REduced Pain After Bariatric Surgery - Gastric Bypass (REPABS-BPG)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Pain Score
研究概览
简要总结
This study aims to analyze the effect of laparoscopic guided transversus abdominis plane (LG-TAP) block compared to placebo for postoperative analgesia following laparoscopic gastric bypass. One group of participants received a (LG-TAP) block with local anesthetic while the other group received (LG-TAP) block with saline solution (placebo).
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective Laparoscopic Gastric Bypass
- •Body Mass Index (BMI) > 35 kg/m² and at least one condition related to obesity (e.g., hypertension, type II diabetes, dyslipidemia, hepatic steatosis, etc)
- •BMI > 40 kg/m², even in the absence of comorbidities
- •ASA physical status score < 4
排除标准
- •ASA physical status score ≥ 4
- •Patient's refusal or inability to sign the informed consent
- •Allergies to any drug provided by the study protocol
研究组 & 干预措施
LG-TAP
The laparoscopic guided TAP Block was performed at the beginning of surgery, injecting 15 ml of Local Anesthetic (Ropivacaine Hydrochloride 0.5%) on each side, using an atraumatic needle (10/15 cm length, 20 Gauge diameter) close to the anterior axillary line, between the iliac crest and the subcostal margin. Correct needle tip positioning between the transverse muscle of the abdomen and the internal oblique was verified through laparoscopic guidance.
干预措施: LG-TAP block with local anesthetic (Drug)
LG-TAP
The laparoscopic guided TAP Block was performed at the beginning of surgery, injecting 15 ml of Local Anesthetic (Ropivacaine Hydrochloride 0.5%) on each side, using an atraumatic needle (10/15 cm length, 20 Gauge diameter) close to the anterior axillary line, between the iliac crest and the subcostal margin. Correct needle tip positioning between the transverse muscle of the abdomen and the internal oblique was verified through laparoscopic guidance.
干预措施: Port site infiltration (Procedure)
PLACEBO
The laparoscopic guided TAP Block was performed at the beginning of surgery, injecting 15 ml of Saline solution (NaCl 0.9%) on each side, using an atraumatic needle (10/15 cm length, 20 Gauge diameter) close to the anterior axillary line, between the iliac crest and the subcostal margin. Correct needle tip positioning between the transverse muscle of the abdomen and the internal oblique was verified through laparoscopic guidance.
干预措施: Port site infiltration (Procedure)
PLACEBO
The laparoscopic guided TAP Block was performed at the beginning of surgery, injecting 15 ml of Saline solution (NaCl 0.9%) on each side, using an atraumatic needle (10/15 cm length, 20 Gauge diameter) close to the anterior axillary line, between the iliac crest and the subcostal margin. Correct needle tip positioning between the transverse muscle of the abdomen and the internal oblique was verified through laparoscopic guidance.
干预措施: LG-TAP block with saline solution (Drug)
结局指标
主要结局
Pain Score
时间窗: 24 hours
A numerical rating scale (NRS) from 0 (no pain) to 10 (worst imaginable pain) will be used to evaluate pain at rest during 24 hours after surgery
次要结局
- Morphine Consumption(24 hours)
- Ketorolac Consumption(24 hours)
- Nausea and/or Vomiting(48 hours)
- Length of Hospital Stay(72 hours)
- Timt to walking(72 hours)
- Time to first flatus(72 hours)
- Surgical Complications(7 days)
研究者
Vincenzo Bruni
Principal Investigator
Fondazione Policlinico Universitario Campus Bio-Medico