Perioperative Systemic Lidocaine for Enhanced Bowel Recovery After Laparoscopic Bariatric Surgery: A Dose Dependent Study
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Postoperative recovery of bowel function
研究概览
简要总结
Increasing rates of obesity over the last few decades have led to growing demand for bariatric surgery, which may resulted in decreased comorbidities and improved patient outcomes. Laparoscopic bariatric surgery has several clinical benefits in terms of improved quality of analgesia, reduced pulmonary complications, enhanced recovery of bowel function, less immune suppression, and shortened duration of hospital stay than open laparotomies.
Some investigators reported delayed return of bowel function for approximately two days after laparoscopic bariatric surgery, despite it occurred one day earlier than after open laparotomy. This potentially can lengthen the duration of hospital stay after bariatric procedures. With the impeding cost of health care in the developing countries, safely reducing length of stay is essential.
Other investigators reported early return of bowel movements during the first postoperative day in 65% of patients undergoing laparoscopic gastric bypass surgery due to reduced morphine use with implementation of a multimodal analgesia strategy including ketorolac, and propoxyphene hydrochloride/acetaminophen.
Lidocaine was investigated in several studies for its use in multi-modal management strategies to reduce postoperative pain and opioid use and enhance recovery. A recent Cochrane review including 45 trials demonstrated that systemic administration of lidocaine was associated with reduced pain scores at most of 'early time points' in patients undergoing laparoscopic abdominal surgery (MD -1.14, 95% CI -1.51 to -0.78; low-quality evidence), shorter times to first flatus (MD -5.49 hours, 95% CI -7.97 to -3.00; low-quality evidence) and first bowel movement (MD -6.12 hours, 95% CI -7.36 to -4.89; low-quality evidence), and less risk of paralytic ileus (risk ratio (RR) 0.38, 95% CI 0.15 to 0.99; low-quality evidence). However, no evidence of effect was found for lidocaine on shortening the time to first defecation. This low-quality evidence may be related to the heterogeneity between the studies in respect to the optimal dose, timing and duration of the administration of intravenous lidocaine.
详细描述
Hypothesis
Recognizing the need for enhanced bowel recovery for patients undergoing laparoscopic bariatric surgery, the investigators hypothesize that perioperative administration of low rather than high intravenous infusion rates of lidocaine can achieve early postoperative restoration of bowel motility at lower plasma levels.
Up to the best of the investigators' knowledge there is no study addressed the effects of perioperative administration of systemic lidocaine on postoperative recovery of bowel function in morbidly obese patients undergoing laparoscopic bariatric procedures.
Aim of the study
This trial aims to compare the effects of perioperative administration of escalating doses of intravenous lidocaine (1.0, 1.5 and 2.0 mg/kg/h) on the perioperative changes in hemodynamic, pain scores, and plasma lidocaine concentrations, postoperative recovery of bowel function, cumulative morphine use, hospital length of stay, and lidocaine related adverse effects in obese patients undergoing laparoscopic bariatric surgeries under general anesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Obese patients with a body mass index equal or greater than 35 kg/m
- •American Society of Anesthesiologists (ASA) II-III
- •Patients scheduled for laparoscopic bariatric surgery under general anesthesia
排除标准
- •History of significant cardiac disease.
- •History of significant respiratory disease.
- •History of significant hepatic disease.
- •History of significant renal diseases.
- •History of an atrio-ventricular block grade II to III.
- •Long QT syndrome.
- •Pre-existing disorder of the gastrointestinal tract.
- •Patients with history of alcohol or drug abuse.
- •Allergy to amide local anesthetics.
- •History of epilepsy.
- •Pregnancy.
- •Patients receiving cardiovascular medications.
- •Patients receiving steroids.
- •Patients receiving an opioid analgesic medication within 24 h before the operation.
- •Conversion from a laparoscopic to an open laparotomy.
研究组 & 干预措施
Placebo
Patients will receive an intravenous bolus of 0.1 mL/kg of saline 0.9% solution followed by a continuous infusion 0.1 mL/kg/h of Saline 0.9% which will be continued for 24 hours after surgery.
干预措施: Placebo (Drug)
Lidocaine 1%
Patients will receive an intravenous bolus of 0.1 mL/kg of lidocaine 1.5% solution followed by a continuous infusion 0.1 mL/kg/h of lidocaine 1% solution which will be continued for 24 hours after surgery.
All medications in the study protocol will be based on the dosing body weight [ideal body weight (IBW) + 0.4 × (actual body weight-IBW)]
干预措施: Lidocaine 1% (Drug)
Lidocaine 1.5%
Patients will receive an intravenous bolus of 0.1 mL/kg of lidocaine 1.5% solution followed by a continuous infusion 0.1 mL/kg/h of lidocaine 1,5% solution which will be continued for 24 hours after surgery.
干预措施: Lidocaine 1.5% (Drug)
Lidocaine 2%
Patients will receive an intravenous bolus of 0.1 mL/kg of lidocaine 1.5% solution followed by a continuous infusion 0.1 mL/kg/h of lidocaine 2% solution which will be continued for 24 hours after surgery.
干预措施: Lidocaine 2% (Drug)
结局指标
主要结局
Postoperative recovery of bowel function
时间窗: For 72 hours after surgery
Times to first passage of flatus, first defecation, and tolerating liquids measured in hours from the end of surgery. Patients will be asked to note the time they will be able to tolerate liquids and their first passage of flatus ("gas").
次要结局
- Perioperative changes in blood pressure(For 48 hours after surgery)
- Pain scores(For 48 hours after surgery)
- Perioperative use of intravenous fluids(For 48 hours after surgery)
- Perioperative use of dobutamine(For 48 hours after surgery)
- Perioperative changes in cognitive function(For 48 hours after surgery)
- Postoperative nausea and vomiting(For 48 hours after surgery)
- Serum lidocaine level(For 48 hours after surgery)
- Plasma albumin level(For 48 hours after surgery)
- Perioperative changes in heart rate(For 48 hours after surgery)
- Perioperative use of norepinephrine(For 48 hours after surgery)
- Time to readiness for hospital(for 10 days after surgery)
- Postoperative pruritus(For 48 hours after surgery)
- Postoperative sedation(For 48 hours after surgery)
- The balance between the fluid intake and output(For 48 hours after surgery)
- Times to clinical recovery(For 2 hours after surgery)
- Length of Post-Anaesthesia Care Unit stay(For 4 hours after surgery)
- Number of participants with surgery-related complications(For 15 days after surgery)
- Intraoperative total use of fentanyl(For 4 hours after induction of anaesthesia)
- Postoperative cumulative morphine use(For 48 hours after surgery)
- Time to actual discharge from hospital(For 10 days after surgery)
- Overall patient satisfaction score(For 48 hours after surgery)
- Number of participants with lidocaine treatment-related adverse events(For 48 hours after surgery)
- Associated comorbidities(For 1 day before induction of anaesthesia)