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

December 17, 2023 updated by: Mehtash butt, Bahrain Defence Force Hospital

Effect of Perioperative Oral Pregabalin in Total Knee Replacement for Postoperative Pain

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Bahrain
      • Manama, Bahrain, 323
        • Recruiting
        • Bahrain Defence Force
        • Contact:
        • Contact:
        • Principal Investigator:
          • MEHTASH BUTT, FCPS,FCAI
        • Sub-Investigator:
          • Jalal alkhan, FRCA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Pregabalin group
this group of patient will receive cap pregabalin 75mg as premedication and will continue as twice daily dose for 72 hrs.
Drug: Pregabalin 75mg
Group pregabalin will receive cap pregabalin 75mg as premedication and will continue as B.D dose for 72 Hrs.
Other Names:
  • capsule
Procedure: adductor canal block
Both group will receive ultrasound guided Adductor canal block with bupivacaine 0.2% 20-30ml and dexmedetomidine 1mcg/Kg
Other Names:
  • peripheral nerve block
Sham Comparator: Control group
This group of patient will not receive cap pregabalin but it will receive standard medical care as routine
Procedure: adductor canal block
Both group will receive ultrasound guided Adductor canal block with bupivacaine 0.2% 20-30ml and dexmedetomidine 1mcg/Kg
Other Names:
  • peripheral nerve block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale Score (0-10)
Time Frame: 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
72 hours

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bahrain Defence Force Hospital

Investigators

  • Study Chair: Mohammed Al Muharraqi, FRCS,FDSRCS, Bahrain Defence Forces Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

July 30, 2025

Study Registration Dates

First Submitted

December 5, 2023

First Submitted That Met QC Criteria

December 17, 2023

First Posted (Estimated)

January 3, 2024

Study Record Updates

Last Update Posted (Estimated)

January 3, 2024

Last Update Submitted That Met QC Criteria

December 17, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BDF/R&REC/2023/674 (Other Identifier: crown prince training and research centre, Bahrain)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We're still formulating the extended contact plan to follow patients for chronic pain.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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