Comparison of Paragastric Nerve Block and Erector Spinae Plane Block on Postoperative Pain After Sleeve Gastrectomy (PGB-ESP)
A Prospective Randomized Controlled Trial Comparing the Effects of Paragastric Nerve Block and Erector Spinae Plane Block on Postoperative Pain Management Following Laparoscopic Sleeve Gastrectomy
Background: Laparoscopic sleeve gastrectomy is one of the most commonly performed bariatric procedures for the treatment of obesity. Despite its minimally invasive nature, patients frequently experience moderate to severe postoperative pain, which may delay mobilization, prolong hospital stay, increase opioid consumption, and reduce patient satisfaction. Effective postoperative pain management is therefore an important component of perioperative care.
Regional analgesia techniques are increasingly used as part of multimodal analgesia protocols to reduce opioid requirements and opioid-related adverse effects. Paragastric nerve block (PGNB) has been reported to provide effective control of visceral pain, nausea, and vomiting after sleeve gastrectomy. Erector spinae plane block (ESPB) is another regional anesthesia technique that has demonstrated efficacy in reducing perioperative opioid consumption in bariatric surgery patients. However, no prospective randomized study has directly compared PGNB and ESPB in patients undergoing sleeve gastrectomy.
This prospective, randomized, controlled clinical trial aims to compare the effects of PGNB, ESPB, and standard analgesia on postoperative pain management following laparoscopic sleeve gastrectomy. Seventy-two adult patients scheduled for elective sleeve gastrectomy will be randomized in a 1:1:1 ratio to receive PGNB, ESPB, or standard multimodal analgesia alone. The primary outcome will be postoperative pain intensity measured using the Visual Analog Scale (VAS) at 1, 6, 12, and 24 hours after surgery. Secondary outcomes include postoperative opioid consumption, intraoperative remifentanil consumption, additional analgesic requirements, time to first analgesic request, postoperative nausea and vomiting, and block-related complications.
調査の概要
状態
詳細な説明
Laparoscopic sleeve gastrectomy is one of the most frequently performed bariatric surgical procedures for the treatment of morbid obesity. Although the procedure is minimally invasive, patients commonly experience moderate to severe postoperative pain during the early postoperative period. Inadequate pain control may delay mobilization, prolong hospital stay, increase pulmonary complications, reduce patient satisfaction, and increase opioid consumption, leading to opioid-related adverse effects such as nausea, vomiting, sedation, and respiratory depression.
Regional anesthesia techniques have become an important component of multimodal analgesia protocols aimed at improving postoperative pain control while reducing opioid requirements. Paragastric nerve block (PGNB) is a surgeon-performed regional analgesic technique targeting visceral afferent nerve fibers surrounding the stomach. Previous studies have suggested that PGNB may reduce postoperative pain, opioid consumption, nausea, and vomiting following sleeve gastrectomy. Erector spinae plane block (ESPB) is an ultrasound-guided fascial plane block that has gained popularity in thoracoabdominal surgery because of its ease of application, favorable safety profile, and potential analgesic benefits. ESPB has been shown to reduce perioperative opioid consumption and improve postoperative analgesia in bariatric surgical patients.
Despite the growing use of both techniques, there is limited evidence directly comparing PGNB and ESPB in patients undergoing laparoscopic sleeve gastrectomy. Therefore, the optimal regional analgesic technique for this patient population remains uncertain.
The present study is designed as a prospective, randomized, controlled, parallel-group clinical trial conducted at Atlas University Faculty of Medicine Hospital. Following Institutional Review Board approval and written informed consent, 72 adult patients scheduled for elective laparoscopic sleeve gastrectomy will be enrolled. Eligible participants will be between 18 and 65 years of age, classified as ASA physical status II-III, and meet established bariatric surgery criteria.
Participants will be randomly assigned in a 1:1:1 ratio to one of three study groups:
- Paragastric Nerve Block (PGNB) Group: Patients will receive intraoperative paragastric nerve block performed by the operating surgeon using 18 mL of 0.5% bupivacaine distributed across predefined paragastric anatomical regions.
- Erector Spinae Plane Block (ESPB) Group: Patients will receive bilateral ultrasound-guided ESPB at the T6 vertebral level before surgery using 0.25% bupivacaine, with a maximum dose not exceeding 2 mg/kg.
- Control Group: Patients will receive standard perioperative multimodal analgesia without regional block intervention.
All participants will undergo standardized general anesthesia and multimodal analgesia protocols. Intraoperative remifentanil administration will be titrated according to routine clinical practice.
The primary outcome measure will be postoperative pain intensity assessed using the Visual Analog Scale (VAS) at 1, 6, 12, and 24 hours after surgery.
Secondary outcome measures will include:
- Total postoperative analgesic and opioid consumption during the first 24 hours.
- Additional analgesic requirements.
- Time to first analgesic request.
- Intraoperative remifentanil consumption.
- Incidence of postoperative nausea and vomiting.
- Block-related adverse events and complications, including local anesthetic systemic toxicity, hematoma, or infection.
Postoperative assessments will be performed by investigators blinded to group allocation whenever feasible. Data will be collected during the intraoperative period, post-anesthesia care unit stay, and throughout the first 24 postoperative hours.
