Perioperative Systemic Lidocaine for Enhanced Bowel Recovery After Bariatric Surgery

NCT02607488 | Suspended Phase 1 DMC

• 1 other identifier: R-15-10-47
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Obese patients; Undergoing bariatric surgery

Outcome Measures

Primary Outcomes (1)

• Postoperative recovery of bowel function

  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").

  For 72 hours after surgery

Secondary Outcomes (23)

• Perioperative changes in heart rate

  For 48 hours after surgery

• Perioperative changes in blood pressure

  For 48 hours after surgery

• Pain scores

  For 48 hours after surgery

• Intraoperative total use of fentanyl

  For 4 hours after induction of anaesthesia

• Perioperative use of intravenous fluids

  For 48 hours after surgery

Study Arms (4)

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Lidocaine 1%

ACTIVE COMPARATOR

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

Drug: Lidocaine 1%

Lidocaine 1.5%

ACTIVE COMPARATOR

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.

Drug: Lidocaine 1.5%

Lidocaine 2%

ACTIVE COMPARATOR

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.

Drug: Lidocaine 2%

Interventions

Placebo DRUG

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

Placebo

Lidocaine 1% DRUG

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

Lidocaine 1%

Lidocaine 1.5% DRUG

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

Lidocaine 1.5%

Lidocaine 2% DRUG

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

Lidocaine 2%

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Obese patients with a body mass index equal or greater than 35 kg/m2.
• American Society of Anesthesiologists (ASA) II-III
• Patients scheduled for laparoscopic bariatric surgery under general anesthesia

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University Hospitals

Al Mansurah, DK, 050, Egypt

Location

MeSH Terms

Conditions

Obesity

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• 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

  STUDY CHAIR

• Samah El Kenany, MD

  Department of Anaesthesia and Surgical Intensive Care, College of Medicine, Mansoura University, Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2015
• First Posted: November 18, 2015
• Study Start: November 1, 2020
• Primary Completion: December 1, 2022
• Study Completion: February 1, 2023
• Last Updated: September 4, 2020

Record last verified: 2020-09

Locations

EG (1)