Role of Preoperative Transdermal Buprenorphine Patch in Reducing Postoperative Opioids Consumption in Patients Undergoing Total Knee Arthroplasties - A Randomised Controlled Trial.

NCT05042648 | Unknown Phase 4 DMC

• 1 other identifier: SecurityFH
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This study will help us in understanding the role of transdermal buprenorphine patch in reducing consumption of opioids in patients undergoing total knee replacement. The objective of our study is to investigate the role of preoperative TDB patch in reducing postoperative opioids consumption in patients undergoing total knee arthroplasties. Patients aged between 18 and 65years, scheduled to undergo total knee arthroplasty with an ASA score of 1 to 3 will be included in the study.

Conditions

Patients Aged Between 18 and 65years Undergoing Total Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

• morphine (PCA) consumption

  24 hours morphine consumption

  24 hours

Secondary Outcomes (2)

• Pain score measured by Numeric rating scale (NRS)

  15th minute, 30th minute and 1st, 2nd, 6th, 12th, 18th and 24th hours

• Rescue analgesic use

  24 hours

Other Outcomes (3)

• Postoperative nausea and vomiting

  First 24 hours

• Patient satisfaction

  24 hours

• range of motion (ROM)

  24 hours

Study Arms (2)

Control group (Group A)

NO INTERVENTION

Group A will receive no intervention

Buprenorphine group (Group B)

EXPERIMENTAL

Group B will receive buprenorphine patch of 10 mg (sustained release of 10 µg/h) applied either on chest or on outer side of arm 12 h before surgery. The transdermal buprenorphine patch should be applied to intact skin on the flat surfaces of the upper outer arm, upper chest, upper back, or the side of the chest.

Drug: Buprenorphine patch

Interventions

Buprenorphine patch DRUG

Group B will receive buprenorphine patch of 10 mg (sustained release of 10 µg/h) applied either on chest or on outer side of arm 12 h before surgery. The transdermal buprenorphine patch should be applied to intact skin on the flat surfaces of the upper outer arm, upper chest, upper back, or the side of the chest. The skin should be dry, clean, non irritated, non hairy (hair should be trimmed with scissors, not shaved), and without large scars.

Buprenorphine group (Group B)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged between 18 and 65years, scheduled to undergo total knee arthroplasty with an ASA score of 1 to 3 will be included in the study.

You may not qualify if:

• Patients who will refuse enrollment or later request removal from the study, those who are unable to give informed consent and patients with contraindications for regional anesthesia like known allergy to local anesthetics, bleeding diathesis, use of anticoagulants or corticosteroids, inability to operate patient controlled analgesia (PCA) system, psychiatric disorders or use of psychiatric medications and known allergy to TDB patch.

Sponsors & Collaborators

• Security Forces Hospital: lead

Study Sites (1)

Security Forces Hospital Program

Riyadh, Saudi Arabia

RECRUITING

Central Study Contacts

Anwar ul Huda, FRCA

CONTACT

00966118024331; hudaanwar90@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Study Record Dates

• First Submitted: September 4, 2021
• First Posted: September 13, 2021
• Study Start: December 1, 2021
• Primary Completion: December 15, 2023
• Study Completion: December 15, 2023
• Last Updated: April 4, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 2 years
• Access Criteria: On request

Locations

SA (1)