Impact of Intraoperative Paragastric Block on Visceral Pain and Postoperative Nausea and Vomiting After Sleeve Gastrectomy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Visceral pain score measured by Visual Analog Scale (VAS)
研究概览
简要总结
This single-center, prospective, randomized, double-blind controlled trial aims to evaluate the effects of intraoperative paragastric block (PGBLOCK) on early postoperative visceral pain, postoperative nausea and vomiting (PONV), and analgesic requirements in patients undergoing laparoscopic sleeve gastrectomy (LSG). Despite advancements in multimodal analgesia protocols, visceral pain remains a significant postoperative concern following LSG, contributing to increased opioid use and delayed recovery. Paragastric block is a novel technique targeting autonomic neural pathways-such as branches of the celiac ganglia and vagal nerves-through precise intraoperative injection of local anesthetics near the stomach.
A total of 180 patients scheduled for elective LSG will be randomized in a 1:1 ratio to receive either paragastric block with 20 mL of 0.5% bupivacaine or a sham block with 20 mL of isotonic saline. Injections will be administered at six predefined anatomical sites under laparoscopic guidance after gastric resection. The surgical technique, anesthetic protocol, and postoperative care will be standardized for all participants. Both patients and clinical personnel involved in care and outcome assessment will remain blinded to group assignment.
The primary outcome is the assessment of postoperative visceral pain using Visual Analog Scale (VAS) scores at 0 and 2 hours postoperatively. Secondary outcomes include PONV severity grading, mobilization status, total analgesic consumption (pethidine + tramadol), and need for rescue antiemetics within the first 24 hours post-surgery. Exclusion criteria include history of upper abdominal surgery, chronic opioid use, pregnancy, severe systemic disease, or allergy to medications used in the protocol.
This study is expected to provide high-quality evidence regarding the efficacy of paragastric block in improving early postoperative recovery and reducing opioid reliance after LSG.
详细描述
Introduction Laparoscopic sleeve gastrectomy (LSG) is one of the most frequently preferred methods for surgical treatment of obesity. However, postoperative visceral pain and its associated autonomic manifestations, particularly postoperative nausea and vomiting (PONV), significantly impair patient recovery, delay mobilization, and extend hospitalization duration. Contemporary multimodal analgesia protocols effectively address somatic components of pain but demonstrate limited efficacy in managing visceral pain pathways, which predominate following LSG. This results in increased opioid use and related complications. Paragastric block (PGBLOCK) represents an emerging technique specifically designed to target the autonomic neural pathways responsible for visceral pain transmission. This technique involves precise infiltration of local anesthetics to autonomic nerve plexuses surrounding the stomach, including branches of the celiac ganglia and vagal pathways.
This study was designed to evaluate the effects of intraoperative paragastric block application on early postoperative visceral pain, PONV, and analgesic requirements in patients undergoing LSG.
Materials and Methods Study Design This study will be designed as a single-center, prospective, randomized, controlled, double-blinded clinical trial. This study will comply with both the ethical standards of the institutional and/or national research committee and the principles outlined in the 1964 Helsinki Declaration and its later amendments. The study protocol will be reviewed and approved by the Ethics Committee of Marmara University School of Medicine. Following the approval of the ethics committee, the study will be registered at ClinicalTrials.gov.
A total of 180 patients will be randomized into two groups: the intervention group undergoing LSG with intraoperative paragastric block using 20 mL of 0.5% bupivacaine (n=90), and the placebo group undergoing LSG with sham paragastric block using 20 mL of isotonic saline (n=90). In both groups, the injection will be performed at six predefined anatomical sites under direct laparoscopic visualization, following completion of gastric resection. To preserve blinding, the procedural technique-including injection sites, needle type, and volume-will be identical in both groups. Neither the surgical team nor the patients will be aware of the group allocation. The study will include a CONSORT flow diagram illustrating participant progression through all trial phases.
Inclusion Criteria
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The surgical team, anesthesia providers, patients, data collectors, and outcome assessors will all remain blinded to group allocation. To preserve masking, both the intervention and placebo procedures will be performed identically in terms of injection site, volume, and technique. Group assignment will be concealed using sequentially numbered, opaque envelopes opened only after induction of anesthesia.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Paragastric Block with Bupivacaine
Participants in this group will undergo laparoscopic sleeve gastrectomy with intraoperative paragastric block. A total of 20 mL of 0.5% bupivacaine will be injected into six predefined anatomical sites around the stomach under direct laparoscopic visualization after gastric resection. The block targets autonomic nerve plexuses to reduce postoperative visceral pain and nausea. The injection will be performed using a standardized technique with a 25G needle.
干预措施: Bupivacaine 0.5% (Drug)
Sham Block with Isotonic Saline
Participants in this group will undergo laparoscopic sleeve gastrectomy with a sham paragastric block. A total of 20 mL of isotonic saline will be injected into the same six anatomical sites using the same technique, timing, needle type, and volume as the intervention group, ensuring proper blinding. No active local anesthetic will be used.
干预措施: Isotonic Saline (0.9% NaCl) (Drug)
结局指标
主要结局
Visceral pain score measured by Visual Analog Scale (VAS)
时间窗: At 0 and 2 hours postoperatively
Postoperative visceral pain will be assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). Scores will be recorded by blinded observers at specific postoperative time points.
次要结局
- Postoperative nausea and vomiting (PONV) grade(At 0, 2, 6, and 12 hours postoperatively)
- Early mobilization status(At 2 hours postoperatively)
- Cumulative analgesic consumption (pethidine + tramadol)(Within 24 hours postoperatively)
- Rescue antiemetic requirement(Within 24 hours postoperatively)
研究者
Abdullah Sisik
Professor of General Surgery
Istanbul Gedik University