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Intravenous Lidocaine and Postoperative Pain Management

Primary Purpose

Postoperative Pain Management

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Lidocaine
Saline Placebo
Sponsored by
Beijing Tongren Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain Management focused on measuring intravenous lidocaine, postoperative pain management

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Department of Anesthesiology; Beijing Tongren HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

intravenous lidocaine

saline placebo

Arm Description

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

same amount volume saline infusion

Outcomes

Primary Outcome Measures

postoperative pain score
visual analogue score (1-10)
postoperative pain score
visual analogue score (1-10)
postoperative pain score
visual analogue score (1-10)
total postoperative opioid consumption
postoperative fentanyl consumption

Secondary Outcome Measures

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.

Full Information

First Posted
December 6, 2016
Last Updated
December 16, 2016
Sponsor
Beijing Tongren Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02997215
Brief Title
Intravenous Lidocaine and Postoperative Pain Management
Official Title
Effect of Intravenous Lidocaine on Postoperative Pain Management After Laparoscopy Cholecystectomy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
May 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Tongren Hospital

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain Management
Keywords
intravenous lidocaine, postoperative pain management

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
intravenous lidocaine
Arm Type
Experimental
Arm Description
intravenous lidocaine 1.5mg/kg during induction then infused at 2mg/kg/h until the end of procedure.
Arm Title
saline placebo
Arm Type
Placebo Comparator
Arm Description
same amount volume saline infusion
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Intervention Description
lidocaine infusion during surgery
Intervention Type
Drug
Intervention Name(s)
Saline Placebo
Intervention Description
saline infusion at same rate as intervention group during surgery
Primary Outcome Measure Information:
Title
postoperative pain score
Description
visual analogue score (1-10)
Time Frame
6 hours after surgery
Title
postoperative pain score
Description
visual analogue score (1-10)
Time Frame
24 hours after surgery
Title
postoperative pain score
Description
visual analogue score (1-10)
Time Frame
72 hours after surgery
Title
total postoperative opioid consumption
Description
postoperative fentanyl consumption
Time Frame
48 hours after surgery
Secondary Outcome Measure Information:
Title
incidence of postoperative complication
Description
opioid-related side effects, such as nausea and vomiting, and the incidence of adverse effects associated with systemic administration of lidocaine.
Time Frame
48 hours after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Department of Anesthesiology; Beijing Tongren Hospital
City
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
CHUXIONG PAN
Phone
8613811760025

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual participants data for primary and secondary outcome measures will be available within 6 months of study completion

Learn more about this trial

Intravenous Lidocaine and Postoperative Pain Management

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