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Longterm Postoperative Analgesia, Intravenous Lidocaine Infusion

NCT ID: NCT03030560

Last Updated: 2017-11-27

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2016-12-31

Brief Summary

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Spinal fusion is a painful surgery, and control of postoperative pain is difficult. Several studies have indicated that appropriate pain treatment protocols reduce postoperative morbidity, improve the results of the surgery, and decrease hospital costs

Detailed Description

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Forty four patients were randomly allocated into two groups of equal size to receive either lidocaine infusion (Lidocaine group) or 0.9% sodium chloride infusion (Control group).

Randomization: was performed using Lidocaine group and Control group registers, which was placed in sealed envelopes prior to study initiation and opened prior to anesthesia by a physician who prepared the intravenous solution and identified it with the patient number, according to the envelope drawn. The solution was handed to another physician, blind to the prepared solutions' content, who was responsible for the anesthesia. The solution volume was equal. The responsible investigator was remained blind to the chosen group until the end of the study.

Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Investigators
Double Blind

Study Groups

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Lidocaine group

Patients will receive lidocaine infusion.

Group Type ACTIVE_COMPARATOR

Lidocaine

Intervention Type DRUG

patients (n = 20) will receive a loading dose of lidocaine 2 mg ̸ kg slowly IV just before induction of anesthesia, then the lidocaine infusion started at a rate of 3 mg ̸ kg/h, and continued until the end of the operation.

Control group

Patients will receive 0.9% Sodium-chloride infusion infusion

Group Type PLACEBO_COMPARATOR

0.9% Sodium-chloride

Intervention Type DRUG

patients (n = 20) will receive an equal volume of 0.9% saline (both the loading and the infusion), the infusion will be initiated at the time of induction of anesthesia and continued until the end of the operation.

Interventions

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Lidocaine

patients (n = 20) will receive a loading dose of lidocaine 2 mg ̸ kg slowly IV just before induction of anesthesia, then the lidocaine infusion started at a rate of 3 mg ̸ kg/h, and continued until the end of the operation.

Intervention Type DRUG

0.9% Sodium-chloride

patients (n = 20) will receive an equal volume of 0.9% saline (both the loading and the infusion), the infusion will be initiated at the time of induction of anesthesia and continued until the end of the operation.

Intervention Type DRUG

Other Intervention Names

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Xylocaine Normal saline

Eligibility Criteria

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Inclusion Criteria

Age \> 18 years American Society of Anesthesiologists 1-3 status Patients undergoing spinal fusion or fixation

Exclusion Criteria

1. Previous spinal fusion surgery.
2. Morbid obesity (BMI \> 40)
3. Diagnosis of spinal metastatic cancer
4. Allergy to an amide local anesthetic or morphine sulfate
5. History of renal dysfunction, liver dysfunction or congestive heart failure
6. History of substance abuse disorder.
7. Chronic opioid use.
Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abdelrady S Ibrahim, MD

OTHER

Sponsor Role lead

Responsible Party

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Abdelrady S Ibrahim, MD

Assistant professor of anesthesia and ICU

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Mohamed G Abdelraheem, MD

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Locations

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Assiut university faculty of medicine

Asyut, , Egypt

Site Status

Countries

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Egypt

References

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de Oliveira CM, Issy AM, Sakata RK. Intraoperative intravenous lidocaine. Rev Bras Anestesiol. 2010 May-Jun;60(3):325-33. doi: 10.1016/S0034-7094(10)70041-6.

Reference Type BACKGROUND
PMID: 20682165 (View on PubMed)

Other Identifiers

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IRB0000871239

Identifier Type: -

Identifier Source: org_study_id