PainNCT05773365
PENG Block Plus Local Infiltration Compared to PENG Block Alone in Hip Surgery
A study testing PENG block with or without local anaesthetic infiltration in people with Pain and Hip Fractures, run by Suez Canal University at 1 site in Egypt.
Trial summary
Summary: Pain control after hip surgery is quite important for patients' recovery. Many regional techniques are available with the focus on motor sparing block to speed patient recovery. The investigators will compare pericapsular nerve group (PENG) block in addition to local skin infiltration to PENG block alone. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain, Hip Fractures, Postoperative Pain
- What is being tested?
- PENG block with or without local anaesthetic infiltration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Jul 2023to 1 Jul 2025
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anaesthesiology (ASA) 1-3
- Traumatic hip surgeries (total hip arthroplasty, hemiarthroplasty, Dynamic hip screw).
Who cannot join
- Patient with cognitive impairment.
- Patient weight < 50 kg.
- Allergy to medications used.
- Chronic kidney disease. (serum creatinine > 2.5 mg/dl).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Analgesic Effect of Added Local Infiltration to Pericapsular Nerve Group Block in Traumatic Hip Surgery
Summary:
Pain control after hip surgery is quite important for patients' recovery. Many regional techniques are available with the focus on motor sparing block to speed patient recovery.
Read more
The investigators will compare pericapsular nerve group (PENG) block in addition to local skin infiltration to PENG block alone. The study population will be included for patient traumatic hip surgery. The study population will be divided into group. First group will receive PENG block and local anaesthetics infiltration and second group will receive PENG block.
Our primary outcome is to compare numeric rating scale (NRS) between studied groups, and morphine requirements in the first 24 hours as a secondary outcome.
Read the detailed description
Aim of the study:
The aim of the study is to improve quality of patient's post-operative recovery after hip surgery.
Study objectives:
To compare Patient numeric rating scale (NRS) scores after hip surgery for patients receiving PENG block and local skin infiltration
Study question:
Will PENG block and local infiltration provide significant analgesia for hip surgery than PENG block alone?
Null Hypothesis:
Local infiltration addition to PENG block will not provide significant analgesia to PENG block alone.
Alternative hypothesis:
Local infiltration addition to PENG block will provide significant superior analgesia to PENG alone.
Study Design:
Single blinded randomized clinical trial. Ethical approval will be obtained from Suez Canal University. Patients' enrolment will be obtained preoperatively. Patients' demographic data will be recorded (age, weight, BMI, and gender).
An informed consent will be obtained during enrolment explaining the aim of the study and complication of the techniques. Patient will have the right to withdraw from the study at any time.
Patients will be randomly allocated to either of the studied group through the following method:
Randomization of the patients meeting the inclusion criteria will be achieved by a computer-generated random sequence, and this sequence will be concealed in sealed numbered envelopes, labelled Group A (study group) carry the label Group B (control group).
Methods:
Group A (study group) will receive both PENG block and local infiltration at the end of the surgery. Group B (control group) will receive PENG block without local infiltration.
Spinal anaesthesia will be administered to the patient using 10-12.5 mg heavy 0.5% bupivacaine at L3-L5 lumbar spine using 25 G spinal needle.
If spinal anaesthesia is contraindicated or failed, patients will have general anaesthetics.
General anaesthesia will be induced with 1-2 mcg/kg fentanyl, propofol 1-2 mg/kg, and appropriate muscle relaxant.
Block will be administered for trauma patients PENG block will be administered as following:
A curvilinear US sound probe will be placed in a transverse plane over anterior superior iliac spine and rotated 45 degrees anticlockwise till identifying femoral vessels, iliopubic eminence, iliopsoas muscle tendon in the view. A 100 mm echogenic needles (SonoPlex STIM, Germany) will be advanced from lateral to medial and injecting 20 ml of 0.25% bupivacaine below the psoas tendon.
A 20 ml of 0.25% bupivacaine will be infiltrated by the surgeons to the tissues at the end of the surgery.
