TLIP Block Versus Retrolaminar Block on Quality of Recovery After Posterior Lumbar Spine Fusion Surgery (TLIP-RLB-QoR)
Thoracolumbar Interfascial Plane Block Versus Retrolaminar Block on Quality of Recovery After Posterior Lumbar Spine Fusion Surgery: A Prospective Randomized Controlled Trial
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.
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Rehab Mohamed Mostafa Mahmoud, MD (Candidate)
- Telefoonnummer: +201063303791
- E-mail: rehab.mohamed19@gmail.com
Studie Contact Back-up
- Naam: Mohamed Abo Elhassan, MD (candidate)
- Telefoonnummer: +201001311044
- E-mail: Aboelhassan@gmail.com
Studie Locaties
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Asyut, Egypte
- Assiut University Hospitals
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Thoracolumbar interfascial plane Block Group
Patients will receive ultrasound-guided thoracolumbar interfascial plane block after induction of general anesthesia.
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Ultrasound-guided injection of local anesthetic into the fascial plane between the multifidus and longissimus muscles at the L3 level
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Experimenteel: Retrolaminar Block Group
Patients will receive ultrasound-guided retrolaminar block after induction of general anesthesia.
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Ultrasound-guided injection of local anesthetic posterior to the vertebral lamina at the L3 level.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Quality of Recovery-15 (QoR-15) score at 24 hours postoperatively
Tijdsspanne: 24 hours postoperatively
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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.
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24 hours postoperatively
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Pain intensity using Visual Analog Scale (VAS)
Tijdsspanne: 30 minutes, 2, 6, 12, and 24 hours postoperatively
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Pain will be assessed using a 0-10 Visual Analog Scale, where 0 indicates no pain and 10 indicates worst imaginable pain.
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30 minutes, 2, 6, 12, and 24 hours postoperatively
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Time to first rescue analgesia
Tijdsspanne: Within 24 hours postoperatively
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Time from the end of surgery to the first request for rescue analgesia (VAS ≥ 4).
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Within 24 hours postoperatively
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Total nalbuphine consumption
Tijdsspanne: 24 hours postoperatively
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Total amount of nalbuphine administered within the first 24 hours after surgery (mg).
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24 hours postoperatively
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Time to first ambulation
Tijdsspanne: From end of surgery to first ambulation, assessed up to 48 hours postoperatively
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From end of surgery to first ambulation, assessed up to 48 hours postoperatively
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Time to tolerate oral intake
Tijdsspanne: From end of surgery to first tolerated oral intake, assessed up to 48 hours postoperatively
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From end of surgery to first tolerated oral intake, assessed up to 48 hours postoperatively
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Length of hospital stay
Tijdsspanne: From surgery until hospital discharge, assessed up to 7 days postoperatively
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From surgery until hospital discharge, assessed up to 7 days postoperatively
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Incidence of postoperative complications
Tijdsspanne: Within 24-48 hours postoperatively
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Includes nausea, vomiting, pruritus, hypotension, bradycardia, hematoma, infection, and local anesthetic systemic toxicity (LAST).
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Within 24-48 hours postoperatively
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Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
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Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
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Eerst ingediend dat voldeed aan de QC-criteria
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Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- TLIP-RLB-QoR-2026
Plan Individuele Deelnemersgegevens (IPD)
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