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Clinical Trials/NCT03030560
NCT03030560
Completed
Phase 2

Effect of Intravenous Lidocaine Infusion on Long Term Postoperative Pain After Spinal Fusion Surgery

Abdelrady S Ibrahim, MD1 site in 1 country40 target enrollmentApril 2015

Overview

Phase
Phase 2
Intervention
Lidocaine
Conditions
Postoperative Pain
Sponsor
Abdelrady S Ibrahim, MD
Enrollment
40
Locations
1
Primary Endpoint
numerical rating scale (NRS), pain score.
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
April 2015
End Date
December 2016
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Abdelrady S Ibrahim, MD
Responsible Party
Sponsor Investigator
Principal Investigator

Abdelrady S Ibrahim, MD

Assistant professor of anesthesia and ICU

Assiut University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Previous spinal fusion surgery.
  • Morbid obesity (BMI \> 40)
  • Diagnosis of spinal metastatic cancer
  • Allergy to an amide local anesthetic or morphine sulfate
  • History of renal dysfunction, liver dysfunction or congestive heart failure
  • History of substance abuse disorder.
  • Chronic opioid use.

Arms & Interventions

Lidocaine group

Patients will receive lidocaine infusion.

Intervention: Lidocaine

Control group

Patients will receive 0.9% Sodium-chloride infusion infusion

Intervention: 0.9% Sodium-chloride

Outcomes

Primary Outcomes

numerical rating scale (NRS), pain score.

Time Frame: Postoperative 3 months

Postoperative numerical rating scale (NRS), pain score.

Secondary Outcomes

  • opioid consumption.(Postoperative 24 h)
  • Serum cortisol.(Postoperative 24 h)

Study Sites (1)

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