- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05654519
Comparison of Pericapsular Nerve Group Block and Quadratus Lumborum Block
Comparison of Pericapsular Nerve Group Block with Lateral Femoral Cutaneous Nerve Block and Quadratus Lumborum Block for Total Hip Arthroplasty
Adequate pain management following total hip arthroplasty (THA) is a key component for patient satisfaction and early ambulation. However, due to the complexity of the innervation of the hip joint, the most appropriate anaesthetic and analgesic technique for THA remains unclear. A femoral nerve block is commonly performed and well established but is associated with motor weakness. Recently, the pericapsular nerve group (PENG) block has been introduced as an effective choice which targets the articular branches of the hip. The quadratus lumborum block (QLB) is a relatively new regional block that has been reported to provide effective analgesia for THA.
The main objective of this study is to compare the effectiveness of the ultrasound-guided PENG block technique compared to QLB block in terms of efficacy of pain control and the safety profile after total hip arthroplasty under spinal anesthesia.
Study Overview
Status
Intervention / Treatment
Detailed Description
The patients will be randomly classified into two equal groups (40 patients each). Group allocation will be done by computer generated random numbers and closed opaque sealed envelopes. The study will be designed to be double blind as all patients and outcomes assessor will be blinded to group assignment.
Patients will be randomized to one of three equal groups:
Group I (n= 40 patients): Patients in this group will receive an ipsilateral single shot of QLB (30 ml of plain bupivacaine 0.25%) after surgery using ultrasonographic guidance.
Group II(n= 40 patients): patients in this group will receive an ipsilateral single-shot of PENG block (25 ml of plain bupivacaine 0.25%) and LFCN block (5 ml of plain bupivacaine 0.25%) after surgery using ultrasonographic guidance.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Konya, Turkey
- Alper Kilicaslan
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Physical status according to American Society of Anesthesiologists (ASA ) I-III
Exclusion Criteria:
- Younger than 40 years old and older than 85
- Patients undergoing general anesthesia
- Allergy or intolerance to one of the study medications
- Infection of the skin at the site of the needle puncture,
- Patients who do not accept the procedure
- History of bleeding diathesis
- ASA IV,
- Chronic gabapentin/pregabalin,opioid use
- Hepatic or renal insufficiency
- Previous operation on the same hip
- BMI >40
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group QL Block
A convex transducer will be placed in the transverse plane on the flank cranial to the iliac crest to visualise the transverse process of the 4th lumbar vertebra, erector spina, quadratus lumborum and psoas muscles as a 'Shamrock sign'.
The needle will inserted in to the fascial plane between the quadratus lumborum and psoas muscles and 30 ml bupivacaine 0.25% will be administered.
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Bupivacaine 0.25% injection
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Active Comparator: Group PENG+LFCN Block
A linear probe will be placed on the anterior inferior iliac crest in the transverse plane while the patient is in the supine position. After rotating 45 degrees, the pubic ramus, femoral artery and psoas muscle will be visualized. Puncture will be performed in a lateromedial direction until the needle tip reached the plane between the iliopsoas tendon and the iliopubic eminence After a negative aspiration test, 25 ml bupivacaine 0.25% will be injected. Then, the lateral femoral cutaneous nerve (LFCN) block was performed using linear US probe (10-18 MHz).The LFCN will be localized, infero-medially to the antero-superior iliac spine, laterally to the sartorius muscle and 5 ml of bupivacaine 0.25% will be carefully injected. |
Bupivacaine 0.25% injection
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Pain scores
Time Frame: Changes from baseline opioid consumption at postoperative 0, 2, 6, 12 and 24 hours
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Numerical Rating Scale-NRS (0 = no pain and 10 = worst imaginable painranged from 0 to 10)
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Changes from baseline opioid consumption at postoperative 0, 2, 6, 12 and 24 hours
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Opioid consumption
Time Frame: Changes from baseline opioid consumption at postoperative 0, 2, 6, 12 and 24 hours
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Mean opioid consumption in morphine equivalents
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Changes from baseline opioid consumption at postoperative 0, 2, 6, 12 and 24 hours
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Quadriceps muscle strength
Time Frame: Postoperative 24 hours period
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Quadriceps motor function will be tested with the patient supine and with the hip and knee flexed at 45º and 90º, respectively
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Postoperative 24 hours period
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Presence of postoperative nausea, vomiting, pruritus, urinary retention, respiratory depression
Time Frame: Postoperative 24 hours period
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Presence of postoperative nausea, vomiting, pruritus, urinary retention, respiratory depressio
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Postoperative 24 hours period
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Patient satisfaction
Time Frame: Postoperative 24 hours period
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Patients asked whether they would choose the same anaesthetic management in a future operation: Yes/No
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Postoperative 24 hours period
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Collaborators and Investigators
Publications and helpful links
General Publications
- Giron-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.
- Hussain N, Brull R, Speer J, Hu LQ, Sawyer T, McCartney CJL, Abdallah FW. Analgesic benefits of the quadratus lumborum block in total hip arthroplasty: a systematic review and meta-analysis. Anaesthesia. 2022 Oct;77(10):1152-1162. doi: 10.1111/anae.15823. Epub 2022 Aug 10.
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
Other Study ID Numbers
- 2021-541
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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