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Intravenous Lidocaine and Postoperative Pain Management

NCT ID: NCT02997215

Last Updated: 2016-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2017-05-31

Brief Summary

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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

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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.

Conditions

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Postoperative Pain Management

Keywords

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intravenous lidocaine postoperative pain management

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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intravenous lidocaine

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

Group Type EXPERIMENTAL

Lidocaine

Intervention Type DRUG

lidocaine infusion during surgery

saline placebo

same amount volume saline infusion

Group Type PLACEBO_COMPARATOR

Saline Placebo

Intervention Type DRUG

saline infusion at same rate as intervention group during surgery

Interventions

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Lidocaine

lidocaine infusion during surgery

Intervention Type DRUG

Saline Placebo

saline infusion at same rate as intervention group during surgery

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Tongren Hospital

OTHER

Sponsor Role lead

Responsible Party

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YANXIA SUN

Vice-Chief Anesthesiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Anesthesiology; Beijing Tongren Hospital

Beijing, , China

Site Status RECRUITING

Countries

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China

Facility Contacts

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CHUXIONG PAN

Role: primary

Other Identifiers

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2015-YJJ-GGL-008

Identifier Type: -

Identifier Source: org_study_id