NCT07517822

Brief Summary

The aim of this study is to compare postoperative analgesia and duration for each block performance plus complications after surgery in lumbar spine fixation.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Dec 2025

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

December 1, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 2, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 8, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Completed
Last Updated

April 8, 2026

Status Verified

April 1, 2026

Enrollment Period

6 months

First QC Date

April 2, 2026

Last Update Submit

April 2, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Comparison between postoperative analgesia of QLB and ESPB after lumbar spine surgery via VAS score measurement

    The Visual Analog Scale (VAS) is used to assess pain intensity. It consists of a 10 cm line where 0 indicates "no pain" and 10 indicates "the worst possible pain." Higher scores indicate greater pain intensity.

    VAS Score will be used to assess pain or discomfort in postoperative at 2, 4, 6, 12, 24 hours

Study Arms (2)

Ultrasound-guided quadratus lumborum block

ACTIVE COMPARATOR
Procedure: Ultrasound-guided quadratus lumborum block (QLB)

Ultrasound Guided Erector Spinae Plane Block (ESPB)

ACTIVE COMPARATOR
Procedure: Ultrasound-guided quadratus lumborum block (QLB)

Interventions

And ultrasound guided QLB block with transmuscular approach was performed using 0.5 ml/kg 0.25% bupivacaine to the patients in QLB group

Ultrasound Guided Erector Spinae Plane Block (ESPB)Ultrasound-guided quadratus lumborum block

Eligibility Criteria

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

You may qualify if:

  • Aged between 18 and 65 years.
  • American Society of Anesthesiologists (ASA) physical status I to II.
  • Body mass index (BMI) less than 35 kg/m2.

You may not qualify if:

  • Revision surgery.
  • More than three levels surgery.
  • Abnormal state of blood coagulation.
  • Chronic opioid consumption.
  • Local infection at the injection site).
  • Allergy to any involved medications.
  • Taking opioids within the past two weeks prior to surgery.
  • Time of surgery more than 4 hours.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AinShamsU

Cairo, Cairo Governorate, 11511, Egypt

Location

Related Publications (1)

  • Fakhry, Mahmoud, D., ElMoutaz Mahmoud, H., Yehia Kassim, D. & NegmEldeen AbdElAzeem, H. 2024. Erector spinae plane block versus quadratus lumborum block for postoperative analgesia after laparoscopic resection of colorectal cancer: A prospective randomized study. Anesthesiol Res Pract, 20, 10.

    BACKGROUND

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2026

First Posted

April 8, 2026

Study Start

December 1, 2025

Primary Completion

June 1, 2026

Study Completion

July 1, 2026

Last Updated

April 8, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

To maintain participant confidentiality and because there is no established institutional repository for sharing raw individual participant data for this specific project.

Locations