Assiut University Hospitals
Asyut, Egypt
NCT Number: NCT07609212
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 opening soon.
Get Notified18 year–65 year
All sexes
Interventional
Not applicable
Asyut, Egypt
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Ultrasound-guided injection of local anesthetic into the fascial plane between the multifidus and longissimus muscles at the L3 level
Ultrasound-guided injection of local anesthetic posterior to the vertebral lamina at the L3 level.
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.
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.
Time frame: Within 24 hours postoperatively
Time from the end of surgery to the first request for rescue analgesia (VAS ≥ 4).
Time frame: 24 hours postoperatively
Total amount of nalbuphine administered within the first 24 hours after surgery (mg).
Time frame: From end of surgery to first ambulation, assessed up to 48 hours postoperatively
Time frame: From end of surgery to first tolerated oral intake, assessed up to 48 hours postoperatively
Time frame: From surgery until hospital discharge, assessed up to 7 days postoperatively
Time frame: Within 24-48 hours postoperatively
Includes nausea, vomiting, pruritus, hypotension, bradycardia, hematoma, infection, and local anesthetic systemic toxicity (LAST).
Contact information is provided by the study sponsor or research team.
Mohamed Abo Elhassan, MD (candidate)
CONTACT
Rehab Mohamed Mostafa Mahmoud, MD (Candidate)
CONTACT
Assiut University
Other
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
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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