Effect of Perioperative Oral Pregabalin in Total Knee Replacement

Phase 4

Recruiting

• Conditions: Postoperative Pain
• Interventions: Drug: Pregabalin 75mg; Procedure: adductor canal block

• Registration Number: NCT06187922
• Lead Sponsor: Bahrain Defence Force Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2023-09-01
• Status Verified: 2023-12
• Study First Submitted: 2023-12-05
• Study First Submitted QC: 2023-12-17
• Last Update Submitted: 2023-12-17
• Study First Posted: 2024-01-03
• Last Update Posted: 2024-01-03
• Primary Completion: 2025-06-30
• Study Completion: 2025-07-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pregabalin group	Pregabalin 75mg	this group of patient will receive cap pregabalin 75mg as premedication and will continue as twice daily dose for 72 hrs.
Pregabalin group	adductor canal block	this group of patient will receive cap pregabalin 75mg as premedication and will continue as twice daily dose for 72 hrs.
Control group	adductor canal block	This group of patient will not receive cap pregabalin but it will receive standard medical care as routine

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale Score (0-10)	72 hours	visual analogue scale score at 4 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours, 60 hours and 72 hours. minimum score mean good outcome

Secondary Outcome Measures

Name	Time	Method
Richmond Agitation Sedation Scale score {(+4) -0- (-5)}	72 hours	Richmond Agitation Sedation Scale score at 4 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours, 60 hours and 72 hours. score +/-1 to 0 means good outcome.
Visual Analogue Sedation score at 1st Continuous Passive Movement	with in 24 hours	visual analogue score at 1st continuous passive movement
Time of 1st analgesia request	within 24 hours	Estimation of time for 1st complaint of pain
Incident of Hypotension	within 24 hours	Incident of reduced blood pressure below baseline
Total opioid consumption	within 72 hours	Total opioid consumption in 72hours: Oxycodone/Morphine
Patient satisfaction	within 72 hours	Patient satisfaction at 72 hours: rated as numeric 1-5 (1=not satisfied, 5=fully satisfied)
Incident of bradycardia	within 24hours	Incident of reduction in Heart rate in 1st 24 Hours

Trial Locations

Locations (1)

Bahrain Defence Force; 🇧🇭 Manama, Bahrain