Intravenous Lidocaine and Postoperative Pain Management

Sponsor

Beijing Tongren Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02997215

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain Management	Drug: Lidocaine Drug: Saline Placebo	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Effect of Intravenous Lidocaine on Postoperative Pain Management After Laparoscopy Cholecystectomy

Study Start Date :

Jan 1, 2016

Anticipated Primary Completion Date :

Dec 1, 2016

Anticipated Study Completion Date :

May 1, 2017

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

postoperative pain score [6 hours after surgery]
visual analogue score (1-10)
postoperative pain score [24 hours after surgery]
visual analogue score (1-10)
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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Anesthesiology; Beijing Tongren Hospital	Beijing		China	100730

Sponsors and Collaborators

Beijing Tongren Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

YANXIA SUN, Vice-Chief Anesthesiologist, Beijing Tongren Hospital

ClinicalTrials.gov Identifier:

NCT02997215

Other Study ID Numbers:

2015-YJJ-GGL-008

First Posted:

Dec 19, 2016

Last Update Posted:

Dec 19, 2016

Last Verified:

Dec 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Keywords provided by YANXIA SUN, Vice-Chief Anesthesiologist, Beijing Tongren Hospital

intravenous lidocaine

postoperative pain management

Additional relevant MeSH terms:

Pain, Postoperative

Lidocaine

Study Results

No Results Posted as of Dec 19, 2016