Postoperative Pain
Conditions
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.
Interventions
DRUGLidocaine
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.
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.
Sponsors
Abdelrady S Ibrahim, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Investigator)
Masking description
Double Blind
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| numerical rating scale (NRS), pain score. | Postoperative 3 months | Postoperative numerical rating scale (NRS), pain score. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| opioid consumption. | Postoperative 24 h | Postoperative opioid consumption. |
| Serum cortisol. | Postoperative 24 h | Serum cortisol level. |
Countries
Egypt
Outcome results
None listed