NCT07609212

Brief Summary

This prospective randomized controlled study aims to compare the effects of ultrasound-guided thoracolumbar interfascial plane (TLIP) block versus retrolaminar block on postoperative quality of recovery in patients undergoing posterior lumbar spine fusion surgery. Despite advances in surgical techniques, lumbar spine fusion is associated with significant postoperative pain, which may delay recovery and increase opioid consumption. Recent approaches emphasize multimodal analgesia and opioid-sparing strategies, including regional anesthesia techniques. Interfascial plane blocks, such as TLIP and retrolaminar block, have gained attention due to their safety and effectiveness in targeting the dorsal rami of spinal nerves supplying the posterior spinal structures. The primary outcome of this study is postoperative quality of recovery assessed using the Quality of Recovery-15 (QoR-15) questionnaire at 24 hours. Secondary outcomes include pain scores, opioid consumption, time to ambulation, time to oral intake, and postoperative complications.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable postoperative-pain

Timeline
12mo left

Started Jun 2026

Geographic Reach
1 country

1 active site

Status
not yet 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 Progress4%
Jun 2026Jun 2027

First Submitted

Initial submission to the registry

April 20, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 27, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

May 27, 2026

Status Verified

May 1, 2026

Enrollment Period

1 year

First QC Date

April 20, 2026

Last Update Submit

May 21, 2026

Conditions

Keywords

TLIP BlockRetrolaminar BlockRegional AnesthesiaQuality of RecoveryQoR-15Lumbar Spine SurgeryPostoperative Analgesia

Outcome Measures

Primary Outcomes (1)

  • Quality of Recovery-15 (QoR-15) score at 24 hours postoperatively

    Quality of recovery will be assessed using the Quality of Recovery-15 (QoR-15) questionnaire, a validated 15-item patient-reported outcome measure. Scores range from 0 to 150, with higher scores indicating better postoperative recovery. The primary endpoint is the QoR-15 score at 24 hours after surgery.

    24 hours postoperatively

Secondary Outcomes (7)

  • Pain intensity using Visual Analog Scale (VAS)

    30 minutes, 2, 6, 12, and 24 hours postoperatively

  • Time to first rescue analgesia

    Within 24 hours postoperatively

  • Total nalbuphine consumption

    24 hours postoperatively

  • Time to first ambulation

    From end of surgery to first ambulation, assessed up to 48 hours postoperatively

  • Time to tolerate oral intake

    From end of surgery to first tolerated oral intake, assessed up to 48 hours postoperatively

  • +2 more secondary outcomes

Study Arms (2)

Thoracolumbar interfascial plane Block Group

EXPERIMENTAL

Patients will receive ultrasound-guided thoracolumbar interfascial plane block after induction of general anesthesia.

Procedure: Thoracolumbar interfascial plane block

Retrolaminar Block Group

EXPERIMENTAL

Patients will receive ultrasound-guided retrolaminar block after induction of general anesthesia.

Procedure: Retrolaminar block

Interventions

Ultrasound-guided injection of local anesthetic posterior to the vertebral lamina at the L3 level.

Retrolaminar Block Group

Ultrasound-guided injection of local anesthetic into the fascial plane between the multifidus and longissimus muscles at the L3 level

Thoracolumbar interfascial plane Block Group

Eligibility Criteria

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

You may qualify if:

  • Adult patients aged 18-65 years
  • Male and female patients
  • Scheduled for elective one- or two-level posterior lumbar instrumented fusion surgery under general anesthesia
  • ASA physical status I-III
  • BMI \< 35 kg/m²
  • Willing to participate and provide informed consent

You may not qualify if:

  • Patient refusal to participate
  • Coagulopathy or anticoagulant therapy
  • Infection at the site of block injection
  • Known allergy to local anesthetics
  • Chronic opioid use (\>3 months)
  • Severe hepatic, renal, or cardiac dysfunction
  • Neurological deficits interfering with pain assessment
  • Pregnancy or lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University Hospitals

Asyut, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Central Study Contacts

Rehab Mohamed Mostafa Mahmoud, MD (Candidate)

CONTACT

Mohamed Abo Elhassan, MD (candidate)

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
This is a double-blind study where participants and outcome assessors are blinded to group allocation. The anesthesiologist performing the block is not blinded. Identical dressings are applied to maintain blinding.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to one of two parallel groups: TLIP block group or retrolaminar block group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer of Anesthesia, Intensive Care, and Pain Management

Study Record Dates

First Submitted

April 20, 2026

First Posted

May 27, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

May 27, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations