Longterm Postoperative Analgesia, Intravenous Lidocaine Infusion

Phase 2

Completed

• Conditions: Postoperative Pain
• Interventions: Drug: 0.9% Sodium-chloride; Drug: Lidocaine

• Registration Number: NCT03030560
• Lead Sponsor: Abdelrady S Ibrahim, MD

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.

Study Timeline

• Study Start: 2015-04
• Primary Completion: 2016-08
• Study Completion: 2016-12
• Study First Submitted: 2017-01-22
• Study First Submitted QC: 2017-01-22
• Study First Posted: 2017-01-25
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-23
• Last Update Posted: 2017-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	0.9% Sodium-chloride	Patients will receive 0.9% Sodium-chloride infusion infusion
Lidocaine group	Lidocaine	Patients will receive lidocaine infusion.

Primary Outcome Measures

Name	Time	Method
numerical rating scale (NRS), pain score.	Postoperative 3 months	Postoperative numerical rating scale (NRS), pain score.

Secondary Outcome Measures

Name	Time	Method
opioid consumption.	Postoperative 24 h	Postoperative opioid consumption.
Serum cortisol.	Postoperative 24 h	Serum cortisol level.

Trial Locations

Locations (1)

Assiut university faculty of medicine; 🇪🇬 Assiut, Egypt