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.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Rehab Mohamed Mostafa Mahmoud, MD (Candidate)
- 전화번호: +201063303791
- 이메일: rehab.mohamed19@gmail.com
연구 연락처 백업
- 이름: Mohamed Abo Elhassan, MD (candidate)
- 전화번호: +201001311044
- 이메일: Aboelhassan@gmail.com
연구 장소
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Asyut, 이집트
- Assiut University Hospitals
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Quality of Recovery-15 (QoR-15) score at 24 hours postoperatively
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Pain intensity using Visual Analog Scale (VAS)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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