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

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.

Study Overview

• Status: Recruiting
• Conditions: Patients Aged Between 18 and 65years Undergoing Total Knee Arthroplasty
• Intervention / Treatment: Drug: Buprenorphine patch

Detailed Description

Effective postoperative pain control is a major challenge to the treating surgeons and Anaesthetists. Most opioids cause side effects such as sedation, nausea, vomiting, and respiratory depression. A number of other modalities have also been recommended for treatment of post-operative pain, including epidural infusion, patient-controlled analgesia, peripheral nerve block, continuous intra-articular infusion and local intra-articular analgesic injection. However, all of these treatments are invasive and aggressive and are potentially associated with regional bleeding, infection and nerve damage.

In the study by Londhe et al, all patients received peri-articular local anesthetic infiltration and then epidural/femoral nerve block infusion for 72 hours postoperatively. Group A received the TDB patch 5 mcg applied at the end of surgery. Group B received a combination of paracetamol and tramadol. They concluded that TDB patch is more efficacious in reducing postoperative pain after TKA surgery and can be safely used with fewer systemic side effects when compared to conventional analgesics.

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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Anwar ul Huda, FRCA; Phone Number: 00966118024331; Email: hudaanwar90@yahoo.com

Study Locations

• Saudi Arabia
  • Riyadh, Saudi Arabia
    • Recruiting
    • Security Forces Hospital Program
    • Contact: Anwar ul Huda, FRCA; Phone Number: 00966502654719; Email: hudaanwar90@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group (Group A); Group A will receive no intervention
Experimental: Buprenorphine group (Group B); 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
morphine (PCA) consumption	24 hours morphine consumption	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain score measured by Numeric rating scale (NRS)	NRS pain score at 15th minute, 30th minute and 1st, 2nd, 6th, 12th, 18th and 24th hours both at rest and on movement	15th minute, 30th minute and 1st, 2nd, 6th, 12th, 18th and 24th hours
Rescue analgesic use	rescue analgesic use within the first 24h.	24 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative nausea and vomiting	The severity of both nausea and sedation will be assessed by patients on a 4 point scale (none, mild, moderate, and severe). Nurses will note any vomiting in the recovery room or on the ward	First 24 hours
Patient satisfaction	patient satisfaction score will also be measured on score of 1-10.	24 hours
range of motion (ROM)	The range of motion (ROM) will be measured by the same physical therapist using a goniometer pre-operatively and on PD 1	24 hours

Collaborators and Investigators

• Sponsor: Security Forces Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Anticipated): December 15, 2023
• Study Completion (Anticipated): December 15, 2023

Study Registration Dates

• First Submitted: September 4, 2021
• First Submitted That Met QC Criteria: September 4, 2021
• First Posted (Actual): September 13, 2021

Study Record Updates

• Last Update Posted (Actual): April 4, 2023
• Last Update Submitted That Met QC Criteria: April 1, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Narcotic Antagonists; Buprenorphine
• Other Study ID Numbers: SecurityFH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: It will be shared on request
• IPD Sharing Time Frame: 2 years
• IPD Sharing Access Criteria: On request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No