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Clinical Trials/NCT02997215
NCT02997215
Unknown
Phase 4

Effect of Intravenous Lidocaine on Postoperative Pain Management After Laparoscopy Cholecystectomy

Beijing Tongren Hospital1 site in 1 country80 target enrollmentJanuary 2016

Overview

Phase
Phase 4
Intervention
Lidocaine
Conditions
Postoperative Pain Management
Sponsor
Beijing Tongren Hospital
Enrollment
80
Locations
1
Primary Endpoint
postoperative pain score
Last Updated
9 years ago

Overview

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.

Detailed Description

Postoperative pain and ileus are primary reasons for delayed patient recovery and longer hospital stays after abdominal surgery. Opioids have been widely used to treat pain in this patient population. However, opioid administration can exacerbate postoperative ileus and further delay patient recovery. Multimodal approaches and adjunctive therapies are therefore recommended for pain control after abdominal surgery to reduce opioid consumption and opioid-related adverse effects. Studies have reported that systemically administered lidocaine has analgesic, anti-inflammatory, and anti-hyperalgesic effects. Several clinical trials have been published that evaluated systemically administered lidocaine for postoperative pain management and recovery after surgery. However, the evidence for beneficial effects of systemic lidocaine for postoperative recovery remains controversial. Therefore, the investigators performed this study to evaluate the efficacy of systemic administration of lidocaine for postoperative analgesia and gastrointestinal recovery after laparoscopic cholecystectomy. The investigators primary hypothesis is that systemic lidocaine administration reduces pain intensity following surgery.

Registry
clinicaltrials.gov
Start Date
January 2016
End Date
May 2017
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Beijing Tongren Hospital
Responsible Party
Principal Investigator
Principal Investigator

YANXIA SUN

Vice-Chief Anesthesiologist

Beijing Tongren Hospital

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Arms & Interventions

intravenous lidocaine

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

Intervention: Lidocaine

saline placebo

same amount volume saline infusion

Intervention: Saline Placebo

Outcomes

Primary Outcomes

postoperative pain score

Time Frame: 72 hours after surgery

visual analogue score (1-10)

total postoperative opioid consumption

Time Frame: 48 hours after surgery

postoperative fentanyl consumption

Secondary Outcomes

  • incidence of postoperative complication(48 hours after surgery)

Study Sites (1)

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