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

NCT ID: NCT02762656

Last Updated: 2016-05-05

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2017-08-31

Brief Summary

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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

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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.

Conditions

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Spinal Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Lidocaine

Patients will receive Lidocaine drip during spine surgery

Group Type ACTIVE_COMPARATOR

Lidocaine

Intervention Type DRUG

Lidocaine drip during surgery

Placebo

Patients will receive placebo during spine surgery

Group Type PLACEBO_COMPARATOR

Lidocaine

Intervention Type DRUG

Lidocaine drip during surgery

Interventions

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Lidocaine

Lidocaine drip during surgery

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* spine surgery with general anesthesia

Exclusion Criteria

* lidocaine allergy
* hepatic disease
* dementia or cognitive decline
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Sheba Medical Center

Ramat Gan, , Israel

Site Status

Countries

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Israel

Central Contacts

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Haim Berkenstadt, MD

Role: CONTACT

03-5302754 ext. +972

Vladimir Solovyev, MD

Role: CONTACT

054-6800749 ext. +972

Related Links

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

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

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

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

Other Identifiers

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SHEBA-16-2972-VS-CTIL

Identifier Type: -

Identifier Source: org_study_id

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