- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06653894
Postoperative Analgesic Efficacy of PENG and QLB Blocks in Hip Surgeries (PENG vs QLB)
Evaluation of the Postoperative Analgesic Efficacy of Pericapsular Nerve Group (PENG) Block and Quadratus Lumborum Block (QLB) in Hip Surgeries
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a prospective, randomized single-blinded study comparing the postoperative analgesic efficacy of Pericapsular Nerve Group (PENG) block and Quadratus Lumborum Block (QLB) in hip surgeries performed under spinal anesthesia. The study aims to evaluate key outcomes such as the time to first rescue analgesia and total analgesic consumption within the first 48 hours postoperatively. The primary population includes patients over 40 years undergoing elective hip surgery with specific inclusion and exclusion criteria. ninety patients will be divided into two groups, receiving either QLB or PENG block, using a sealed envelope randomization method.
PENG block targets specific nerves to provide analgesia without motor block, preserving motor function. QLB involves injecting a local anesthetic into the fascia near the quadratus lumborum muscle to block thoracoabdominal nerves and provide broad analgesia. Data on pain scores (NRS), opioid consumption, and side effects will be collected at different time points.
The study hypothesizes that both blocks can provide effective postoperative analgesia, with potential benefits such as reduced opioid consumption , but aims to determine which block is superior in efficacy.
The primary aim of this study was to compare the effect of an anterior QLB and PENG block on total opioid analgesic consumption within the first 48 hours postoperatively. The secondary aims were to compare the resting and dynamic NRS scores at 2, 12, 24 and 48 hours postoperatively, the time to first rescue analgesia, and side effects such as nausea, vomiting and quadriceps weakness.
Statistical analysis will be conducted using SPSS, and findings will contribute to the literature on analgesia techniques for hip surgeries.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Istanbul, Turkey, 34255
- Gaziosmanpasa Research and Education Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- "Patients aged over 40 years who are scheduled to undergo hip surgery under spinal anesthesia and classified as ASA 1-3 will be included in the study."
Exclusion Criteria:
- Patients who refuse the procedure.
- Patients who will receive general anesthesia or peripheral nerve blocks such as a combination of femoral and sciatic nerve blocks.
- A history of allergy to local anesthetic agents.
- Patients with a diagnosis of neurocognitive disorders such as dementia or Alzheimer's disease under active neurological follow-up.
- Patients with multiple trauma.
- Patients with severe hearing or vision impairments.
- Patients with a local infection at the site of the block application.
- Patients with a Body Mass Index (BMI) > 35.
- Patients with a history of severe neurological, cardiovascular, renal, or hepatic disease will be excluded from the study.
- Patients who, during the postoperative period, required intensive care unit (ICU) admission for more than one day due to hemodynamic monitoring or sedation, as well as those who developed complications during postoperative follow-up-such as re-operation, postoperative hemorrhage, or the need for advanced cardiopulmonary support-were excluded from the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: QLB Group
In the QLB (Quadratus Lumborum Block) group, patients will be placed in the lateral decubitus position, and the block will be performed using ultrasound guidance
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The quadratus lumborum and psoas major muscles, along with the transverse process of the L4 vertebra, were visualized in the midaxillary line using an in-plane technique. A 22G, 100-mm peripheral block needle (Stimuplex® Ultra; B. Braun Melsungen AG, Melsungen, Germany) was advanced into the subfascial plane between the quadratus lumborum and psoas major muscles, and 1-2 mL of 0.9% saline was injected to confirm correct placement via hydrodissection. Following this, 20 mL of 0.25% bupivacaine (Buvasin® 0.5%, VEM, Tekirdağ, Turkey) was injected incrementally, with aspiration performed every 5 mL. Proper spread of the local anesthetic was confirmed by ultrasound visualization of a hypoechoic distribution between the fascial planes. |
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Active Comparator: PENG Block Group
In the PENG (Pericapsular Nerve Group) block group, patients will be positioned supine, and the block will be performed under ultrasound guidance.
|
In the PENG group, patients were placed in the supine position.
A convex ultrasound probe was positioned under sterile conditions on the operated side, aligned with the iliac bone below the anterior superior iliac spine (ASIS).
The anterior inferior iliac spine (AIIS), iliopubic eminence (IPE), iliopsoas muscle, and its tendon were identified.
Using an in-plane technique, a 22G 100-mm peripheral block needle was advanced toward the IPE, targeting the space between the iliopsoas muscle tendon and the IPE.
Proper placement was confirmed via hydrodissection.
Subsequently, 20 mL of 0.25% bupivacaine was administered slowly, with aspiration performed every 5 mL to avoid intravascular injection.
The correct spread of the local anesthetic was verified via ultrasound, confirming elevation of the iliopsoas tendon.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total Opioid Consumption
Time Frame: 48 hour
|
Total Opioid Consumption
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48 hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adverse Events
Time Frame: 48 hour
|
Monitoring for complications or side effects related to the nerve blocks
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48 hour
|
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Numerical Rating Scale (NRS) Scores
Time Frame: 48 hour
|
Assessed at various time points to quantify pain intensity at rest and during movement.
The Numerical Rating Scale (NRS) is a pain assessment tool where patients rate their pain from 0 (no pain) to 10 (worst pain).
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48 hour
|
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Time to First Rescue Analgesic
Time Frame: 48 hours
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Duration from the end of surgery to the first request for analgesic medication.
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48 hours
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Collaborators and Investigators
Publications and helpful links
General Publications
- Farag A, Hendi NI, Diab RA. Does pericapsular nerve group block have limited analgesia at the initial post-operative period? Systematic review and meta-analysis. J Anesth. 2023 Feb;37(1):138-153. doi: 10.1007/s00540-022-03129-5. Epub 2022 Nov 7.
- Stuart Green M, Ryan Hoffman C, Iqbal U, Olabisi Ives O, Hurd B. Transmuscular Quadratus Lumborum Block Reduces Length of Stay in Patients Receiving Total Hip Arthroplasty. Anesth Pain Med. 2018 Nov 20;8(6):e80233. doi: 10.5812/aapm.80233. eCollection 2018 Dec.
- Zheng J, Pan D, Zheng B, Ruan X. Preoperative pericapsular nerve group (PENG) block for total hip arthroplasty: a randomized, placebo-controlled trial. Reg Anesth Pain Med. 2022 Mar;47(3):155-160. doi: 10.1136/rapm-2021-103228. Epub 2021 Dec 6.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GaziosmanpasaTREH-PENG
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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