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The Effect of Perioperative Lidocaine Intravenous Infusion on Postoperative Recovery After Spine Surgery.

Primary Purpose

Spinal Diseases

Status

Unknown status

Phase

Phase 4

Locations

Israel

Study Type

Interventional

Intervention

Lidocaine

About this trial

This is an interventional treatment trial for Spinal Diseases

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

spine surgery with general anesthesia

Exclusion Criteria:

lidocaine allergy
hepatic disease
dementia or cognitive decline

Sites / Locations

Sheba Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Lidocaine

Placebo

Arm Description

Patients will receive Lidocaine drip during spine surgery

Patients will receive placebo during spine surgery

Outcomes

Primary Outcome Measures

Postoperative pain

Quality of recovery after surgery will be assessed using Q0R15 questionnaire and analgesic requirement will be monitored using PCA

Secondary Outcome Measures

Full Information

NCT ID

NCT02762656

First Posted

May 3, 2016

Last Updated

May 3, 2016

Sponsor

Sheba Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT02762656

Brief Title

The Effect of Perioperative Lidocaine Intravenous Infusion on Postoperative Recovery After Spine Surgery.

Official Title

The Effect of Perioperative Lidocaine Intravenous Infusion on Postoperative Recovery After Spine Surgery.

Study Type

Interventional

2. Study Status

Record Verification Date

May 2016

Overall Recruitment Status

Unknown status

Study Start Date

June 2016 (undefined)

Primary Completion Date

June 2017 (Anticipated)

Study Completion Date

August 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sheba Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to evaluate the effectiveness of perioperative Lidocaine intravenous infusion in reducing postoperative pain for spine surgery patients.

Detailed Description

Study design: this study used a prospective, randomized, double-blinded, and placebo-controlled clinical trial. Sixty patients scheduled for a spine surgery will be randomly assigned to two groups. Lidocaine group will receive an intravenous bolus injection of lidocaine 1.5 mg/kg before intubation, followed by 2 mg/kg/h continuous infusion during the operation. Placebo group will receive the same dosage of saline at the same time. Analgesic requirement will be monitored using patient-controlled Analgesia (PCA protocol: demand dose is 2 mg of morphine, lockout 5 min, maximum dose 15 mg per hour). Forty-eight hours after surgery, we will check the morphine consumption in two groups. Quality of recovery after surgery will be assessed using Q0R15 questionnaire.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spinal Diseases

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Lidocaine

Arm Type

Active Comparator

Arm Description

Patients will receive Lidocaine drip during spine surgery

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Patients will receive placebo during spine surgery

Intervention Type

Drug

Intervention Name(s)

Lidocaine

Intervention Description

Lidocaine drip during surgery

Primary Outcome Measure Information:

Title

Postoperative pain

Description

Quality of recovery after surgery will be assessed using Q0R15 questionnaire and analgesic requirement will be monitored using PCA

Time Frame

24 hours postop

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: spine surgery with general anesthesia Exclusion Criteria: lidocaine allergy hepatic disease dementia or cognitive decline

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Haim Berkenstadt, MD

Phone

03-5302754

Ext

+972

Haim.Berkenstadt@sheba.health.gov.il

First Name & Middle Initial & Last Name or Official Title & Degree

Vladimir Solovyev, MD

Phone

054-6800749

Ext

+972

gaster1313@gmail.com

Facility Information:

Facility Name

Sheba Medical Center

City

Ramat Gan

ZIP/Postal Code

5262100

Country

Israel

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Links:

URL

http://www.ncbi.nlm.nih.gov/pubmed/24216403

Description

Intraoperative systemic infusion of lidocaine reduces postoperative pain after lumbar surgery: a double-blinded, randomized, placebo-controlled clinical trial.

URL

http://www.ncbi.nlm.nih.gov/pubmed/25785316

Description

Intravenous lidocaine for effective pain relief after a laparoscopic colectomy: a prospective, randomized, double-blind, placebo-controlled study.

URL

http://www.cochrane.org/CD009642/ANAESTH_intravenous-infusion-lidocaine-starting-time-surgery-reduction-pain-and-improvement-recovery-after

Description

Continuous intravenous perioperative lidocaine infusion for postoperative pain and recovery.

Learn more about this trial

The Effect of Perioperative Lidocaine Intravenous Infusion on Postoperative Recovery After Spine Surgery.

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