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OpenTrials
Completed

NCT Number: NCT03030560

Longterm Postoperative Analgesia, Intravenous Lidocaine Infusion

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

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Assiut university faculty of medicine

Asyut, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lidocaine

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.

Other names: Xylocaine

0.9% Sodium-chloride

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.

Other names: Normal saline

Primary outcomes

  1. numerical rating scale (NRS), pain score.

    Time frame: Postoperative 3 months

    Postoperative numerical rating scale (NRS), pain score.

Secondary outcomes

  1. opioid consumption.

    Time frame: Postoperative 24 h

    Postoperative opioid consumption.

  2. Serum cortisol.

    Time frame: Postoperative 24 h

    Serum cortisol level.

Sponsors and collaborators

Lead sponsor

Abdelrady S Ibrahim, MD

Other

Registry information

Official study title

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

Acronym: Lidocaine

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jan 25, 2017
Registry last updated
Nov 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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