- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07815145
Quadroiliac Plane Block Versus Transmuscular Quadratus Lumborum Block for Postoperative Analgesia After Total Hip Arthroplasty
Quadroiliac Plane Block Versus Transmuscular Quadratus Lumborum Block for Postoperative Analgesia After Total Hip Arthroplasty: A Randomized Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Total hip arthroplasty (THA) is a common orthopedic procedure for end-stage hip diseases such as osteoarthritis and avascular necrosis. It is highly effective in relieving pain and restoring function.
The quadratus lumborum block (QLB) is one such fascial plane technique. It provides analgesia through spread of local anesthetics within the thoracolumbar fascia. This allows potential involvement of lumbar plexus branches.
The Quadroiliac Plane Block (QIPB) is a newer regional technique for hip and pelvic surgery. It targets fascial planes near the iliac region to block sensory innervation of the hip. Early studies suggest it may provide effective postoperative analgesia.
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 18-75 years.
- Both sexes.
- American Society of Anesthesiologists (ASA) classification I-III.
- Scheduled for elective primary unilateral total hip arthroplasty under spinal anesthesia.
Exclusion Criteria:
- Allergy to local anesthetics.
- Infection at the injection site.
- Coagulopathy or bleeding disorders.
- Neuromuscular disorders.
- Chronic opioid use or dependence.
- Body mass index (BMI) > 40 kg/m².
- Severe cardiac, hepatic, renal, or respiratory dysfunction.
- Contraindication to regional anesthesia.
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 QIP
Patients will receive an ultrasound-guided Quadroiliac Plane Block (QIPB) using 20 mL of bupivacaine 0.25%.
|
Patients will receive an ultrasound-guided Quadroiliac Plane Block (QIPB) using 20 mL of bupivacaine 0.25%.
|
|
Experimental: Group QLB
Patients will receive ultrasound-guided quadratus lumborum block (QLB) (transmuscular approach) using 20 mL of 0.25% bupivacaine.
|
Patients will receive ultrasound-guided quadratus lumborum block (QLB) (transmuscular approach) using 20 mL of 0.25% bupivacaine.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total morphine consumption
Time Frame: 24 hours postoperatively
|
Rescue analgesia of morphine will be given as 3 mg bolus if the numeric rating scale (NRS) > 3 to be repeated after 30 min if pain persists until the NRS < 4.
|
24 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
|
|
Degree of pain
Time Frame: 24 hours postoperatively
|
Each patient will be instructed about postoperative pain assessment with the numeric rating scale (NRS) score.
NRS (0 represents "no pain" while 10 represents "the worst pain imaginable").
NRS will be assessed at post-anesthesia care unit (PACU), 2, 4, 6, 12, and 24 h postoperatively.
|
24 hours postoperatively
|
|
Time to the 1st rescue analgesia
Time Frame: 24 hours postoperatively
|
Time to the first request for rescue analgesia will be recorded from the end of block to first dose of morphine administrated.
|
24 hours postoperatively
|
|
Time for ambulation
Time Frame: 24 hours postoperatively
|
Time to ambulation: the time interval (in hours) 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.
|
24 hours postoperatively
|
|
Length of hospital stay
Time Frame: Till the discharge from hospital (Up to 2 weeks)
|
Length of hospital stay will be recorded from admission till the discharge from hospital.
|
Till the discharge from 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
Other Study ID Numbers
- 36265PR152/7/26
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
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