 6, 12, and 24 hours postoperatively.
Opioid related side effects (ie, nausea, vomiting, urine retention, respiratory depression)
Incidence of opioid-induced respiratory depression (OIRD), defined as a respiratory rate < 8-10 breaths/minute or oxygen saturation (SpO2) < 90% for more than 1 minute, or any other related side effects like nausea, vomiting, urine retention.
Measured: From the time of the first dose up to 24 hours post-administration.
Length of stay in hospital.
The number of days from the date of surgery until the date of hospital discharge.
Measured: From the day of surgery until hospital discharge, assessed up to 30 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start1 Feb 2026
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Hip ArthroplastyStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fayoum University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ahmed Hamed, Fayoum University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07442721
- Sponsor's protocol ID
- D 447
- Status last verified
- Feb 2026
- First submitted
- 19 Feb 2026
- Last updated
- 3 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Inouye SK, van Dyck CH, Alessi CA, Balkin S, Siegal AP, Horwitz RI. Clarifying confusion: the confusion assessment method. A new method for detection of delirium. Ann Intern Med. 1990 Dec 15;113(12):941-8. doi: 10.7326/0003-4819-113-12-941.
PubMed 2240918Johnson C. Measuring Pain. Visual Analog Scale Versus Numeric Pain Scale: What is the Difference? J Chiropr Med. 2005 Winter;4(1):43-4. doi: 10.1016/S0899-3467(07)60112-8.
PubMed 19674646Childs JD, Piva SR, Fritz JM. Responsiveness of the numeric pain rating scale in patients with low back pain. Spine (Phila Pa 1976). 2005 Jun 1;30(11):1331-4. doi: 10.1097/01.brs.0000164099.92112.29.
PubMed 15928561Studzinska D, Pabjanczyk I, Polok K, Szczeklik W. Perioperative utilization of tranexamic acid in total knee and hip arthroplasty procedures in Poland - a survey-based study. Anaesthesiol Intensive Ther. 2024;56(3):206-207. doi: 10.5114/ait.2024.142670. No abstract available.
PubMed 39451168Kutnik P, Bierut M, Rypulak E, Trwoga A, Wroblewska K, Marzeda P, Kosmider K, Kamieniak M, Pajak A, Wolanin N, Gebska-Wolinska M, Borys M. The use of the ERAS protocol in malnourished and properly nourished patients undergoing elective surgery: a questionnaire study. Anaesthesiol Intensive Ther. 2023;55(5):330-334. doi: 10.5114/ait.2023.134190.
PubMed 38282499Lavand'homme PM, Kehlet H, Rawal N, Joshi GP; PROSPECT Working Group of the European Society of Regional Anaesthesia and Pain Therapy (ESRA). Pain management after total knee arthroplasty: PROcedure SPEcific Postoperative Pain ManagemenT recommendations. Eur J Anaesthesiol. 2022 Sep 1;39(9):743-757. doi: 10.1097/EJA.0000000000001691. Epub 2022 Jul 20.
PubMed 35852550Luo D, Wan X, Liu J, Tong T. Optimally estimating the sample mean from the sample size, median, mid-range, and/or mid-quartile range. Stat Methods Med Res. 2018 Jun;27(6):1785-1805. doi: 10.1177/0962280216669183. Epub 2016 Sep 27.
PubMed 27683581Aliste 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 34290085Giron-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 30063657Senthil KS, Kumar P, Ramakrishnan L. Comparison of Pericapsular Nerve Group Block versus Fascia Iliaca Compartment Block as Postoperative Pain Management in Hip Fracture Surgeries. Anesth Essays Res. 2021 Oct-Dec;15(4):352-356. doi: 10.4103/aer.aer_119_21. Epub 2022 Mar 1.
PubMed 35422548Birnbaum K, Prescher A, Hessler S, Heller KD. The sensory innervation of the hip joint--an anatomical study. Surg Radiol Anat. 1997;19(6):371-5. doi: 10.1007/BF01628504.
PubMed 9479711Aksu C, Gurkan Y. Sacral Erector Spinae Plane Block with longitudinal midline approach: Could it be the new era for pediatric postoperative analgesia? J Clin Anesth. 2020 Feb;59:38-39. doi: 10.1016/j.jclinane.2019.06.007. Epub 2019 Jun 13. No abstract available.
PubMed 31203111Kilicaslan A, Uyel Y. Novel lumbosacral approach for erector spinae plane block (LS-ESPB) in hip surgery. J Clin Anesth. 2020 Mar;60:83-84. doi: 10.1016/j.jclinane.2019.08.040. Epub 2019 Aug 30. No abstract available.
PubMed 31476627Kukreja P, Deichmann P, Selph JP, Hebbard J, Kalagara H. Sacral Erector Spinae Plane Block for Gender Reassignment Surgery. Cureus. 2020 Apr 14;12(4):e7665. doi: 10.7759/cureus.7665.
PubMed 32419993Piraccini E, Antioco M, Maitan S. Ultrasound guided sacral erector spinae plane block: A useful tool for radicular pain treatment. J Clin Anesth. 2020 Feb;59:11-12. doi: 10.1016/j.jclinane.2019.06.011. Epub 2019 Jun 6. No abstract available.
PubMed 31176955
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sacral Erector Spinae Plane Block Versus Pericapsular Nerve Group Block For Analgesia In Hip Hemi Arthroplasty: A Randomized Comparative Study
- ClinicalTrials.gov ID
- NCT07442721
- Acronym / sponsor ID
- D 447
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Fayoum University HospitalUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 2 Mar 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.
Sacral erector spinae plane block(S-ESPB) has been recently described. Case reports are showing that it is useful in various types of surgery. In case presentations, it has been reported as effective in providing analgesia in the posterior branches of the sacral nerves in pilonidal sinus surgery, in the treatment of radicular pain at the L5 - S1 level, after a sex reassignment operation and hypospadias surgery, and its use in combination with lumbar ESPB for analgesia was reported after hip prosthesis surgery . Described in 2018, pericapsular nerve group (PENG) block selectively targets the articular branches of the femoral and accessory obturator nerves thereby providing potential motorsparing analgesia for hip surgery
. Recent studies found that PENG block targets the articular branches of the femoral and accessory obturator nerves, only anesthetizes the anterior hip joint sparing posterior part , as well as there was a motor impairment after block which is from local anesthetic (LA) diffusion to the femoral nerve
. Motor-sparing regional anesthesia techniques have emerged as a safer alternative, balancing effective pain relief with the preservation of quadriceps function . These techniques align with Enhanced Recovery After Surgery (ERAS) protocols, which emphasize multimodal pain control, opioid minimization, and early mobility to reduce complications such as venous thromboembolism (VTE) and postoperative pneumonia
.
Detailed description
Study design This double-blinded, prospective, randomized comparative study will be conducted in Fayoum University hospital after the approval of local Institutional Ethics Committee and local institutional review board. Written informed consent will be obtained from all patients for these scientific contributions before recruitment and randomization.
Randomization, Allocation Concealment and blinding Patients will be randomly allocated into one of 2 parallel groups (40 in each group) based on sample size. Randomization will be achieved using computer-generated random numbering of each study patient. Allocation concealment will be insured using Sequentially Numbered, Opaque, Sealed Envelopes (SNOSE), prepared by a researcher not involved in patient recruitment or outcome assessment. The block tray and necessary equipment will be prepared by an independent anesthesiologist not involved in patient assessment. The patient and researcher who collects the data after the block will be blinded to the study group. All study outcomes will be evaluated by a dedicated anesthesiologist who will be blinded to the group allocation.Patients will be randomized into 2 groups.
Group (S) patients who will receive sacral erector spinae plane block. Group (G) patients who will receive pericapsular nerve group block. Anesthesia procedure
- The study protocol, sacral erector plane block, PENG block and the numerical pain rating score (NPRS) will be explained to each patient during the preanesthetic counselling. The (NPRS) is 11-point numeric scale ranges from 0 to 10, (where score 0 =no pain and 10 =worst pain imaginable) .
