Effect of Intravenous Lidocaine on Immediate Post-operative Pain, Nausea and Vomiting in Patients Undergoing Laparoscopic Cholecystectomy: A Randomized Placebo Controlled Trial

NCT04182828 | Unknown Phase 4

• 1 other identifier: 2019-1558-5378
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Lidocaine is a drug that has multiple uses. One of these is that when intravenously administered it is effective in reducing post-operative pain. The aim of this study is to investigate the beneficial effects of intravenous lignocaine on reducing pain, nausea and vomiting after laparoscopic cholecystectomy. Also, by this research, we are aiming to find a suitable alternative analgesic.

Conditions

Post-operative Pain; Post-operative Nausea and Vomiting

Outcome Measures

Primary Outcomes (2)

• Post-operative pain as assessed on numerical rating scale

  Immediate pain after laparoscopic cholecystectomy

  upto 6 hours

• Post-operative nausea and vomiting as assessed on Bellville nausea score

  feeling of nausea and vomiting after laparoscopic cholecystectomy

  upto 6 hours

Secondary Outcomes (1)

• Discharge time

  upto 24 hours

Study Arms (2)

Placebo Group(PG)

PLACEBO COMPARATOR

It will be normal saline 0.9%

Drug: Lidocaine

Lidocaine Group(LG)

ACTIVE COMPARATOR

It will be lidocaine 2%

Drug: Lidocaine

Interventions

Lidocaine DRUG

both the drugs will be prepared in same volume, color, consistency and appearance

Also known as: Normal saline 0.9%

Lidocaine Group(LG); Placebo Group(PG)

Eligibility Criteria

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

You may qualify if:

• Elective laparoscopic cholecystectomy
• All adults aged between 18 to 65 years
• ASA I and II

You may not qualify if:

• BMI greater than 35kg/m2
• Allergy to local anesthetic agents
• Patient with or history of arrhythmias
• Patients with SGPT greater than 35 IU/L for females and greater than 45 IU/L for males.
• Patients with chronic renal disease and creatinine greater than 1.5mg/dl.
• Chronic use of opioids
• The surgeries which were converted to open procedures.

Sponsors & Collaborators

• Aga Khan University Hospital, Pakistan: lead

Study Sites (1)

Aga Khan University Hospital

Karachi, Sindh, 74800, Pakistan

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative; Vomiting

Interventions

Lidocaine; Saline Solution

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Dr. M. Umer Slote, MBBS

  Aga Khan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. M. Umer Slote, MBBS

CONTACT

0092-3333094346; umerslote_786@hotmail.com

Dr. Faisal Shamim, FCPS

CONTACT

0092-21-34864253; faisal.shamim@aku.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 26, 2019
• First Posted: December 2, 2019
• Study Start: November 25, 2019
• Primary Completion: November 24, 2020
• Study Completion: November 24, 2020
• Last Updated: December 3, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)