Comparing Analgesic Efficacy of Systemic Lidocaine Against Placebo in General Anesthesia in Bariatric Surgery

NCT03667001 | Completed Phase 3

• 1 other identifier: CTU 17/026
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators plan to evaluate the analgesic effect of systemic Lidocaine in addition to general anesthesia during bariatric surgery. Patients will be subdivided into a "Lidocaine group" and a "Control group". The primary outcome will be the proportion of patients suffering from higher pain intensity within the first four hours after bariatric surgery. Secondary outcomes include the average maximal pain intensity during first four hours and during 48 hours, total opiate consumption, occurence of postoperative nausea and vomiting, time to first defecation and total time spent in hospital.

Conditions

Pain, Postoperative

Keywords

systemic lidocain

Outcome Measures

Primary Outcomes (1)

• Postoperative VAS/NRS Score

  Any development of VAS/NRS score \> 3 (Visual Analog Scale/Numeric Rating Scale ranging from minimum 0 to maximum 10 points, with 0 points as "no pain" to 10 points as "severe pain") , in hourly measurements within the first four hours after completion of bariatric surgery to evaluate the pain experienced by patients after the surgical intervention

  0 - 4 hours after surgery

Secondary Outcomes (5)

• Average experienced maximal pain during the first four hours and 48 hours after Surgery

  0 - 48 hours after surgery

• Occurence of Postoperative Nausea and Vomiting after Surgery

  0 - 48 hours after surgery

• Time to first Defecation

  0 - 48 hours after surgery

• Duration of Hospitalization

  0 - 48 hours after surgery

• Total Amount of Opiate Consumption

  0 - 48 hours after surgery

Study Arms (2)

Lidocaine Hydrochloride

EXPERIMENTAL

* 1.5 mg/kg lean body mass lidocaine (lidocaine 1%) bolus I.V. as general anesthesia steady state concentration is accomplished * 1.5 mg/kg lean body mass/h lidocaine I.V. with beginning of surgical procedures * after completion of surgery: transfer to PACU, pain evaluation for 48 hours * duration of intervention: lidocaine infusion up to four hours from completion of surgery, or till transfer to surgical ward

Drug: Lidocaine Hydrochloride

Saline Solution

PLACEBO COMPARATOR

* 0.15 ml/kg lean body mass saline 0.9% bolus I.V. as general anesthesia steady state concentration is accomplished * 0.15 ml/kg lean body mass/h saline 0.9% I.V. with beginning of surgical procedure * after completion of surgery: transfer to PACU, pain evaluation for 48 hours * duration of intervention: saline infusion up to four hours from completion of surgery, or till transfer to surgical ward

Drug: Saline Solution

Interventions

Lidocaine Hydrochloride DRUG

The intervention to be studied will be the additional application of systemic lidocaine 1% dosed 1.5 ml/kg LBM to general anesthesia in bariatric surgery. Patients, randomly assigned to one study group, will be surveyed for 48 hours after completion of surgery, experienced pain, occurrence of PONV, time to first defecation and length of hospitalization will be monitored. Patients, medical practitioner, nurses and investigators will be blinded by utilization of equal appearance and packing of IMPs, which will be fabricated individually for each patient and on request one to two days before surgery by the pharmacy. Each patient will self-evaluate his maximal experienced pain eight-hourly during a sequence of 48 hours after completion of surgery.

Also known as: Lidocaine Group

Lidocaine Hydrochloride

Saline Solution DRUG

The intervention to be studied will be the additional application of NaCl 0.9% dosed 1.5 ml/kg LBM to general anesthesia in bariatric surgery as a placebo. Patients, randomly assigned to one study group, will be surveyed for 48 hours after completion of surgery, experienced pain, occurrence of PONV, time to first defecation and length of hospitalization will be monitored. Each patient will self-evaluate his maximal experienced pain eight-hourly during a sequence of 48 hours after completion of surgery.

Also known as: Placebo Group

Saline Solution

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• elective laparoscopic bariatric surgery
• ASA classification I - III
• age 18 - 80
• given informed consent

You may not qualify if:

• no written consent
• allergy to the investigational product
• cardiac arrhythmia (pacemaker)
• liver dysfunction (Child-Pugh classification A, B or C)
• pregnancy
• central nervous disease
• chronic pain and pre-existing opiate prescription
• expected non-compliance
• drug/alcohol abuse

Sponsors & Collaborators

• Miodrag Filipovic, Prof. Dr. med.: lead

Study Sites (1)

Cantonal Hospital of St. Gallen

Sankt Gallen, 9007, Switzerland

Location

Related Publications (9)

• McCarthy GC, Megalla SA, Habib AS. Impact of intravenous lidocaine infusion on postoperative analgesia and recovery from surgery: a systematic review of randomized controlled trials. Drugs. 2010 Jun 18;70(9):1149-63. doi: 10.2165/10898560-000000000-00000.