Pain management:
All patients will receive 1g of paracetamol, 30 mg Ketorolac, and 8 mg Dexamethasone after spinal anaesthesia.
Postoperatively 1g of paracetamol four times a day, ketorolac 30 mg twice a day for 48 hours. Intravenous morphine 2 mg every 10 minutes will be given to the patient if NRS score ≥ 4 till pain is controlled as rescue analgesics.
Morphine requirement will be assessed in recovery and then every 6 hours, in the first 24 hours after surgery. If the pain score > 4, patient will get 2 mg IV morphine. Pain will be reassessed after 10 minutes for further analgesia requirement.
- Conditions
- Pain, Hip Fractures, Postoperative Pain, Postoperative Analgesia
- Being tested
- PENG block with or without local anaesthetic infiltration
- Medical subject headings
- Pain, Hip Fractures, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PENG block with or without local anaesthetic infiltrationOther
As mentioned.
| Study group | Role | What they receive |
|---|---|---|
| Pericapsular Nerve Group Block plus local infiltration | Experimental | Group A (study group) will receive both PENG block and local infiltration at the end of the surgery.
Spinal anaesthesia will be administered to the patient using 7.5-12.5 mg heavy 0.5% bupivacaine at L3-L5 lumbar spine using 25 G spinal needle.
If spinal anaesthesia is contraindicated or failed, patients will have general anaesthetics.
General anaesthesia will be induced with 2-3 mcg/kg fentanyl, Propofol 1-2 mg/kg titrated to effect, and muscle relaxant if required.
PENG block will be administered according to the description by injecting 20 ml of 0.25% bupivacaine below the psoas tendon.
A 20 ml of 0.25% bupivacaine will be infiltrated by the surgeons to the tissues at the end of the surgery. Receives: Other: PENG block with or without local anaesthetic infiltration |
| Pericapsular Nerve Group Block | Active comparator | In Group B, only PENG block will be administered in this arm Receives: Other: PENG block with or without local anaesthetic infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scores
The difference in patient numeric rating scale (NRS). 11 points scale, where 0 means no pain and 10 is worst possible pain. The higher pain scores means worse outcome between both groups.
Measured: 24 hours
Secondary outcomes (1)
Morphine requirement
Postoperative morphine requirement
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2023
- Study start18 Jul 2023
- Primary completion1 May 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for PainStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eslam Albayadi, Principal investigator, Suez Canal University, Ring Road, Ismailia, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05773365
- Sponsor's protocol ID
- 5177
- Status last verified
- Dec 2024
- First submitted
- 6 Mar 2023
- Last updated
- 18 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Young AC, Buvanendran A. Pain management for total hip arthroplasty. J Surg Orthop Adv. 2014 Spring;23(1):13-21. doi: 10.3113/jsoa.2014.0013.
PubMed 24641893Tran DQ, Salinas FV, Benzon HT, Neal JM. Lower extremity regional anesthesia: essentials of our current understanding. Reg Anesth Pain Med. 2019 Jan 11:rapm-2018-000019. doi: 10.1136/rapm-2018-000019. Online ahead of print.
PubMed 30635506Giron-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 30063657Pascarella G, Costa F, Del Buono R, Pulitano R, Strumia A, Piliego C, De Quattro E, Cataldo R, Agro FE, Carassiti M; collaborators. Impact of the pericapsular nerve group (PENG) block on postoperative analgesia and functional recovery following total hip arthroplasty: a randomised, observer-masked, controlled trial. Anaesthesia. 2021 Nov;76(11):1492-1498. doi: 10.1111/anae.15536. Epub 2021 Jul 1.
PubMed 34196965Lin DY, Brown B, Morrison C, Fraser NS, Chooi CSL, Cehic MG, McLeod DH, Henningsen MD, Sladojevic N, Kroon HM, Jaarsma RL. The Pericapsular Nerve Group (PENG) block combined with Local Infiltration Analgesia (LIA) compared to placebo and LIA in hip arthroplasty surgery: a multi-center double-blinded randomized-controlled trial. BMC Anesthesiol. 2022 Aug 6;22(1):252. doi: 10.1186/s12871-022-01787-2.
