Intraoperative Lidocaine Infusion vs. Esmolol Infusion for Postoperative Analgesia in Laparoscopic Cholecystectomy

NCT02327923 | Completed Phase 4 DMC

• 1 other identifier: IERB/284/014
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Comparison of intraoperative infusion of lidocaine and esmolol in the postoperative requirement of opioid for postoperative pain management after laparoscopic cholecystectomy to decrease opioid related side effects and enhance postoperative recovery with multimodal analgesia approach.

Conditions

Gall Stone Disease

Keywords

Laparoscopic cholecystectomy; lidocaine infusion; Esmolol infusion; Postoperative opioid consumption; Multimodal analgesia

Outcome Measures

Primary Outcomes (1)

• Opioid (morphine equivalent) requirement in the first 24 h postoperatively

  total morphine consumed in the first 24 h postoperatively

  up to 24 hours postoperatively

Secondary Outcomes (6)

• Visual analogue scale (VAS) scores for pain severity

  up to 24 hours postoperatively

• Incidence of postoperative nausea and vomiting (PONV).

  up to 24 hours postoperatively

• Time to first voiding

  up to first 24 hours postoperatively

• Sedation score using Ramsay Scale.

  up to 24 hours postoperatively

• Patient satisfaction following Laparoscopic cholecystectomy

  at 24 hours postoperatively

Study Arms (2)

Lidocaine

ACTIVE COMPARATOR

Intravenous bolus administration of lidocaine at the time of induction followed by infusion till the last suture.

Drug: Lidocaine; Drug: Paracetamol; Drug: Propofol; Drug: Fentanyl; Drug: Vecuronium; Drug: Atropine; Drug: Ephedrine; Drug: Morphine; Drug: Ketorolac; Drug: Ondansetron; Drug: Bupivacaine; Drug: Tramadol; Drug: Neostigmine; Drug: Glycopyrrolate

Esmolol

ACTIVE COMPARATOR

Intravenous bolus administration of esmolol at the time of induction followed by infusion till the last suture.

Drug: Esmolol; Drug: Paracetamol; Drug: Lidocaine; Drug: Propofol; Drug: Fentanyl; Drug: Vecuronium; Drug: Atropine; Drug: Ephedrine; Drug: Morphine; Drug: Ketorolac; Drug: Ondansetron; Drug: Bupivacaine; Drug: Tramadol; Drug: Neostigmine; Drug: Glycopyrrolate

Interventions

Lidocaine DRUG

Lidocaine intravenous 1.5mg/kg IV bolus at the time of induction followed by IV infusion @ 1.5 mg/kg/hr till the last suture.

Also known as: Lignocaine, Xylocaine

Lidocaine

Esmolol DRUG

Esmolol intravenous bolus 0.5 mg/kg at the time of induction followed by infusion @ 5-15 microgram/kg/min till the last suture.

Esmolol

Paracetamol DRUG

Inj. Paracetamol 1 gm IV at the time of induction

Esmolol; Lidocaine

Propofol DRUG

Inj. Propofol 2- 2.5 mg/kg will be given for induction

Esmolol; Lidocaine

Fentanyl DRUG

Inj fentanyl 1.5mg/kg will be given at the time of induction.

Esmolol; Lidocaine

Vecuronium DRUG

Inj Vecuronium 0.1mg/kg will be given at induction and for maintenance.

Esmolol; Lidocaine

Atropine DRUG

Inj Atropine 0.4 mg IV will be given for bradycardia (HR \< 50/min)

Esmolol; Lidocaine

Ephedrine DRUG

Esmolol; Lidocaine

Morphine DRUG

Esmolol; Lidocaine

Ketorolac DRUG

Esmolol; Lidocaine

Ondansetron DRUG

Esmolol; Lidocaine

Bupivacaine DRUG

Inj. Bupivacaine 0.25% 10 ml will be infiltrated at incision site after closure.

Esmolol; Lidocaine

Tramadol DRUG

Inj tramadol 50 mg IV will be given on SOS basis in ward.

Esmolol; Lidocaine

Neostigmine DRUG

50 mcg/kg for reversal of residual neuromuscular blockade

Esmolol; Lidocaine

Glycopyrrolate DRUG

10 mcg/kg with neostigmine

Esmolol; Lidocaine

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adult female patients of ASA physical status I or II, between age of 18 to 60 years undergoing elective laparoscopic cholecystectomy under general anaesthesia.

You may not qualify if:

• Refusal to give consent.
• ASA physical status III or more.
• Inability to comprehend pain assessment score or severe mental impairment.
• Difficult intubation.
• Pregnancy.
• Morbid obesity.
• History of epilepsy.
• History of allergy to any drug used in the study.
• History of ongoing use of opioids or beta adrenergic receptor antagonists.
• Baseline heart rate less than 50 beats per minute.
• Presence of pain immediately before surgery.
• Chronic pain other than gall stone disease.
• Gastrointestinal ulceration, bleeding disorder.
• Peritonitis (including previous), perforated gall bladder, severe acute cholecystitis, known to have choledocholithiasis.

Sponsors & Collaborators

• B.P. Koirala Institute of Health Sciences: lead

Study Sites (1)

BP Koirala Institute of Health Sciences

Dharān, Sunsari District, Nepal

Location

Related Publications (8)

• Collard V, Mistraletti G, Taqi A, Asenjo JF, Feldman LS, Fried GM, Carli F. Intraoperative esmolol infusion in the absence of opioids spares postoperative fentanyl in patients undergoing ambulatory laparoscopic cholecystectomy. Anesth Analg. 2007 Nov;105(5):1255-62, table of contents. doi: 10.1213/01.ane.0000282822.07437.02.

  PMID: 17959952 BACKGROUND

• Lauwick S, Kim DJ, Michelagnoli G, Mistraletti G, Feldman L, Fried G, Carli F. Intraoperative infusion of lidocaine reduces postoperative fentanyl requirements in patients undergoing laparoscopic cholecystectomy. Can J Anaesth. 2008 Nov;55(11):754-60. doi: 10.1007/BF03016348.

  PMID: 19138915 BACKGROUND

• 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

• Marret E, Rolin M, Beaussier M, Bonnet F. Meta-analysis of intravenous lidocaine and postoperative recovery after abdominal surgery. Br J Surg. 2008 Nov;95(11):1331-8. doi: 10.1002/bjs.6375.

  PMID: 18844267 BACKGROUND

• Lee MH, Chung MH, Han CS, Lee JH, Choi YR, Choi EM, Lim HK, Cha YD. Comparison of effects of intraoperative esmolol and ketamine infusion on acute postoperative pain after remifentanil-based anesthesia in patients undergoing laparoscopic cholecystectomy. Korean J Anesthesiol. 2014 Mar;66(3):222-9. doi: 10.4097/kjae.2014.66.3.222. Epub 2014 Mar 28.

  PMID: 24729845 BACKGROUND

• Lopez-Alvarez S, Mayo-Moldes M, Zaballos M, Iglesias BG, Blanco-Davila R. Esmolol versus ketamine-remifentanil combination for early postoperative analgesia after laparoscopic cholecystectomy: a randomized controlled trial. Can J Anaesth. 2012 May;59(5):442-8. doi: 10.1007/s12630-012-9684-x. Epub 2012 Mar 2.

  PMID: 22383085 BACKGROUND

• Ozturk T, Kaya H, Aran G, Aksun M, Savaci S. Postoperative beneficial effects of esmolol in treated hypertensive patients undergoing laparoscopic cholecystectomy. Br J Anaesth. 2008 Feb;100(2):211-4. doi: 10.1093/bja/aem333. Epub 2007 Nov 23.

  PMID: 18037672 BACKGROUND

• Bajracharya JL, Subedi A, Pokharel K, Bhattarai B. The effect of intraoperative lidocaine versus esmolol infusion on postoperative analgesia in laparoscopic cholecystectomy: a randomized clinical trial. BMC Anesthesiol. 2019 Nov 4;19(1):198. doi: 10.1186/s12871-019-0874-8.

  PMID: 31684867 DERIVED

MeSH Terms

Interventions

Lidocaine; esmolol; Acetaminophen; Propofol; Fentanyl; Vecuronium Bromide; Atropine; Ephedrine; Morphine; Ketorolac; Ondansetron; Bupivacaine; Tramadol; Neostigmine; Glycopyrrolate

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Propanolamines; Amino Alcohols; Alcohols; Propanols; Phenethylamines; Ethylamines; Morphine Derivatives; Morphinans; Opiate Alkaloids; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Imidazoles; Azoles; Carbazoles; Heterocyclic Compounds, 3-Ring; Cyclohexanols; Hexanols; Fatty Alcohols; Dimethylamines; Methylamines; Lipids; Phenylammonium Compounds; Quaternary Ammonium Compounds; Onium Compounds; Pyrrolidines

Study Officials

• Asish Subedi, MD

  B.P. Koirala Institute of Health Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Junior resident

Study Record Dates

• First Submitted: October 12, 2014
• First Posted: December 31, 2014
• Study Start: January 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: April 1, 2016
• Last Updated: November 30, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

NE (1)