- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05600244
PENG vs. QLB vs. Lumbar ESPB in Total Hip Surgery
Comparison of Pericapsular Nerve Group Block, Quadratus Lumborum Block and Lumbar Erector Spinae Plane Block for Acute Pain Management in Total Hip Surgery: A Randomized Clinical Trial
Study Overview
Status
Detailed Description
Total hip surgeries are one of the most common major orthopedic procedures to improve patient's functional status and quality of life. However, despite these advantages, the immediate postoperative period can be associated with severe pain that delays mobilization and increases hospital stay and the risk of thromboembolic events.
Various methods are used for postoperative pain management. Intravenous opioid agents are among them, but they may cause undesirable side effects, such as respiratory depression, sedation, constipation, allergic reaction, nausea, and vomiting. Thus, alternative techniques are preferred.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mohammad F. Algyar, MD
- Phone Number: +20 111645345
- Email: mohammad.algaiar@med.kfs.edu.eg
Study Locations
-
-
ElGharbiaa
-
Tanta, ElGharbiaa, Egypt, 31511
- Recruiting
- Mohammad Fouad Algyar
-
Contact:
- Mohammad F Algyar, MD
- Phone Number: 00201111645345
- Email: mohammad.algaiar@med.kfs.edu.eg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 18-65 years
- Both genders
- Body mass index < 40 kg/m^2
- American Society of Anesthesiologists (ASA) physical status I-III
- Posted for total hip surgeries under spinal anesthesia
Exclusion Criteria:
- The presence of contraindications or allergy to local anesthetic agents
- Chronic use of opioids or corticosteroids
- Infection at the puncture site
- Coagulopathy
- Psychiatric disorders (dementia or cognitive impairment.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: PENG block Technique
Patients will receive ultrasound-guided Pericapsular Nerve Group Block using 30 ml bupivacaine 0.25%.
|
A linear probe will be used.
Puncture will be performed in a lateromedial direction until the needle tip reached the plane between the iliopsoas tendon and periosteum and between the anterior inferior iliac spine and iliopubic eminence.
After a negative aspiration test, 30 ml of bupivacaine 0.25% will be injected in the plane beneath the iliopsoas muscle
|
|
Experimental: Lumbar ESPB Technique
Patients will receive lumbar erector spinae plane block using 30 ml bupivacaine 0.25%
|
Using the out-plane technique, a 22G/80-mm block needle will be advanced until it reached the transverse process.
0.5-1 ml of the prepared local anesthetic solution, 30 ml bupivacaine 0.25% will be administered leading to hydrodissection to confirm the correct location.
The needle will be repositioned by pulling back a few millimeters if resistance occurs when administering local anesthetic .
All local anesthetic will be administered to this location between the transverse process and the erector spinae muscle
|
|
Experimental: Transmuscular QLB-t block Technique
Patients will receive transmuscular quadratus lumborum block using 30 ml bupivacaine 0.25%
|
A convex transducer will be placed in the transverse plane on the flank of the patient cranial to the iliac crest.
The 4th lumbar vertebral transverse process, erector spinae muscles, psoas muscle, transverse abdominis muscle, internal and externa oblique muscles, and the quadratus lumborum muscle will be identified.
A 15 cm 22G insulated needle will be inserted on the posterior corner of the transducer.
30 ml bupivacaine 0.25% will be administered between the quadratus lumborum and psoas muscles into the fascial plane.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total amount of rescue analgesia
Time Frame: 24 hours postoperatively
|
Total amount of rescue analgesia in the form of morphine will be recorded
|
24 hours postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
First analgesic request
Time Frame: 24 hours Postoperatively
|
The time to first request of rescue analgesia will be recorded
|
24 hours Postoperatively
|
|
Pain level
Time Frame: 48 hours Postoperatively
|
Pain level will be evaluated using numeric rating analogue scale (NRS), which ranges from 0 to 10 points, with 0 indicating no pain, 1-3 indicating mild pain, 4-6 indicating moderate pain, and 7-10 indicating severe pain.
|
48 hours Postoperatively
|
|
Adverse events
Time Frame: 48 hours Postoperatively
|
Adverse events will be recorded (e.g., nausea, vomiting, hypotension and bradycardia)
|
48 hours Postoperatively
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
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
- MKSU 50-9-21
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
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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