  PMID: 20518581 BACKGROUND

• Vigneault L, Turgeon AF, Cote D, Lauzier F, Zarychanski R, Moore L, McIntyre LA, Nicole PC, Fergusson DA. Perioperative intravenous lidocaine infusion for postoperative pain control: a meta-analysis of randomized controlled trials. Can J Anaesth. 2011 Jan;58(1):22-37. doi: 10.1007/s12630-010-9407-0.

  PMID: 21061107 BACKGROUND

• Cui W, Li Y, Li S, Wang R, Li J. Systemic administration of lidocaine reduces morphine requirements and postoperative pain of patients undergoing thoracic surgery after propofol-remifentanil-based anaesthesia. Eur J Anaesthesiol. 2010 Jan;27(1):41-6. doi: 10.1097/EJA.0b013e32832d5426.

  PMID: 19478674 BACKGROUND

• Herroeder S, Pecher S, Schonherr ME, Kaulitz G, Hahnenkamp K, Friess H, Bottiger BW, Bauer H, Dijkgraaf MG, Durieux ME, Hollmann MW. Systemic lidocaine shortens length of hospital stay after colorectal surgery: a double-blinded, randomized, placebo-controlled trial. Ann Surg. 2007 Aug;246(2):192-200. doi: 10.1097/SLA.0b013e31805dac11.

  PMID: 17667496 BACKGROUND

• Groudine SB, Fisher HA, Kaufman RP Jr, Patel MK, Wilkins LJ, Mehta SA, Lumb PD. Intravenous lidocaine speeds the return of bowel function, decreases postoperative pain, and shortens hospital stay in patients undergoing radical retropubic prostatectomy. Anesth Analg. 1998 Feb;86(2):235-9. doi: 10.1097/00000539-199802000-00003.

  PMID: 9459225 BACKGROUND

• Weibel S, Jokinen J, Pace NL, Schnabel A, Hollmann MW, Hahnenkamp K, Eberhart LH, Poepping DM, Afshari A, Kranke P. Efficacy and safety of intravenous lidocaine for postoperative analgesia and recovery after surgery: a systematic review with trial sequential analysis. Br J Anaesth. 2016 Jun;116(6):770-83. doi: 10.1093/bja/aew101.

  PMID: 27199310 BACKGROUND

• De Oliveira GS Jr, Duncan K, Fitzgerald P, Nader A, Gould RW, McCarthy RJ. Systemic lidocaine to improve quality of recovery after laparoscopic bariatric surgery: a randomized double-blinded placebo-controlled trial. Obes Surg. 2014 Feb;24(2):212-8. doi: 10.1007/s11695-013-1077-x.

  PMID: 24036842 BACKGROUND

• Janmahasatian S, Duffull SB, Ash S, Ward LC, Byrne NM, Green B. Quantification of lean bodyweight. Clin Pharmacokinet. 2005;44(10):1051-65. doi: 10.2165/00003088-200544100-00004.

  PMID: 16176118 BACKGROUND

• Yurttas T, Djurdjevic M, Schnider TW, Filipovic M. Analgesic efficacy of systemic lidocaine using lean body mass based dosing regime versus placebo in bariatric surgery: a prospective, randomised, double-blind, placebo-controlled, single-centre study. Br J Anaesth. 2023 Jul;131(1):122-129. doi: 10.1016/j.bja.2023.03.027. Epub 2023 May 12.

  PMID: 37183098 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Lidocaine; Saline Solution

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Miodrag Filipovic, Prof.Dr.med.

  Deputy Head of the Clinic for Anesthesiology & Intensive Care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Measures taken to minimize or avoid bias include randomization and blinding of participants after they have given their informed consent. Blinding of medical practitioner and medical personnel will be conducted by provision of equal looking and packing of IMPs, which will be fabricated individually for each patient and on request one to two days before surgery by the pharmacy.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy Head of the Clinic for Anesthesiology and Intensive Care

Model Details: The investigators plan to evaluate the analgesic effect of systemic Lidocaine in Addition to general anesthesia during bariatric surgery. * Lidocaine group: perioperative application of systemic Lidocaine up to four hours from end of surgical procedures. * Control group: perioperative application of Placebo (NaCl 0.9%) up to four hours from end of surgical procedures.

Study Record Dates

• First Submitted: August 24, 2018
• First Posted: September 12, 2018
• Study Start: November 16, 2018
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2021
• Last Updated: July 28, 2021

Record last verified: 2021-07

Locations

CH (1)