Effect of Perioperative Oral Pregabalin in Total Knee Replacement (TKR)

Bahrain Defence Force Hospital

Status and phase: Enrolling; Phase 4

Conditions: Postoperative Pain

Treatments: Procedure: adductor canal block; Drug: Pregabalin 75mg

Study type: Interventional

Funder types: Other

Identifiers

NCT06187922

BDF/R&REC/2023/674 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

120 participants in 2 patient groups

Pregabalin group

Active Comparator group

Description:

this group of patient will receive cap pregabalin 75mg as premedication and will continue as twice daily dose for 72 hrs.

Treatment:

Drug: Pregabalin 75mg

Procedure: adductor canal block

Control group

Sham Comparator group

Description:

This group of patient will not receive cap pregabalin but it will receive standard medical care as routine

Treatment:

Procedure: adductor canal block