- . Before the participants will be admitted in this study, the purpose and nature of the study, as well as the risk-benefit assessment will be explained to them. An informed consent will be obtained from participants. Patients will fast for about 6 to 8 hours for solid meals, for 4 hours for non-clear liquids and for 2 hours for clear liquids before surgery .
Anesthetic technique
- Perioperative anesthesia management will be according to our hospital routine protocol.
- An intravenous cannula will be inserted in the hand and standard monitoring (noninvasive blood pressure, electrocardiography, and pulse oximetry) will be applied.
- In all patients, spinal anesthesia will be performed in the sitting position. The midline at level of the L3-4 and L4-5 intervertebral spaces will be identified, and spinal anesthesia will be administered using 25-gauge Quincke needle.
- Patients will be immediately placed in the supine position. Spinal anesthesia will be considered successful when a bilateral block to T12, as assessed by loss of cold (cold ice) and pain (a 23-gauge needle) sensations, will be established 10 minutes after the intrathecal injection, the surgery will be done using a lateral approach and a lateral decubitus position. Local Anesthetic Dose, Safety, and Emergency Preparedness
- Sacral ESPB: 30 mL of 0.25% bupivacaine HCl (plain), equivalent to 75 mg. PENG block: 20 mL of 0.25% bupivacaine HCl (plain), equivalent to 50 mg . Both doses fall well within the recommended maximum safe dose for elderly patients and selected per anatomical requirements and RCT evidence. The maximum safe dose of plain bupivacaine will be strictly adhered to, defined as 2 mg/kg, not exceeding an absolute maximum of 150 mg.
- Slow Incremental Injection: The standard practice is to inject the local anesthetic under ultrasound guidance in small boluses, commonly 5-10 mL at a time, followed by aspiration to rule out intravascular placement and systemic toxicity.
- Emergency preparedness measures included: (i) Lipid rescue protocol availability: 20% Intralipid solution will be readily available for immediate intravenous administration in the event of local anesthetic systemic toxicity (LAST), according to ASRA guidelines. (ii) Monitoring for LAST: Continuous monitoring of neurological status (e.g., dizziness, perioral numbness, seizures) and cardiovascular parameters (ECG, blood pressure, heart rate) will be performed throughout the procedure and during the immediate post-block period. (iii) Allergic/anaphylaxis management: Emergency medications (adrenaline, antihistamines, corticosteroids) and resuscitation equipment will be available, with a predefined protocol for prompt management of any hypersensitivity reactions. (iv)Emergency airway management equipment will be available at the bed side. (V) Stop rule will be applied if unexpected adverse events (e.g., severe hypotension, arrhythmia, LA toxicity). Postoperative analgesia protocol All patients will receive standardized multimodal analgesia. Paracetamol (1 g every 6 hours) and NSAIDs (unless contraindicated) will be administered as routine analgesics. Opioids will be used as rescue medication according to a unified protocol for both groups. This standardized regimen aims to minimize confounding and ensure that differences in pain scores are attributable to the regional techniques.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| S group | Active comparator | Procedure: Sacral erector spinae plane blockThis group will receive sacral erector spinae plane block in the operating room, after spinal anesthesia and before skin incision, when the patient will be in the lateral decubitus position, aseptic conditions will be provided for the block. |
| G group | Active comparator | Procedure: PENG blockThis group will receive PENG Block in the operating room, after spinal anesthesia and before skin incision. Patients will be placed in the supine position, aseptic conditions will be provided for the block. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with ages from 50 to 90 years of either gender, with diagnosis of intracapsular neck of femur fracture scheduled for elective hip hemiarthroplasty • Patients with an American Society of Anesthesiologists (ASA) physical status I to III.
Key exclusion criteria (10 listed)
- • Patient refusal.
