A Pilot Study to Assess the Feasibility of a Future Randomized, Double-Blinded, Placebo-Controlled Trial to Investigate the Role of Intra-Peritoneal Ropivacaine in Gastric Bypass Surgery: INOPAIN Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- 8-12 Hours Post Operative Pain Level
研究概览
简要总结
This is a pilot study in a randomized, controlled, double-blinded format and will evaluate the ability of a local anesthetic, Ropivacaine, to decrease pain after gastric bypass surgery. The drug will be administered into the abdomen during a bariatric bypass surgery. After surgery, patients who received Ropivacaine will be compared to those without Ropivacaine to determine its effect on reducing pain, recovery of lung function, ability to walk, and quality of life during recovery.
详细描述
Introduction
Postoperative pain control remains a major challenge for surgical procedures, including laparoscopic gastric bypass. Pain management is particularly relevant in obese patients who experience a higher number of of cardiovascular and pulmonary events. effective pain management may reduce their risk of serious postoperative complications, such as deep venous thrombosis and pulmonary emboli. The objective of this study is to evaluate the efficacy of intraperitoneal local anaesthetic, ropivacaine, to reduce postoperative pain in patients undergoing laparoscopic Roux-en-Y gastric bypass.
Methods and Analysis: A randomized controlled trial will be conducted to compare intraperitoneal ropivacaine (Intervention) versus normal saline (placebo) in 120 adult patients undergoing bariatric surgery. Ropivacaine will be infused over the oesophageal hiatus and throughout the abdomen. Patients in the control arm will undergo the same treatment as normal saline. The primary end point will be postoperative pain at 1, 2 and 4 hours postoperatively. Pain measurements will then occur every 4 hours for 24 h and every 8h until discharge. Secondary endpoints will include opioid use, peak expiratory flow, 6 min walk distance and quality of life. Intention-to-treat analysis will be used and repeated measures will be analysed using mixed model approach. post-hoc pairwise comparison of the treatment groups at different time points will be carried out using multiple comparisons with adjustments to the type 1 error. Results of the study will inform the feasibility of effectiveness of intraperitoneal ropivacaine.
Ethics and dissemination This study has been approved by the Ottawa Health Science Network Research Ethics Board and Health Canada in April 2014. The findings of the study will be disseminated through national and international conferences and peer-reviewed journals.
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)
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
- •Patients undergoing Roux-en-Y gastric bypass surgery;
- •Patients who able to tolerate general anesthetic and pneumoperitoneum;
- •Patients who able to provide informed consent for the surgery;
- •Patients over the age of 18 years;
排除标准
- •Patient undergoing planned Sleeve Gastrectomy (inta-op conversion to Sleeve Gastrectomy after delivery of intraperitoneal ropivacaine will be included and analyzed using intention-to-treat approach)
- •Patients with an allergy to local anesthetics
- •Patients with severe underlying cardiovascular disease (ie: congestive heart failure, conduction abnormalities, and ischemic heart disease)
- •Patients with chronic renal disease Stage 3 or greater (Creatinine clearance less than 60mL/hr (millilitre per hour))
- •Patients with hepatic dysfunction Child-Pugh Class B or C
- •Patients with previous foregut surgery including esophageal, gastric, liver, and pancreas resections
研究组 & 干预措施
Intraperitoneal Normal Saline
Intraperitoneal Normal Saline: 100mL (Milliliter) normal saline administered as in intervention arm
干预措施: Normal Saline (Drug)
Intraperitoneal ropivacaine
The abdomen will be entered and trocars placed in the usual manner. Using a standard suction/irrigation device and tubing, 200mg of Ropivacaine (0.2% Ropivacaine in 100mL Normal Saline) will be instilled into the abdomen at the start of the case, prior to dissection as follows. Under direct visualization, 50mL (Milliliter) (of the 100mL) will be infused over the esophageal hiatus. The remaining 50mL will be infused throughout the abdomen. The infusion line will then be flushed with 30mL (Milliliter) of Normal Saline to ensure the entire treatment dose is delivered, and no Ropivacaine remains in the tubing. The remainder of the surgery will proceed as usual.
干预措施: Ropivacaine (Drug)
结局指标
主要结局
8-12 Hours Post Operative Pain Level
时间窗: 8-12 hours post operatively
Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome).
0-1 h Postoperative Pain Level
时间窗: 0-1 hours post operatively
Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome).
1-2 h Postoperative Pain Level
时间窗: 1-2 hours post operatively
Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome).
16-20 Hours Post Operative Pain Level
时间窗: 16-20 hours post operatively
Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome).
20-24 Hours Post Operative Pain Level
时间窗: 20-24 hours post operatively
Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome).
24-32 Hours Post Operative Pain Level
时间窗: 24-32 hours post operatively
Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome).
2-4 Hours Post Operative Pain Level
时间窗: 2-4 hours post operatively
Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome).
4-8 Hours Post Operative Pain Level
时间窗: 4-8 hours post operatively
Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome).
12-16 Hours Post Operative Pain Level
时间窗: 12-16 hours post operatively
Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome).
32-40 Hours Post Operative Pain Level
时间窗: 32-40 hours post operatively
Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome).
40-48 Hours Post Operative Pain Level
时间窗: 40-48 hours post operatively
Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome).
次要结局
- 1h Peak Expiratory Flow (PEF) Score(1 hours post operatively)
- 2h Peak Expiratory Flow (PEF) Score(2 hours post operatively)
- 4h Peak Expiratory Flow (PEF) Score(4 hours post operatively)
- 8h Peak Expiratory Flow (PEF) Score(8 hours post operatively)
- 12h Peak Expiratory Flow (PEF) Score(12 hours post operatively)
- 16h Peak Expiratory Flow (PEF) Score(16 hours post operatively)
- 20h Peak Expiratory Flow (PEF) Score(20 hours post operatively)
- 24h Peak Expiratory Flow (PEF) Score(24 hours post operatively)
- 32h Peak Expiratory Flow (PEF) Score(32 hours post operatively)
- 6 Minute Walking Distance Post Operative Day 1 (POD1)(Post operative day 1)
- 1-2 h Postoperative Ketorolac Consumption(1-2 hours post operatively)
- 40h Peak Expiratory Flow (PEF) Score(40 hours post operatively)
- 48h Peak Expiratory Flow (PEF) Score(48 hours post operatively)
- 6 Minute Walking Distance Post Operative Day 2 (POD2)(Post operative day 2)
- Postoperative Day 1 Quality of Recovery Questionnaire (QR-40)(Post operative day 1)
- 0-1 h Postoperative Tylenol Consumption(0-1 hours post operatively)
- 0-1 h Postoperative Ketorolac Consumption(0-1 hours post operatively)
- 0-1 h Postoperative Dilaudid Consumption(0-1 hours post operatively)
- 0-1 h Postoperative Tramadol Consumption(0-1 h Postoperative Tramadol consumption)
- 0-1 h Postoperative Fentanyl Consumption(0-1 hours post operatively)
- 1-2 h Postoperative Tylenol Consumption(1-2 hours post operatively)
- 1-2 h Postoperative Dilaudid Consumption(1-2 hours post operatively)
- 1-2 h Postoperative Tramadol Consumption(1-2 hours post operatively)
- 1-2 h Postoperative Fentanyl Consumption(1-2 hours post operatively)
- 2-4 h Postoperative Tylenol Consumption(2-4 hours post operatively)
- 2-4 h Postoperative Ketorolac Consumption(2-4 hours post operatively)
- 2-4 h Postoperative Dilaudid Consumption(2-4 hours post operatively)
- 2-4 h Postoperative Tramadol Consumption(2-4 hours post operatively)
- 2-4 h Postoperative Fentanyl Consumption(2-4 hours post operatively)
- 4-12 h Postoperative Tylenol Consumption(4-12 hours post operatively)
- 4-12 h Postoperative Ketorolac Consumption(4-12 hours post operatively)
- 4-12 h Postoperative Tramadol Consumption(4-12 hours post operatively)
- 4-12 h Postoperative Dilaudid Consumption(4-12 hours post operatively)
- 12-24 h Postoperative Tylenol Consumption(12-24 hours post operatively)
- 12-24 h Postoperative Tramadol Consumption(12-24 hours post operatively)
- 12-24 h Postoperative Dilaudid Consumption(12-24 hours post operatively)
- 12-24 h Postoperative Ketorolac Consumption(12-24 hours post operatively)
- 24-48 h Postoperative Tramadol Consumption(24-48 hours post operatively)
- 24-48 h Postoperative Dilaudid Consumption(24-48 hours post operatively)
- Postoperative Day 7-10 Quality of Recovery Questionnaire (QR-40)(Post operative day 7-10)
- 24-48 h Postoperative Tylenol Consumption(24-48 hours post operatively)
- 24-48 h Postoperative Ketorolac Consumption(24-48 hours post operatively)
- 6 Minute Walking Distance Post Operative Day 7-10 (POD 7-10)(Post operative day 7-10 (Follow-up Clinic))