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

Comparison of Preoperative Pregabalin and Duloxetine on Postoperative Pain and Cognitive Function of Adult Patients Undergoing Spinal Surgery

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618000521224
Acronym
PDT
Enrollment
94
Registered
2018-04-09
Start date
2018-04-22
Completion date
2018-05-18
Last updated
2019-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The primary aim of this study is to compare the effect of preoperative pregabalin and duloxetine on postoperative pain scores and cognitive functions of the patients undergoing spinal surgery. Our hypothesis is that both pregabalin and duloxetin will attenuate postoperative pain scores when compared to placebo group. Our secondary aim is to observe the side-effects related to study drugs. Our hypothesis is that the study drugs will not cause significant side-effects in the postoperative period.

Interventions

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 du

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.

Sponsors

Basak ALTIPARMAK
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026