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 |
|---|---|---|
| Sacral erector spinae plane blockthe curvilinear transducer of ultrasound will be placed parallel to the median sacral crest pointing towards the caudal direction. After visualizing the S1 median sacral crest, the transducer will be shifted caudally. When the S2 level will be reached, the transducer will be moved 3-4 cm laterally. Then, the intermediate crest (IC) will be detected in the parasagittal plane. At the S2-3 level, a 22-gauge Quincke spinal needle,90 mm in length will be advanced in the caudo-cranial direction under the erector spinae muscle but superficial to the transverse process at the sacral level and achieving bone contact (at depth from 3cm to 5cm according to subcutaneous tissue thickness and muscle mass). Then local anesthetic (LA)(0.5mL/kg of bupivacaine 0.25%) will be injected following negative aspiration ensuring that total administered dose remains below toxicity threshold(150mg). The correct spread is confirmed by visualizing LA separating the erector spinae muscle from the underlying bone. | Procedure or surgery | S group |
| PENG blockThe ultrasound transducer will be placed in a transverse orientation, medial and caudal to the anterosuperior iliac spine in order to identify the anteroinferior iliac spine, the iliopubic eminence and the psoas tendon. Using an in-plane technique and a lateral-to-medial direction, a 22-gauge Quincke spinal needle,90 mm in length will be advanced until its tip will be positioned on the periosteum dorsal to the psoas tendon (3-5cm from the skin). The local anesthetic (0.5mL/kg of bupivacaine 0.25%) will be injected following negative aspiration ensuring that total administered dose remains below toxicity threshold(150mg). The accurate position of the needle will be confirmed by hydro dissection and spread under the ilio-psoas muscle. To avoid femoral nerve involvement, and therefore quadriceps weakness ,the investigator will perform lateral needle placement (away from the undersurface of the iliopsoas tendon), also lower volume is needed, slower injection. | Procedure or surgery | G group |
Primary outcome
Numerical pain rating score (NPRS) after surgery at rest.
Time frame: At twelve hours postoperatively
Numerical Pain Rating Scale (NPRS) is a subjective measure where patients rate their pain on an 11-point numerical scale. The scale ranges from 0 to 10, where 0 represents "no pain" and 10 represents "worst possible pain." Higher scores indicate a worse outcome (greater pain intensity).
10 secondary outcomes
Numerical Pain Rating Scale(NPRS) during movement and at rest in 24 h after surgery at (2,4,6,8,12,18,24)
Time frame: At 2, 4, 6, 8, 12, 18, and 24 hours postoperatively.
Cumulative morphine consumption in 24 hours in mg
Time frame: During the first 24 hours postoperatively
Time for first rescue analgesia (hours), standard rescue analgesia (Morphine PCA or IV (dose specified)
Time frame: In the first 24 hours postoperatively
Intraoperative opioids consumption.
Time frame: Intraoperative peroid
Inability to perform physiotherapy at 24 hours.
Time frame: At 24 hours postoperatively.
Delirium assessment (CAM score), a diagnosis of delirium is made if the patient has both (Acute onset and fluctuating course) and (Inattention), plus either (Disorganized thinking) or (Altered level of f consciousness) 20
Time frame: Twice daily (every 12 hours) for the first 72 hours postoperatively.
The incidence of block-related adverse events (ie, vascular puncture, LA toxicity).
Time frame: For Vascular Puncture: "Intraoperatively, during the performance of the nerve block. For LA Toxicity (LAST): "From the time of injection until 60 minutes post-procedure.
Incidence of quadriceps motor block at 3,6,12,24 hours postoperatively
Time frame: At 3, 6, 12, and 24 hours postoperatively.
Opioid related side effects (ie, nausea, vomiting, urine retention, respiratory depression)
Time frame: From the time of the first dose up to 24 hours post-administration.
Length of stay in hospital.
Time frame: From the day of surgery until hospital discharge, assessed up to 30 days.
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 3 Mar 2026.
- Background: PubMed 2240918Inouye SK, van Dyck CH, Alessi CA, Balkin S, Siegal AP, Horwitz RI. Clarifying confusion: the confusion assessment method. A new method for detection of delirium. Ann Intern Med. 1990 Dec 15;113(12):941-8. doi: 10.7326/0003-4819-113-12-941.
- Background: PubMed 19674646Johnson C. Measuring Pain. Visual Analog Scale Versus Numeric Pain Scale: What is the Difference? J Chiropr Med. 2005 Winter;4(1):43-4. doi: 10.1016/S0899-3467(07)60112-8.
