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NCT Number: NCT07609212

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assiut University Hospitals

Asyut, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Thoracolumbar interfascial plane block

Procedure

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

retrolaminar block

Procedure

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

Primary outcomes

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

    Time frame: 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.

Secondary outcomes

  1. Pain intensity using Visual Analog Scale (VAS)

    Time frame: 30 minutes, 2, 6, 12, and 24 hours postoperatively

    Pain will be assessed using a 0-10 Visual Analog Scale, where 0 indicates no pain and 10 indicates worst imaginable pain.

  2. Time to first rescue analgesia

    Time frame: Within 24 hours postoperatively

    Time from the end of surgery to the first request for rescue analgesia (VAS ≥ 4).

  3. Total nalbuphine consumption

    Time frame: 24 hours postoperatively

    Total amount of nalbuphine administered within the first 24 hours after surgery (mg).

  4. Time to first ambulation

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

  5. Time to tolerate oral intake

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

  6. Length of hospital stay

    Time frame: From surgery until hospital discharge, assessed up to 7 days postoperatively

  7. Incidence of postoperative complications

    Time frame: Within 24-48 hours postoperatively

    Includes nausea, vomiting, pruritus, hypotension, bradycardia, hematoma, infection, and local anesthetic systemic toxicity (LAST).

Study contacts

Contact information is provided by the study sponsor or research team.

Mohamed Abo Elhassan, MD (candidate)

CONTACT

[email protected]

+201001311044

Rehab Mohamed Mostafa Mahmoud, MD (Candidate)

CONTACT

[email protected]

+201063303791

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Acronym: TLIP-RLB-QoR

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 27, 2026
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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