Comparison of the effect of Preoperative Pregabalin and Duloxetine on Postoperative Pain and Cognitive Function After Spinal Surgery

• Register: ANZCTR
• Last refreshed on: 15 July 2019
• Main ID: ACTRN12618000521224
• Date of registration: 09/04/2018
• Prospective Registration: Yes
• Primary sponsor: Basak ALTIPARMAK
• Public title: Comparison of the effect of Preoperative Pregabalin and Duloxetine on Postoperative Pain and Cognitive Function After Spinal Surgery
• Scientific title: Comparison of Preoperative Pregabalin and Duloxetine on Postoperative Pain and Cognitive Function of Adult Patients Undergoing Spinal Surgery
• Date of first enrolment: 22/04/2018
• Target sample size: 90
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12618000521224.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Safety/efficacy;
• Phase: Phase 4

Countries of recruitment

Turkey

Contacts

• Name: Dr Basak ALTIPARMAK

• Name: Dr Basak ALTIPARMAK

Key inclusion & exclusion criteria

Inclusion criteria: Age between 18-65, ASA I, II and III, patients with lumbar disc herniation
Exclusion criteria: Known allergy for study drugs, impaired hepatic and/or renal function, history of chronic use of analgesics, alcohol and drug abuse, morbidly obese patients, patients with a preoperative Montreal cognitive assessment evaluation score under 24

Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Anaesthesiology - Pain management

Postoperative pain after elective decompression laminectomy for lumbar disc herniation ;Cognitive function after elective laminectomy for lumbar disc herniation ;
Postoperative pain after elective decompression laminectomy for lumbar disc herniation
Cognitive function after elective laminectomy for lumbar disc herniation

Mental Health - Studies of normal psychology, cognitive function and behaviour

Intervention(s)

The adult patients scheduled for elective repair of lumbar disc herniation will randomly be divided into three groups. The randomization will be based on a computerized randomization table created by a researcher who will not involve in the study. The patients assigned in the first group will orally receive 75 mg pregabalin one hour before the operation. The dose (75 mg) will be repeated orally at the postoperative 12th and 24th hour, The patients in the second group will orally receive 60 mg duloxetine one hour before the operation. At the postoperative 12th hour, the patients in the second group will receive a matched-place capsule and at the 24th hour, they will orally receive 60 mg duloxetine again. The patients in the third group will orally receive matching placebo capsules at all time-points. One of the researchers who will be blind to the study groups and study drugs will directly observe the patients while receiving the capsules. At the end of the operation, 1 mg/kg intravenous tramadol will be applied to all of the patients for postoperative pain control. All of the patients will be assessed with Montreal Cognitive Assessment evaluations for cognitive function evaluation at the day before the operation and six hours after the operation. Postoperative pain evaluation will be done according to visual analog scale by a researcher who will be blinded to the study groups at the postoperative first minute, 30. minute, first hour, 12. hour, 24. and 48 hour.

Primary Outcome(s)

.To compare the reduction in postoperative first hour pain scores as assessed by 100mm visual analogue scale after preoperative administration of pregabalin 75 mg and duloxetine 60 mg [At postoperative first minute, 30th minute, first hour (primary timepoint), second hour, 12th hour, 24th hour and 48th hour ]

To compare the effect of preoperatively administered pregabalin 75 mg and duloxetine 60 mg on postoperative cognitive functions as assessed by 30 point Montreal Cognitive Assessment Test [At the postoperative 6th hour ]

.To compare the reduction in postoperative 48th hour pain scores as assessed by 100mm visual analogue scale after preoperative administration of pregabalin 75 mg and duloxetine 60 mg [At the postoperative 48th hour ]

Secondary Outcome(s)

To determine the side-effects such as nausea, vomiting and dizziness by directly asking the patient at different timepoints, or hypotension and hypertension by analyzing the nurse-care records at the ward [At the postoperative first minute, 6th, 12th, 24th and 48th hour ]

Secondary ID(s)

Nil Known

Source(s) of Monetary Support

Hacettepe University Hospital

Ethics review

Status: Approved
Approval date:
Contact:

Mugla Sitki Koçman University Training and Research Hospital Institutional Ethics Committee

Results

• Results available: Yes
• Date Posted: 05/06/2019
• Date Completed: 19/05/2018