Degenerative Lumbar Spine Diseases, Postoperative Pain, Spinal Fusion Surgery
Conditions
Keywords
TLIP Block, Retrolaminar Block, Regional Anesthesia, Quality of Recovery, QoR-15, Lumbar Spine Surgery, Postoperative Analgesia
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.
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
Ultrasound-guided injection of local anesthetic into the fascial plane between the multifidus and longissimus muscles at the L3 level
PROCEDURERetrolaminar block
Ultrasound-guided injection of local anesthetic posterior to the vertebral lamina at the L3 level.
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
Intervention model description
Participants will be randomly assigned to one of two parallel groups: TLIP block group or retrolaminar block group.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Recovery-15 (QoR-15) score at 24 hours postoperatively | 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
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity using Visual Analog Scale (VAS) | 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 to first rescue analgesia | Within 24 hours postoperatively | Time from the end of surgery to the first request for rescue analgesia (VAS ≥ 4). |
| Total nalbuphine consumption | 24 hours postoperatively | Total amount of nalbuphine administered within the first 24 hours after surgery (mg). |
| 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 | — |
| Length of hospital stay | From surgery until hospital discharge, assessed up to 7 days postoperatively | — |
| Incidence of postoperative complications | Within 24-48 hours postoperatively | Includes nausea, vomiting, pruritus, hypotension, bradycardia, hematoma, infection, and local anesthetic systemic toxicity (LAST). |
Countries
Egypt
Contacts
CONTACTRehab Mohamed Mostafa Mahmoud, MD (Candidate)
CONTACTMohamed Abo Elhassan, MD (candidate)
Outcome results
None listed