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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Rehab Mohamed Mostafa Mahmoud, MD (Candidate)
- 電話番号：+201063303791
- メール：rehab.mohamed19@gmail.com
研究連絡先のバックアップ
- 名前：Mohamed Abo Elhassan, MD (candidate)
- 電話番号：+201001311044
- メール：Aboelhassan@gmail.com
研究場所
-
-
-
Asyut、エジプト
- Assiut University Hospitals
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Thoracolumbar interfascial plane Block Group
Patients will receive ultrasound-guided thoracolumbar interfascial plane block after induction of general anesthesia.
|
Ultrasound-guided injection of local anesthetic into the fascial plane between the multifidus and longissimus muscles at the L3 level
|
|
実験的：Retrolaminar Block Group
Patients will receive ultrasound-guided retrolaminar block after induction of general anesthesia.
|
Ultrasound-guided injection of local anesthetic posterior to the vertebral lamina at the L3 level.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Quality of Recovery-15 (QoR-15) score at 24 hours postoperatively
時間枠：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.
|
24 hours postoperatively
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Pain intensity using Visual Analog Scale (VAS)
時間枠：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.
|
30 minutes, 2, 6, 12, and 24 hours postoperatively
|
|
Time to first rescue analgesia
時間枠：Within 24 hours postoperatively
|
Time from the end of surgery to the first request for rescue analgesia (VAS ≥ 4).
|
Within 24 hours postoperatively
|
|
Total nalbuphine consumption
時間枠：24 hours postoperatively
|
Total amount of nalbuphine administered within the first 24 hours after surgery (mg).
|
24 hours postoperatively
|
|
Time to first ambulation
時間枠：From end of surgery to first ambulation, assessed up to 48 hours postoperatively
|
From end of surgery to first ambulation, assessed up to 48 hours postoperatively
|
|
|
Time to tolerate oral intake
時間枠：From end of surgery to first tolerated oral intake, assessed up to 48 hours postoperatively
|
From end of surgery to first tolerated oral intake, assessed up to 48 hours postoperatively
|
|
|
Length of hospital stay
時間枠：From surgery until hospital discharge, assessed up to 7 days postoperatively
|
From surgery until hospital discharge, assessed up to 7 days postoperatively
|
|
|
Incidence of postoperative complications
時間枠：Within 24-48 hours postoperatively
|
Includes nausea, vomiting, pruritus, hypotension, bradycardia, hematoma, infection, and local anesthetic systemic toxicity (LAST).
|
Within 24-48 hours postoperatively
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- TLIP-RLB-QoR-2026
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。