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Trial record 44 of 107 for:    ( Map: Nepal )

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

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ClinicalTrials.gov Identifier: NCT02327923
Recruitment Status : Completed
First Posted : December 31, 2014
Last Update Posted : November 8, 2016
Sponsor:
Information provided by (Responsible Party):
Joshan Lal Bajracharya, B.P. Koirala Institute of Health Sciences

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.

Condition or disease Intervention/treatment Phase
Gall Stone Disease Drug: Lidocaine Drug: Esmolol 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 Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intraoperative Lidocaine Infusion vs. Esmolol Infusion for Postoperative Analgesia in Laparoscopic Cholecystectomy: a Randomized Clinical Trial
Study Start Date : October 2014
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Lidocaine
Intravenous bolus administration of lidocaine at the time of induction followed by infusion till the last suture.
Drug: Lidocaine
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.
Other Name: Lignocaine, Xylocaine

Drug: Paracetamol
Inj. Paracetamol 1 gm IV at the time of induction

Drug: Lidocaine
Inj. Xylocaine 2% 3 ml will be infiltrated in skin in all port sites prior to incision.
Other Name: Xylocaine

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

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

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

Drug: Atropine
Inj Atropine 0.4 mg IV will be given for bradcardia (HR < 50/min)

Drug: Ephedrine
Drug: Morphine
Drug: Ketorolac
Drug: Ondansetron
Drug: Bupivacaine
Inj. Bupivacaine 0.25% 10 ml will be infiltrated at incision site after closure.

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

Drug: Neostigmine
50 mcg/kg for reversal of residual neuromuscular blockade

Drug: Glycopyrrolate
10 mcg/kg with neostigmine

Active Comparator: Esmolol
Intravenous bolus administration of esmolol at the time of induction followed by infusion till the last suture.
Drug: Esmolol
Esmolol intravenous bolus 0.5 mg/kg at the time of induction followed by infusion @ 5-15 microgram/kg/min till the last suture.

Drug: Paracetamol
Inj. Paracetamol 1 gm IV at the time of induction

Drug: Lidocaine
Inj. Xylocaine 2% 3 ml will be infiltrated in skin in all port sites prior to incision.
Other Name: Xylocaine

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

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

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

Drug: Atropine
Inj Atropine 0.4 mg IV will be given for bradcardia (HR < 50/min)

Drug: Ephedrine
Drug: Morphine
Drug: Ketorolac
Drug: Ondansetron
Drug: Bupivacaine
Inj. Bupivacaine 0.25% 10 ml will be infiltrated at incision site after closure.

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

Drug: Neostigmine
50 mcg/kg for reversal of residual neuromuscular blockade

Drug: Glycopyrrolate
10 mcg/kg with neostigmine




Primary Outcome Measures :
  1. Opioid (morphine equivalent) requirement in the first 24 h postoperatively [ Time Frame: 24 hours ]
    • Pain at rest and with cough or movement using the VAS scale during first 24 h postoperatively.
    • Time to first analgesic request (time counted after skin closure).
    • Opioid (morphine equivalent) requirement in the first 24 h postoperatively.


Secondary Outcome Measures :
  1. Occurrence of toxicity or clinically significant adverse events in all patients for first 24 h. [ Time Frame: 24 hours ]
    • Occurrence of toxicity or clinically significant adverse events in all patients for first 24 h.
    • Incidence of postoperative nausea and vomiting (PONV) in the first 24 h using PONV scoring.
    • Time to first voiding.
    • Sedation score using Modified Ramsay Scale during first 24 h postoperatively.
    • Patient satisfaction following LC using Likert Satisfaction Scale at 24 h following surgery.

  2. Incidence of postoperative nausea and vomiting (PONV). [ Time Frame: 24 h ]
    Incidence of postoperative nausea and vomiting (PONV) in the first 24 h using PONV scoring.

  3. Time to first voiding [ Time Frame: h ]
  4. Sedation score using Modified Ramsay Scale. [ Time Frame: 24 h ]
    Sedation score using Modified Ramsay Scale during first 24 h postoperatively.

  5. Patient satisfaction following Laparoscopic cholecystectomy [ Time Frame: 24 h ]
    Patient satisfaction following LC using Likert Satisfaction Scale at 24 h following surgery



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.
  • Placement of intra-abdominal drain; sub-hepatic or sub-diaphragmatic drain.
  • 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, previous upper abdominal surgery.
  • Conversion to laparotomy from laparoscopy.

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): NCT02327923


Locations
Nepal
BP Koirala Institute of Health Sciences
Dharan, Sunsari district, Nepal
Sponsors and Collaborators
B.P. Koirala Institute of Health Sciences
Investigators
Study Director: Asish Subedi, MD BP Koirala Institute of Health Sciences

Publications:

Responsible Party: Joshan Lal Bajracharya, Junior resident, B.P. Koirala Institute of Health Sciences
ClinicalTrials.gov Identifier: NCT02327923     History of Changes
Other Study ID Numbers: IERB/284/014
First Posted: December 31, 2014    Key Record Dates
Last Update Posted: November 8, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Joshan Lal Bajracharya, B.P. Koirala Institute of Health Sciences:
Laparoscopic cholecystectomy
lidocaine infusion
Esmolol infusion
Postoperative opioid consumption
Multimodal analgesia

Additional relevant MeSH terms:
Gallstones
Cholelithiasis
Cholecystolithiasis
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical
Bupivacaine
Lidocaine
Propofol
Fentanyl
Morphine
Ondansetron
Tramadol
Acetaminophen
Ketorolac
Atropine
Neostigmine
Ephedrine
Vecuronium Bromide
Glycopyrrolate
Esmolol
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents