NCT07166900

Brief Summary

Aim of study The objective of the current study is to compare the efficacy of ultrasound-guided bilateral modified thoracolumbar interfascial plane (TLIP) block versus erector spinae (ES) block in optimizing early quality of recovery (QOR) following lumbar spine surgery under general anesthesia.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P50-P75 for not_applicable low-back-pain

Timeline
Completed

Started Jun 2025

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 11, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

September 11, 2025

Status Verified

September 1, 2025

Enrollment Period

8 months

First QC Date

September 9, 2025

Last Update Submit

September 9, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Quality of Recovery (QOR)

    Assessed using the QOR-15 questionnaire at 24 hours postoperatively

    24 hours postoperatively

Study Arms (2)

Espb

ACTIVE COMPARATOR
Procedure: Modified Thoracolumbar Interfascial Plane Block

Tlib

ACTIVE COMPARATOR
Procedure: Modified Thoracolumbar Interfascial Plane Block

Interventions

The TLIP block, introduced as a modification of the lumbar interfascial plane block, targets the dorsal rami of the thoracolumbar nerves by injecting local anesthetic into the fascial plane between the multifidus and longissimus muscles. This technique is designed to provide analgesia to the posterior elements of the spine, which are often the primary sources of pain after laminectomy

EspbTlib

Eligibility Criteria

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

You may qualify if:

  • Patient scheduled for elective lumbar spine fixation 2-3 levels.
  • American Society of Anesthesiologists(ASA) class I-III.

You may not qualify if:

  • \. Obese patients (Body Mass Index\> 35). 2. Patients with neurological deficits, cardiopulmonary disease, hepatic or renal impairment.
  • \. Patients with history of severe allergies to local anesthetics or other medications used during the procedure.
  • \. Patients with history of coagulation disorder or anticoagulants. 5. Patients with emergency surgeries or re-do surgeries. 6. Patients with systemic infections or infections at the site of injection. 7. Patients with Psychiatric illnesses. 8. Patients with history of drug addiction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fayoum university hospital

Al Fayyum, Egypt

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Md

Study Record Dates

First Submitted

September 9, 2025

First Posted

September 11, 2025

Study Start

June 1, 2025

Primary Completion

February 1, 2026

Study Completion

March 1, 2026

Last Updated

September 11, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations