Intravenous Lidocaine and Postoperative Pain Management

Effect of Intravenous Lidocaine on Postoperative Pain Management After Laparoscopy Cholecystectomy

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.

Study Overview

• Status: Unknown
• Conditions: Postoperative Pain Management
• Intervention / Treatment: Drug: Lidocaine; Drug: Saline Placebo

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100730
    • Recruiting
    • Department of Anesthesiology; Beijing Tongren Hospital
    • Contact: CHUXIONG PAN; Phone Number: 8613811760025

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intravenous lidocaine; intravenous lidocaine 1.5mg/kg during induction then infused at 2mg/kg/h until the end of procedure.	Drug: Lidocaine; lidocaine infusion during surgery
Placebo Comparator: saline placebo; same amount volume saline infusion	Drug: Saline Placebo; saline infusion at same rate as intervention group during surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Beijing Tongren Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): May 1, 2017

Study Registration Dates

• First Submitted: December 6, 2016
• First Submitted That Met QC Criteria: December 16, 2016
• First Posted (Estimate): December 19, 2016

Study Record Updates

• Last Update Posted (Estimate): December 19, 2016
• Last Update Submitted That Met QC Criteria: December 16, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: intravenous lidocaine; postoperative pain management
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: 2015-YJJ-GGL-008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participants data for primary and secondary outcome measures will be available within 6 months of study completion