The findings of this study are expected to provide evidence regarding the comparative effectiveness and safety of PGNB and ESPB for postoperative pain management following laparoscopic sleeve gastrectomy and may contribute to the optimization of perioperative analgesic strategies in bariatric surgery.
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:Ergun Gunduz, M.D., Assistant Professor
- 電話番号:+905327448021
- メール:ergun.gunduz@atlas.edu.tr
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: - Age between 18 and 65 years Scheduled for elective Sleeve Gastrectomy surgery Classified as ASA physical status II-III Body mass index (BMI) ≥30 kg/m² with obesity-related comorbidities or BMI ≥40 kg/m² Willing to participate in the study and has provided written informed consent
Exclusion Criteria:
- Known allergy or hypersensitivity to local anesthetic agents Allergy or contraindication to paracetamol or NSAIDs Coagulopathy or current anticoagulant therapy Infection or skin lesions at the site of block application Chronic pain syndrome Chronic opioid use, opioid dependence, or use of gabapentin/pregabalin Previous upper gastrointestinal surgery Moderate to severe renal impairment (eGFR <60 mL/min/1.73 m²) Moderate to severe liver disease (Child-Pugh B-C or active hepatic disease) Planned additional surgical procedures Inability to assess pain using VAS Refusal to participate in the study
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:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的:Paragastric Nerve Block (PGNB)
Participants will receive an intraoperative paragastric nerve block performed by the surgeon using 18 mL of 0.5% bupivacaine administered to predefined paragastric anatomical regions in addition to standard general anesthesia and multimodal analgesia.
|
Ultrasound-guided paragastric nerve block performed intraoperatively for postoperative analgesia.
Bilateral ultrasound-guided erector spinae plane block performed at the T6 vertebral level before surgery using 0.25% bupivacaine.
The total dose will not exceed 2 mg/kg.
The block is administered in addition to standard general anesthesia and multimodal analgesia.
Patients receive standard perioperative multimodal analgesia without regional anesthesia techniques.
Intravenous paracetamol (1 g) and dexketoprofen (50 mg) are administered intraoperatively according to institutional protocol.
|
|
実験的:Erector Spinae Plane Block (ESPB)
Participants will receive bilateral ultrasound-guided erector spinae plane block at the T6 vertebral level before surgery in addition to standard general anesthesia and multimodal analgesia.
|
Ultrasound-guided paragastric nerve block performed intraoperatively for postoperative analgesia.
Bilateral ultrasound-guided erector spinae plane block performed at the T6 vertebral level before surgery using 0.25% bupivacaine.
The total dose will not exceed 2 mg/kg.
The block is administered in addition to standard general anesthesia and multimodal analgesia.
Patients receive standard perioperative multimodal analgesia without regional anesthesia techniques.
Intravenous paracetamol (1 g) and dexketoprofen (50 mg) are administered intraoperatively according to institutional protocol.
|
|
アクティブコンパレータ:No Intervention
Participants will receive standard perioperative multimodal analgesia without regional anesthesia.
Intravenous paracetamol and dexketoprofen will be administered according to the institutional analgesia protocol.
|
Ultrasound-guided paragastric nerve block performed intraoperatively for postoperative analgesia.
Bilateral ultrasound-guided erector spinae plane block performed at the T6 vertebral level before surgery using 0.25% bupivacaine.
The total dose will not exceed 2 mg/kg.
The block is administered in addition to standard general anesthesia and multimodal analgesia.
Patients receive standard perioperative multimodal analgesia without regional anesthesia techniques.
Intravenous paracetamol (1 g) and dexketoprofen (50 mg) are administered intraoperatively according to institutional protocol.
|
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 |
|---|---|---|
|
Primary Outcome
時間枠:Postoperative Hours 1, 6, 12, and 24
|
The primary outcome of this study is the assessment of postoperative pain levels.
Pain intensity will be measured using the Visual Analog Scale (VAS; 0 = no pain, 10 = worst imaginable pain) at the 1st, 6th, 12th, and 24th postoperative hours.
The effectiveness of the analgesic techniques will be evaluated by comparing VAS scores between the groups.
|
Postoperative Hours 1, 6, 12, and 24
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協力者と研究者
スポンサー
出版物と役立つリンク
一般刊行物
- Ul Huda A, Alshahrani AS, Yasir M, Sawilah A, Alharthi AAN. Erector spinae block reduces intraoperative and postoperative opioid consumption in patients undergoing laparoscopic sleeve gastrectomy: A randomized controlled trial. Qatar Med J. 2024 Dec 26;2024(4):58. doi: 10.5339/qmj.2024.58. eCollection 2024.
- Katar MK, Turan UF. Efficacy and Safety of Paragastric Neural Blockade in Controlling Pain, Nausea, and Vomiting After Sleeve Gastrectomy: A Randomized Controlled Trial. Obes Surg. 2024 Jul;34(7):2383-2390. doi: 10.1007/s11695-024-07255-9. Epub 2024 May 7.
便利なリンク
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
その他の研究ID番号
- ATLAS -PGB-ESP-2026-1
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?
IPD プランの説明
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
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