- Background: PubMed 15928561Childs JD, Piva SR, Fritz JM. Responsiveness of the numeric pain rating scale in patients with low back pain. Spine (Phila Pa 1976). 2005 Jun 1;30(11):1331-4. doi: 10.1097/01.brs.0000164099.92112.29.
- Background: PubMed 39451168Studzinska D, Pabjanczyk I, Polok K, Szczeklik W. Perioperative utilization of tranexamic acid in total knee and hip arthroplasty procedures in Poland - a survey-based study. Anaesthesiol Intensive Ther. 2024;56(3):206-207. doi: 10.5114/ait.2024.142670. No abstract available.
- Background: PubMed 38282499Kutnik P, Bierut M, Rypulak E, Trwoga A, Wroblewska K, Marzeda P, Kosmider K, Kamieniak M, Pajak A, Wolanin N, Gebska-Wolinska M, Borys M. The use of the ERAS protocol in malnourished and properly nourished patients undergoing elective surgery: a questionnaire study. Anaesthesiol Intensive Ther. 2023;55(5):330-334. doi: 10.5114/ait.2023.134190.
- Background: PubMed 35852550Lavand'homme PM, Kehlet H, Rawal N, Joshi GP; PROSPECT Working Group of the European Society of Regional Anaesthesia and Pain Therapy (ESRA). Pain management after total knee arthroplasty: PROcedure SPEcific Postoperative Pain ManagemenT recommendations. Eur J Anaesthesiol. 2022 Sep 1;39(9):743-757. doi: 10.1097/EJA.0000000000001691. Epub 2022 Jul 20.
- Background: PubMed 27683581Luo D, Wan X, Liu J, Tong T. Optimally estimating the sample mean from the sample size, median, mid-range, and/or mid-quartile range. Stat Methods Med Res. 2018 Jun;27(6):1785-1805. doi: 10.1177/0962280216669183. Epub 2016 Sep 27.
- 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 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.
- Background: PubMed 35422548Senthil KS, Kumar P, Ramakrishnan L. Comparison of Pericapsular Nerve Group Block versus Fascia Iliaca Compartment Block as Postoperative Pain Management in Hip Fracture Surgeries. Anesth Essays Res. 2021 Oct-Dec;15(4):352-356. doi: 10.4103/aer.aer_119_21. Epub 2022 Mar 1.
- Background: PubMed 9479711Birnbaum K, Prescher A, Hessler S, Heller KD. The sensory innervation of the hip joint--an anatomical study. Surg Radiol Anat. 1997;19(6):371-5. doi: 10.1007/BF01628504.
- Background: PubMed 31203111Aksu C, Gurkan Y. Sacral Erector Spinae Plane Block with longitudinal midline approach: Could it be the new era for pediatric postoperative analgesia? J Clin Anesth. 2020 Feb;59:38-39. doi: 10.1016/j.jclinane.2019.06.007. Epub 2019 Jun 13. No abstract available.
- Individual participant dataSharing planned: No
Related trials for Hip Arthroplasty
Enrolling by invitation
Comparison of Functional Results of ADM X3-MoP Cup (Stryker) and a CoC Cup (Zimmer) in Young Patients
Arthroplasties, Hip Replacement
Recruiting
Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty
Osteoarthritis, Hip, Hip Osteoarthritis
Recruiting
Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
Arthropathy of Hip, Hip Osteoarthritis
RecruitingPhase 4
PENG vs L-ESPB With S-ESPB for Analgesia in Total Hip Arthroplasty
Hip Osteoarthritis, Hip Arthropathy
Recruiting
Intravenous Dexmedetomidine as a Perioperative Autonomic-Immune Neuromodulator
Hip Osteoarthritis
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sacral erector spinae plane block and PENG block in people with Hip Arthroplasty and Hip Fracture Surgeries, run by Fayoum University Hospital 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 1 inclusion and 10 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 3 Mar 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.
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 Samar Ahmed Ramadan (01028384348, sar15@fayoum.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical pain rating score (NPRS) after surgery at rest. (time frame: At twelve 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 NCT07442721, which also lists 19 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 3 Mar 2026.