Longterm Postoperative Analgesia, Intravenous Lidocaine Infusion

Postoperative Pain Clinical Trial

— Lidocaine  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03030560
• Other study ID #: IRB0000871239
• Status: Completed
• Phase: Phase 2
• First received: January 22, 2017
• Last updated: November 23, 2017
• Start date: April 2015
• Est. completion date: December 2016

Study information

• Verified date: November 2017
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
Egypt	Assiut university faculty of medicine	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Abdelrady S Ibrahim, MD

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	numerical rating scale (NRS), pain score.	Postoperative numerical rating scale (NRS), pain score.	Postoperative 3 months
Secondary	opioid consumption.	Postoperative opioid consumption.	Postoperative 24 h
Secondary	Serum cortisol.	Serum cortisol level.	Postoperative 24 h