PubMed 35933328
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Analgesic Effect of Added Local Infiltration to Pericapsular Nerve Group Block in Traumatic Hip Surgery
- ClinicalTrials.gov ID
- NCT05773365
- Acronym / sponsor ID
- 5177
- Conditions
- Pain, Hip Fractures, Postoperative Pain, Postoperative Analgesia
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 18 Jul 2023 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 17 Mar 2023 (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.
Summary:
Pain control after hip surgery is quite important for patients' recovery. Many regional techniques are available with the focus on motor sparing block to speed patient recovery.
The investigators will compare pericapsular nerve group (PENG) block in addition to local skin infiltration to PENG block alone. The study population will be included for patient traumatic hip surgery. The study population will be divided into group. First group will receive PENG block and local anaesthetics infiltration and second group will receive PENG block.
Our primary outcome is to compare numeric rating scale (NRS) between studied groups, and morphine requirements in the first 24 hours as a secondary outcome.
Detailed description
Aim of the study:
The aim of the study is to improve quality of patient's post-operative recovery after hip surgery.
Study objectives:
To compare Patient numeric rating scale (NRS) scores after hip surgery for patients receiving PENG block and local skin infiltration
Study question:
Will PENG block and local infiltration provide significant analgesia for hip surgery than PENG block alone?
Null Hypothesis:
Local infiltration addition to PENG block will not provide significant analgesia to PENG block alone.
Alternative hypothesis:
Local infiltration addition to PENG block will provide significant superior analgesia to PENG alone.
Study Design:
Single blinded randomized clinical trial. Ethical approval will be obtained from Suez Canal University. Patients' enrolment will be obtained preoperatively. Patients' demographic data will be recorded (age, weight, BMI, and gender).
An informed consent will be obtained during enrolment explaining the aim of the study and complication of the techniques. Patient will have the right to withdraw from the study at any time.
Patients will be randomly allocated to either of the studied group through the following method:
Randomization of the patients meeting the inclusion criteria will be achieved by a computer-generated random sequence, and this sequence will be concealed in sealed numbered envelopes, labelled Group A (study group) carry the label Group B (control group).
Methods:
Group A (study group) will receive both PENG block and local infiltration at the end of the surgery. Group B (control group) will receive PENG block without local infiltration.
Spinal anaesthesia will be administered to the patient using 10-12.5 mg heavy 0.5% bupivacaine at L3-L5 lumbar spine using 25 G spinal needle.
If spinal anaesthesia is contraindicated or failed, patients will have general anaesthetics.
General anaesthesia will be induced with 1-2 mcg/kg fentanyl, propofol 1-2 mg/kg, and appropriate muscle relaxant.
Block will be administered for trauma patients PENG block will be administered as following:
A curvilinear US sound probe will be placed in a transverse plane over anterior superior iliac spine and rotated 45 degrees anticlockwise till identifying femoral vessels, iliopubic eminence, iliopsoas muscle tendon in the view. A 100 mm echogenic needles (SonoPlex STIM, Germany) will be advanced from lateral to medial and injecting 20 ml of 0.25% bupivacaine below the psoas tendon.
A 20 ml of 0.25% bupivacaine will be infiltrated by the surgeons to the tissues at the end of the surgery.
Pain management:
All patients will receive 1g of paracetamol, 30 mg Ketorolac, and 8 mg Dexamethasone after spinal anaesthesia.
Postoperatively 1g of paracetamol four times a day, ketorolac 30 mg twice a day for 48 hours. Intravenous morphine 2 mg every 10 minutes will be given to the patient if NRS score ≥ 4 till pain is controlled as rescue analgesics.
