- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07448987
Ultrasound Guided Quadratus Lumborum Block, Thoracolumbar Interfascial Plane Block, and Local Anesthetic Infiltration for Lumbar Spine Fixation
Comparison of The Efficacy of Ultrasound Guided Quadratus Lumborum Block, Thoracolumbar Interfascial Plane Block, and Local Anesthetic Infiltration for Lumbar Spine Fixation: Prospective Randomized Trial
Study Overview
Status
Conditions
Detailed Description
Back and leg pain arising from lumbar spine surgery is widespread, and its treatment can range from pharmacotherapy to surgical intervention. A majority of patients who undergo spinal surgery report experiencing moderate pain six months after the operation.
Interfascial plane blocks, including the thoracolumbar interfascial plane (TLIP) block target these posterior rami passing through the paraspinal muscles. Several studies have explored the analgesic efficacy of TLIP block in posterior lumbar spine surgery.
Quadratus lumborum block (QLB) is a posterior abdominal wall fascial block where local anesthetic is administered around QL muscle. play a significant role in contemporary medical practice for enhancing post-spinal surgery pain management.
Local infiltrative analgesia applied in layers of the surgical wound layers has been suggested as an appealing alternative due to its simplicity, enhanced safety, and limited cost, also a popular modality for postoperative analgesia in spine surgery.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
El-Gharbia
-
Tanta, El-Gharbia, Egypt, 31527
- Tanta University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age from 18 to 65 years.
- Both genders.
- American Society of Anesthesiology (ASA) class I - II.
- Scheduled for elective lumbar spine fixation up to three level.
Exclusion Criteria:
- Patient refusal.
- History of allergy to local anesthetic.
- Mental dysfunction or cognitive disorders.
- Body Mass Index > 30 kg/m2.
- Coagulopathy.
- Pregnancy.
- Infections to the site of the block.
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 I: QLB group
Patients received general anesthesia and bilateral ultrasound guided trans-muscular quadratus lumborum block (QLB 3) with (20 ml Bupivacaine 0.25% each side) + (Dexmedetomidine 0.5 mic/kg) for each side as total volume (1 mic/kg).
|
Patients received general anesthesia and bilateral ultrasound guided trans-muscular quadratus lumborum block (QLB 3) with (20 ml Bupivacaine 0.25% each side) + (Dexmedetomidine 0.5 mic/kg) for each side as total volume (1 mic/kg).
|
|
Experimental: Group II: TLIP block group
Patients received general anesthesia and bilateral ultrasound guided thoracolumbar interfascial plane block with (20ml of Bupivacaine 0.25%) for each side + (Dexmedetomidine 0.5 mic/kg) for each side as total volume (1 mic/kg).
|
Patients received general anesthesia and bilateral ultrasound guided thoracolumbar interfascial plane block with (20ml of Bupivacaine 0.25%) for each side + (Dexmedetomidine 0.5 mic/kg) for each side as total volume (1 mic/kg).
|
|
Experimental: Group III: Local wound infiltration group
Patients received general anesthesia and local anesthetic infiltration at the side of incision before with (40 ml of Bupivacaine 0.25%) + (Dexmedetomidine 1mic/kg).
|
Patients received general anesthesia and local anesthetic infiltration at the side of incision before with (40 ml of Bupivacaine 0.25%) + (Dexmedetomidine 1mic/kg).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total morphine consumption
Time Frame: 24 hours postoperatively
|
Intravenous morphine (0.05mg/kg) was given when numeric rating scale (NRS) equal or above 4.
|
24 hours postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean arterial pressure
Time Frame: Till end of surgery (Up to 2 hours)
|
Mean arterial pressure was recorded before induction of anesthesia (base-line value), after prone position, at the time of skin incision and after skin incision by 5,15 and 30 minutes, and at the end of the operation.
|
Till end of surgery (Up to 2 hours)
|
|
Heart rate
Time Frame: Till end of surgery (Up to 2 hours)
|
Heart rate was recorded before induction of anesthesia (base-line value), after prone position, at the time of skin incision and after skin incision by 5,15 and 30 minutes, and at the end of the operation.
|
Till end of surgery (Up to 2 hours)
|
|
Time to the first request for rescue analgesia
Time Frame: 24 hours postoperatively
|
Time to the first request for rescue analgesia was recorded from the end of surgery till first dose of morphine administrated.
|
24 hours postoperatively
|
|
Degree of pain
Time Frame: 24 hours postoperatively
|
Each patient was 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 were the 0th (PACU), 1th, 3rd, 6th, 12th, and 24th postoperative hours.
|
24 hours postoperatively
|
Collaborators and Investigators
Sponsor
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
Other Study ID Numbers
- 36264MS646/7/24
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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