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

Security Forces Hospital

Status and phase: Enrolling; Phase 4

Conditions: Patients Aged Between 18 and 65years Undergoing Total Knee Arthroplasty

Treatments: Drug: Buprenorphine patch

Study type: Interventional

Funder types: Other

Identifiers

NCT05042648

SecurityFH

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 2 patient groups

Control group (Group A)

No Intervention group

Description:

Group A will receive no intervention

Buprenorphine group (Group B)

Experimental group

Description:

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.

Treatment:

Drug: Buprenorphine patch