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Clinical Trials/NCT07448987
NCT07448987
Completed
Not Applicable

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

Tanta University1 site in 1 country75 target enrollmentStarted: July 1, 2024Last updated:

Overview

Phase
Not Applicable
Status
Completed
Enrollment
75
Locations
1
Primary Endpoint
Total morphine consumption

Overview

Brief Summary

This study aimed to compare the efficacy of ultrasound guided trans-muscular quadratus lumborum Block, thoracolumbar interfascial plane block and local anesthetic infiltration for elective lumbar spine fixation undergo up to three-level fixation.

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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/m
  • Coagulopathy.
  • Pregnancy.
  • Infections to the site of the block.

Arms & Interventions

Group I: QLB group

Experimental

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).

Intervention: Quadratus lumborum block (Other)

Group II: TLIP block group

Experimental

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).

Intervention: Thoracolumbar interfascial plane block (Other)

Group III: Local wound infiltration group

Experimental

Patients received general anesthesia and local anesthetic infiltration at the side of incision before with (40 ml of Bupivacaine 0.25%) + (Dexmedetomidine 1mic/kg).

Intervention: Local anesthetic infiltration (Other)

Outcomes

Primary Outcomes

Total morphine consumption

Time Frame: 24 hours postoperatively

Intravenous morphine (0.05mg/kg) was given when numeric rating scale (NRS) equal or above 4.

Secondary Outcomes

  • Mean arterial pressure(Till end of surgery (Up to 2 hours))
  • Heart rate(Till end of surgery (Up to 2 hours))
  • Time to the first request for rescue analgesia(24 hours postoperatively)
  • Degree of pain(24 hours postoperatively)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Adel Fareed Elkot

Resident of Anesthesia, Surgical Intensive Care and Pain Management, Tanta University, Tanta, Egypt.

Tanta University

Study Sites (1)

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