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Perioperative Systemic Lidocaine for Enhanced Bowel Recovery After Bariatric Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02607488
Recruitment Status : Suspended (No fund no enough recruiting centers)
First Posted : November 18, 2015
Last Update Posted : September 4, 2020
Sponsor:
Information provided by (Responsible Party):
Mansoura University

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.


Condition or disease Intervention/treatment Phase
Obesity Bariatric Surgery Candidate Drug: Placebo Drug: Lidocaine 1% Drug: Lidocaine 1.5% Drug: Lidocaine 2% Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Perioperative Systemic Lidocaine for Enhanced Bowel Recovery After Laparoscopic Bariatric Surgery: A Dose Dependent Study
Estimated Study Start Date : November 2020
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : February 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: 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.
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)]


Active Comparator: 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)]

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)]


Active Comparator: 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.
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)]


Active Comparator: 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.
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)]





Primary Outcome Measures :
  1. Postoperative recovery of bowel function [ Time Frame: 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").


Secondary Outcome Measures :
  1. Perioperative changes in heart rate [ Time Frame: For 48 hours after surgery ]
    Heart rate will be recorded before induction of anesthesia, 5 min after induction, every 15 min intraoperatively, and then 1 h, 4 h, 12 h, 24 h, 36 h, 48 h after surgery

  2. Perioperative changes in blood pressure [ Time Frame: For 48 hours after surgery ]
    Blood pressure will be recorded before induction of anesthesia, 5 min after induction, every 15 min intraoperatively, and then 1 h, 4 h, 12 h, 24 h, 36 h, 48 h after surgery

  3. Pain scores [ Time Frame: For 48 hours after surgery ]
    Four-hourly pain scores at rest and during movement and cough

  4. Intraoperative total use of fentanyl [ Time Frame: For 4 hours after induction of anaesthesia ]
    Fentanyl0.5 micrograms/kilogram of body weight will be administered intravenously on the discretion of the charged anesthesiologist in case of inadequate intraoperative analgesia

  5. Perioperative use of intravenous fluids [ Time Frame: For 48 hours after surgery ]
    The volume of intravenously administered fluid therapy will be recorded before, during, and after surgery.

  6. Perioperative use of norepinephrine [ Time Frame: For 48 hours after surgery ]
    The volume of intravenously administered norepinephrine to treat low blood pressure will be recorded before, during, and after surgery.

  7. Perioperative use of dobutamine [ Time Frame: For 48 hours after surgery ]
    The volume of intravenously administered dobutamine to treat low cardiac output will be recorded before, during, and after surgery.

  8. The balance between the fluid intake and output [ Time Frame: For 48 hours after surgery ]
    The balance between the fluid intake and output during surgery and 34 hours and 48 hours after surgery will be recorded

  9. Postoperative cumulative morphine use [ Time Frame: For 48 hours after surgery ]
    Intravenous morphine will be administered intravenously as per request of the participants to relief their postoperative pain. The cumulative consumption of morphine by participants will be recorded at 24 hours and 48 hours after surgery

  10. Times to clinical recovery [ Time Frame: For 2 hours after surgery ]
    Times to spontaneous breathing, eye opening, obeying verbal commands, and extubation

  11. Length of Post-Anaesthesia Care Unit stay [ Time Frame: For 4 hours after surgery ]
  12. Time to readiness for hospital [ Time Frame: for 10 days after surgery ]
  13. Time to actual discharge from hospital [ Time Frame: For 10 days after surgery ]
  14. Perioperative changes in cognitive function [ Time Frame: For 48 hours after surgery ]
    It will be assessed using as assessed by a mini mental score preoperatively (baseline) and 24 h and 48 h after surgery

  15. Overall patient satisfaction score [ Time Frame: For 48 hours after surgery ]
    This will be assessed using a 100-point scale with 1 = completely dissatisfied to 100 = completely satisfied) will be recorded on postoperative day (POD)s 1, and 2

  16. Postoperative nausea and vomiting [ Time Frame: For 48 hours after surgery ]
    It will be scored 4-hourly as follows; (0: no nausea; 1: nausea no vomiting; 2: nausea and vomiting)

  17. Postoperative pruritus [ Time Frame: For 48 hours after surgery ]
    This will be assessed at four hourly as follows pruritus rated using a categorical scale (0, none; 1, mild; 2, moderate; and 3, severe)

  18. Postoperative sedation [ Time Frame: For 48 hours after surgery ]
    This will be assessed at 4-hourly using sedation score (four-point verbal rating scores (VRS): awake, drowsy, arousable or deep sleep)

  19. Number of participants with surgery-related complications [ Time Frame: For 15 days after surgery ]
    These include the occurrence of bleeding, fever, wound dehiscence, wound infection, anastomotic leak, abscess, peritonitis, infection

  20. Associated comorbidities [ Time Frame: For 1 day before induction of anaesthesia ]
    These include preoperative diabetes, renal impairment, hepatic dysfunction, cardiac dysfunction, pulmonary disease, endocrine disease

  21. Number of participants with lidocaine treatment-related adverse events [ Time Frame: For 48 hours after surgery ]
    These adverse events include arrhythmia, sedation, nausea and vomiting, light-headedness, headache, perioral numbness, tunnel vision, or seizures

  22. Serum lidocaine level [ Time Frame: For 48 hours after surgery ]
  23. Plasma albumin level [ Time Frame: For 48 hours after surgery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02607488


Locations
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Egypt
Mansoura University Hospitals
Mansoura, DK, Egypt, 050
Sponsors and Collaborators
Mansoura University
Investigators
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Study Chair: 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
Principal Investigator: Samah El Kenany, MD Department of Anaesthesia and Surgical Intensive Care, College of Medicine, Mansoura University, Egypt
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Responsible Party: Mansoura University
ClinicalTrials.gov Identifier: NCT02607488    
Other Study ID Numbers: R-15-10-47
First Posted: November 18, 2015    Key Record Dates
Last Update Posted: September 4, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mansoura University:
Obese patients
Undergoing bariatric surgery
Additional relevant MeSH terms:
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Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action