- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07606794
Supra-Iliac Anterior Quadratus Lumborum Block and Pericapsular Nerve Group (PENG) Block for Analgesia After Total Hip Arthroplasty
A Randomized Clinical Non-Inferiority Trial Comparing Supra-Iliac Anterior Quadratus Lumborum Block and Pericapsular Nerve Group (PENG) Block for Analgesia After Total Hip Arthroplasty
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Total hip arthroplasty (THA) is one of the most common elective orthopedic procedures, performed to restore mobility, alleviate pain and improve quality of life in patients with degenerative hip joint disease. Its rate is projected to further increase with aging of the population worldwide.
Pericapsular nerve group (PENG) block is a fascial block targets periarticular sensory branches derived from the femoral, obturator and accessory obturator nerves innervating the anterior hip capsule.
The ultrasound-guided quadratus lumborum block (QLB) is a regional anesthetic technique with many described approaches: the lateral QL (QL1) block, the posterior QL (QL2) block, and the anterior QL (transmuscular) block.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mohammed S Elsharkawy, MD
- Phone Number: 00201148207870
- Email: mselsharkawy@med.tanta.edu.eg
Study Locations
-
-
El-Gharbia
-
Tanta, El-Gharbia, Egypt, 31527
- Tanta University
-
Contact:
- Mohammed S Elsharkawy, MD
- Phone Number: 00201148207870
- Email: mselsharkawy@med.tanta.edu.eg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age from 18 to 75 years.
- Both sexes.
- American Society of Anesthesiologists (ASA) classification I-III.
- Scheduled for primary elective unilateral total hip arthroplasty (THA) under spinal anesthesia.
Exclusion Criteria:
- Known allergies to the drugs used.
- Infection at the injection site.
- Bleeding disorders.
- Recognized neuromuscular disorders.
- Opioid addiction or dependence.
- Contraindications to regional anesthesia or peripheral nerve blockade.
- Body mass index (BMI) > 40 kg/m².
- Associated decompensated cardiac, hepatic, respiratory, or renal diseases.
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 |
|---|---|
|
Experimental: Group SA- QLB
Patients will receive a supra-iliac anterior quadratus lumborum block (SA-QLB) using 20mL of bupivacaine 0.25%.
|
Patients will receive a supra-iliac anterior quadratus lumborum block (SA-QLB) using 20mL of bupivacaine 0.25%.
|
|
Experimental: Group PENG
Patients will receive an ultrasound-guided pericapsular nerve group (PENG) block using 20mL of bupivacaine 0.25%.
|
Patients will receive an ultrasound-guided pericapsular nerve group (PENG) block using 20mL of bupivacaine 0.25%.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Degree of pain
Time Frame: 12 hours postoperatively
|
Each patient will be instructed about postoperative pain assessment with visual analog scale (VAS).
VAS (0 represents "no pain" while 10 represents "the worst pain imaginable")
|
12 hours postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of adverse events
Time Frame: 24 hours postoperatively
|
Incidence of adverse events such as bradycardia, hypotension, nausea, vomiting, respiratory depression, or any other complication will be recorded.
|
24 hours postoperatively
|
|
Total morphine consumption
Time Frame: 48 hours postoperatively
|
Rescue analgesia of morphine will be given as 3 mg bolus if the VAS > 3 to be repeated after 30 min if pain persists until the visual analog scale (VAS) < 4. VAS will be assessed at post-anesthesia care unit (PACU), 2, 4, 6, 12, 24, and 48 h postoperatively.
|
48 hours postoperatively
|
|
Time to the first rescue analgesia
Time Frame: 48 hours postoperatively
|
Time to the first request for the rescue analgesia will be recorded from the end of block to first dose of morphine administrated.
|
48 hours postoperatively
|
|
Time to ambulation
Time Frame: Till the first successful mobilization (Up to 4 hours)
|
Time to ambulation will be recorded from the end of surgery to the first successful mobilization of the patient, defined as the ability to stand and walk at least 3-5 steps with or without assistance.
|
Till the first successful mobilization (Up to 4 hours)
|
|
Length of hospital stay
Time Frame: Till discharge from the hospital (Up to 2 weeks)
|
Length of hospital stay will be recorded from admission till the discharge from hospital.
|
Till discharge from the hospital (Up to 2 weeks)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 36265PR1/4/26
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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