Intravenous Lidocaine and Postoperative Pain Management

NCT02997215 | Unknown Phase 4 DMC

• 1 other identifier: 2015-YJJ-GGL-008
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This study was to evaluate the effect of intraoperative intravenous lidocaine on postoperative pain management after laparoscopic cholecystectomy. Half of patients will receive intravenous lidocaine during procedure, the rest half of patients will receive regular anesthesia care and placebo treatment.

Conditions

Postoperative Pain Management

Keywords

intravenous lidocaine; postoperative pain management

Outcome Measures

Primary Outcomes (4)

• postoperative pain score

  visual analogue score (1-10)

  6 hours after surgery

• postoperative pain score

  visual analogue score (1-10)

  24 hours after surgery

• postoperative pain score

  visual analogue score (1-10)

  72 hours after surgery

• total postoperative opioid consumption

  postoperative fentanyl consumption

  48 hours after surgery

Secondary Outcomes (1)

• incidence of postoperative complication

  48 hours after surgery

Study Arms (2)

intravenous lidocaine

EXPERIMENTAL

intravenous lidocaine 1.5mg/kg during induction then infused at 2mg/kg/h until the end of procedure.

Drug: Lidocaine

saline placebo

PLACEBO COMPARATOR

same amount volume saline infusion

Drug: Saline Placebo

Interventions

Lidocaine DRUG

lidocaine infusion during surgery

intravenous lidocaine

Saline Placebo DRUG

saline infusion at same rate as intervention group during surgery

saline placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologist (ASA) status I-II adult patients undergoing elective laparoscopic cholecystectomy.

You may not qualify if:

• Open surgery;
• Patients allergic to lidocaine or other local anesthetics;
• Drug abuser.

Sponsors & Collaborators

• Beijing Tongren Hospital: lead

Study Sites (1)

Department of Anesthesiology; Beijing Tongren Hospital

Beijing, 100730, China

RECRUITING

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice-Chief Anesthesiologist

Study Record Dates

• First Submitted: December 6, 2016
• First Posted: December 19, 2016
• Study Start: January 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: May 1, 2017
• Last Updated: December 19, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)