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Not yet recruiting NCT07609212

TLIP Block Versus Retrolaminar Block on Quality of Recovery After Posterior Lumbar Spine Fusion Surgery

No phase Interventional Postoperative Pain Spinal Fusion Surgery Degenerative Lumbar Spine Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Thoracolumbar interfascial plane block, Retrolaminar block.
Who it may be relevant to
Registry conditions: Postoperative Pain, Spinal Fusion Surgery, Degenerative Lumbar Spine Diseases. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Thoracolumbar Interfascial Plane Block Versus Retrolaminar Block on Quality of Recovery After Posterior Lumbar Spine Fusion Surgery: A Prospective Randomized Controlled Trial

Overview

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.

Detailed description

This study is a prospective, randomized, controlled, double-blind clinical trial conducted at Assiut University Hospital. A total of 70 adult patients scheduled for elective one- or two-level posterior lumbar instrumented fusion surgery under general anesthesia will be enrolled and randomly allocated into two equal groups.

Patients in Group T will receive ultrasound-guided thoracolumbar interfascial plane (TLIP) block, while patients in Group R will receive ultrasound-guided retrolaminar block. All blocks will be performed after induction of general anesthesia under strict aseptic precautions by an experienced anesthesiologist.

Randomization will be performed using a computer-generated sequence with allocation concealment via sequentially numbered, opaque, sealed envelopes. The study will be conducted in a double-blind manner, where patients and outcome assessors will be blinded to group allocation.

All patients will receive standardized perioperative care based on enhanced recovery principles, including multimodal analgesia and early mobilization. Postoperative pain will be assessed using the Visual Analog Scale (VAS), and rescue analgesia will be administered when needed.

The primary outcome is the QoR-15 score at 24 hours postoperatively. Secondary outcomes include pain scores at predefined intervals, time to first rescue analgesia, total opioid consumption, time to ambulation, time to oral intake, length of hospital stay, and incidence of postoperative complications.

Interventions

  • Procedure Thoracolumbar interfascial plane block
    Ultrasound-guided injection of local anesthetic into the fascial plane between the multifidus and longissimus muscles at the L3 level
  • Procedure Retrolaminar block
    Ultrasound-guided injection of local anesthetic posterior to the vertebral lamina at the L3 level.

Primary outcome measures

  • Quality of Recovery-15 (QoR-15) score at 24 hours postoperatively [Time frame: 24 hours postoperatively]
Secondary outcome measures (7)
  • Pain intensity using Visual Analog Scale (VAS) [Time frame: 30 minutes, 2, 6, 12, and 24 hours postoperatively]
  • Time to first rescue analgesia [Time frame: Within 24 hours postoperatively]
  • Total nalbuphine consumption [Time frame: 24 hours postoperatively]
  • Time to first ambulation [Time frame: From end of surgery to first ambulation, assessed up to 48 hours postoperatively]
  • Time to tolerate oral intake [Time frame: From end of surgery to first tolerated oral intake, assessed up to 48 hours postoperatively]
  • Length of hospital stay [Time frame: From surgery until hospital discharge, assessed up to 7 days postoperatively]
  • Incidence of postoperative complications [Time frame: Within 24-48 hours postoperatively]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Assiut University Hospitals — Asyut

Identifiers

NCT: NCT07609212 · TLIP-RLB-QoR-2026

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