Perioperative Systemic Lidocaine for Enhanced Bowel Recovery After Bariatric Surgery

Summary

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.

Conditions

• Obesity
• Bariatric Surgery Candidate

Interventions

DRUG

Placebo

Participants 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. All medications in the study protocol will be based on the dosing body weight \[ideal body weight (IBW) + 0.4 × (actual body weight-IBW)\]

DRUG

Lidocaine 1%

Participants 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 \[ideal body weight (IBW) + 0.4 × (actual body weight-IBW)\]

DRUG

Lidocaine 1.5%

Participants 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. All medications in the study protocol will be based on the dosing body weight \[ideal body weight (IBW) + 0.4 × (actual body weight-IBW)\]

DRUG

Lidocaine 2%

Participants 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. All medications in the study protocol will be based on the dosing body weight \[ideal body weight (IBW) + 0.4 × (actual body weight-IBW)\]

Sponsors & Collaborators

• Mansoura University

  lead OTHER

Principal Investigators

• Mohamed R El Tahan, MD · Departments of Anaesthesia and Surgical Intensive Care, College of Medicine, Mansoura University, Egypt, and Anesthesiology Department, College of Medicine, University of Dammam, Saudi Arabia

• Samah El Kenany, MD · Department of Anaesthesia and Surgical Intensive Care, College of Medicine, Mansoura University, Egypt

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-11-30

Primary Completion

2022-12-31

Completion

2023-02-28

Countries

• Egypt

Study Locations