Morphine requirement will be assessed in recovery and then every 6 hours, in the first 24 hours after surgery. If the pain score > 4, patient will get 2 mg IV morphine. Pain will be reassessed after 10 minutes for further analgesia requirement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pericapsular Nerve Group Block plus local infiltration | Experimental | Other: PENG block with or without local anaesthetic infiltrationGroup A (study group) will receive both PENG block and local infiltration at the end of the surgery. Spinal anaesthesia will be administered to the patient using 7.5-12.5 mg heavy 0.5% bupivacaine at L3-L5 lumbar spine using 25 G spinal needle. If spinal anaesthesia is contraindicated or failed, patients will have general anaesthetics. General anaesthesia will be induced with 2-3 mcg/kg fentanyl, Propofol 1-2 mg/kg titrated to effect, and muscle relaxant if required. PENG block will be administered according to the description by injecting 20 ml of 0.25% bupivacaine below the psoas tendon. A 20 ml of 0.25% bupivacaine will be infiltrated by the surgeons to the tissues at the end of the surgery. |
| Pericapsular Nerve Group Block | Active comparator | Other: PENG block with or without local anaesthetic infiltrationIn Group B, only PENG block will be administered in this arm |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anaesthesiology (ASA) 1-3
- Traumatic hip surgeries (total hip arthroplasty, hemiarthroplasty, Dynamic hip screw).
Key exclusion criteria (4 listed)
- Patient with cognitive impairment.
- Patient weight < 50 kg.
- Allergy to medications used.
- Chronic kidney disease. (serum creatinine > 2.5 mg/dl).
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 |
|---|---|---|
| PENG block with or without local anaesthetic infiltrationAs mentioned. | Other | Pericapsular Nerve Group Block, Pericapsular Nerve Group Block plus local infiltration |
Primary outcome
Pain scores
Time frame: 24 hours
The difference in patient numeric rating scale (NRS). 11 points scale, where 0 means no pain and 10 is worst possible pain. The higher pain scores means worse outcome between both groups.
1 secondary outcome
Morphine requirement
Time frame: 24 hours
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 18 Dec 2024.
- Background: PubMed 24641893Young AC, Buvanendran A. Pain management for total hip arthroplasty. J Surg Orthop Adv. 2014 Spring;23(1):13-21. doi: 10.3113/jsoa.2014.0013.
- Background: PubMed 30635506Tran DQ, Salinas FV, Benzon HT, Neal JM. Lower extremity regional anesthesia: essentials of our current understanding. Reg Anesth Pain Med. 2019 Jan 11:rapm-2018-000019. doi: 10.1136/rapm-2018-000019. Online ahead of print.
- 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 34196965Pascarella G, Costa F, Del Buono R, Pulitano R, Strumia A, Piliego C, De Quattro E, Cataldo R, Agro FE, Carassiti M; collaborators. Impact of the pericapsular nerve group (PENG) block on postoperative analgesia and functional recovery following total hip arthroplasty: a randomised, observer-masked, controlled trial. Anaesthesia. 2021 Nov;76(11):1492-1498. doi: 10.1111/anae.15536. Epub 2021 Jul 1.
- Background: PubMed 35933328Lin DY, Brown B, Morrison C, Fraser NS, Chooi CSL, Cehic MG, McLeod DH, Henningsen MD, Sladojevic N, Kroon HM, Jaarsma RL. The Pericapsular Nerve Group (PENG) block combined with Local Infiltration Analgesia (LIA) compared to placebo and LIA in hip arthroplasty surgery: a multi-center double-blinded randomized-controlled trial. BMC Anesthesiol. 2022 Aug 6;22(1):252. doi: 10.1186/s12871-022-01787-2.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Eslam Albayadi principal investigator
Suez Canal University, Ring Road, Ismailia, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PENG block with or without local anaesthetic infiltration in people with Pain and Hip Fractures, run by Suez Canal 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 2 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 18 Dec 2024. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain scores (time frame: 24 hours). 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 NCT05773365, which also lists 5 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 18 Dec 2024; AzTrials last refreshed its copy on 29 Oct 2026.