Effect of Perioperative Oral Pregabalin in Total Knee Replacement

Last updated: December 17, 2023
Sponsor: Bahrain Defence Force Hospital
Overall Status: Active - Recruiting

Phase

4

Condition

Pain

Post-surgical Pain

Acute Pain

Treatment

Pregabalin 75mg

adductor canal block

Clinical Study ID

NCT06187922
BDF/R&REC/2023/674
BDF/R&REC/2023/674
  • Ages 18-85
  • All Genders

Study Summary

This interventional randomized control trial aim to determine efficacy and safety of Oral pregabalin in improving after surgery pain control in patients undergoing total knee replacement surgeries under regional anesthesia. We'll compare the efficacy of pregabalin between two groups, pregabalin group and control group on the basis of their opioid consumption after knee operation.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age between 18 to 85 year
  2. Elective Regional anesthesia.
  3. Able to follow study protocol

Exclusion

Exclusion Criteria:

  1. ASA -IV
  2. Age <18 & > 85 years
  3. Patients on pregabalin for chronic neuropathic pain.
  4. Patient under General anesthesia
  5. Patients with chronic liver failure
  6. Patients with chronic renal failure on Hemodialysis
  7. Patients on opioid (>3 month)
  8. Patient with complicated knee surgery

Study Design

Total Participants: 120
Treatment Group(s): 2
Primary Treatment: Pregabalin 75mg
Phase: 4
Study Start date:
September 01, 2023
Estimated Completion Date:
July 30, 2025

Study Description

After obtaining approval from the institutional ethical committee and informed written consent, 120 patients fulfilling the inclusion criteria will be included in this study. The patients will be randomly assigned into two equal groups; Group P: Pregabalin group and Group C: control group. Group P will receive oral capsule pregabalin 75mg one hour preoperatively and Group C will not receive any premedication preoperatively.

Intraoperatively both groups will receive inj. Midazolam 2 mg before subarachnoid block with hyperbaric Bupivacaine 0.5% 2.5-3ml and fentanyl 15mcg in the operation theatre (OT). Both groups will also receive parecoxib 40mg IV and paracetamol 1G Intravenous (IV) as part of multimodal analgesia. Both groups will receive dexamethasone 8mg IV prophylactically.

Postoperatively both groups will receive Ultrasound guided Adductor canal saphenous Nerve block in the PACU with 0.2% Bupivacaine 20-30ml & dexmeditomidine1.0mcg/kg. Group P will receive oral capsule pregabalin 75 mg Q12hourly from the 1st dose for next 60 hours. Group C will not receive any medication. Both groups will receive paracetamol 1G IV Q6Hourly and Rescue Analgesia will be provided with oral oxycodone 5mg TDS and Morphine PCA, in escalating manner as per patient requirement.

for 24 hrs. After 24 hours Both groups with receive tab paracetamol1 g Q4hourly, ibuprofen 400 Q8hourly along with Tab oxycodone as PRN Q8Hourly and PCA morphine.

Connect with a study center

  • Bahrain Defence Force

    Manama, 323
    Bahrain

    Active - Recruiting

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