NCT07448987

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 26, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 4, 2026

Completed
Last Updated

March 4, 2026

Status Verified

February 1, 2026

Enrollment Period

1.2 years

First QC Date

February 26, 2026

Last Update Submit

February 26, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Total morphine consumption

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

    24 hours postoperatively

Secondary Outcomes (4)

  • 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

Study Arms (3)

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).

Other: Quadratus lumborum block

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).

Other: Thoracolumbar interfascial plane block

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).

Other: Local anesthetic infiltration

Interventions

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).

Group I: QLB 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).

Group II: TLIP block 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).

Group III: Local wound infiltration group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident of Anesthesia, Surgical Intensive Care and Pain Management, Tanta University, Tanta, Egypt.

Study Record Dates

First Submitted

February 26, 2026

First Posted

March 4, 2026

Study Start

July 1, 2024

Primary Completion

August 30, 2025

Study Completion

August 30, 2025

Last Updated

March 4, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Shared Documents
STUDY PROTOCOL
Time Frame
After the end of study for one year.
Access Criteria
The data will be available upon a reasonable request from the corresponding author.

Locations