Intravenous Lidocaine and Postoperative Pain Management

Phase 4

• Conditions: Postoperative Pain Management
• Interventions: Drug: Lidocaine; Drug: Saline Placebo

• Registration Number: NCT02997215
• Lead Sponsor: Beijing Tongren Hospital

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.

Study Timeline

• Study Start: 2016-01
• Status Verified: 2016-12
• Primary Completion: 2016-12
• Study First Submitted: 2016-12-06
• Study First Submitted QC: 2016-12-16
• Last Update Submitted: 2016-12-16
• Study First Posted: 2016-12-19
• Last Update Posted: 2016-12-19
• Study Completion: 2017-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intravenous lidocaine	Lidocaine	intravenous lidocaine 1.5mg/kg during induction then infused at 2mg/kg/h until the end of procedure.
saline placebo	Saline Placebo	same amount volume saline infusion

Primary Outcome Measures

Name	Time	Method
postoperative pain score	72 hours after surgery	visual analogue score (1-10)
total postoperative opioid consumption	48 hours after surgery	postoperative fentanyl consumption

Secondary Outcome Measures

Name	Time	Method
incidence of postoperative complication	48 hours after surgery	opioid-related side effects, such as nausea and vomiting, and the incidence of adverse effects associated with systemic administration of lidocaine.

Trial Locations

Locations (1)

Department of Anesthesiology; Beijing Tongren Hospital; 🇨🇳 Beijing, China