Effectiveness of Buprenorphine Patch applied on skin for post-operative pain in patients undergoing Knee Replacement surgeries.

Efficacy of two different doses of Transdermal Buprenorphine Patch for Analgesia in patients undergoing Total Knee Replacement surgery under Spinal Anaesthesia – A Randomized Controlled Trial. - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/05/066648

Enrollment

Registered

2024-05-02

Start date

Unknown

Completion date

Unknown

Last updated

2024-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Transdermal Buprenorphine Patch for Analgesia: Group 1- Transdermal Buprenorphine Patch of 5 mcg/hour. Control Intervention1: Transdermal Buprenorphine Patch for Analgesia: Group 2- Tra

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients undergoing Total Knee Replacement surgery under Spinal Anaesthesia. 2. American Society Of Anesthesiologists (ASA) physical status I and II. 3. 18 - 70 years of age of either gender.

Exclusion criteria

Exclusion criteria: 1. Allergy to Buprenorphine 2. Opioid dependency for more than 3 months 3. Alcoholic Liver Disease, Chronic Kidney Disease 4 and 5 4. Pregnant women 5. Malignancy 6. Patient on any anti-depressants (or) anti-convulsant 7. Morbidly Obese (BMI more than 35)

Design outcomes

Primary

Measure	Time frame
Total doses of post-operative rescue analgesia requirement.Timepoint: Up to 72 hours post-operatively.	—

Secondary

Measure	Time frame
1. Pain Score by 11-Point Numerical Rating Scale (NRS) at 8th, 24th, 48th and 72nd hours post-operatively. 2. Sedation Score by Ramsay Sedation Score (RSS) at 8th, 24th, 48th and 72nd hours post-operatively. 3. Incidence of adverse effects like Post-Operative Nausea and Vomiting (PONV), Pruritus, Respiratory Depression and Urinary Retention. 4. Hemodynamic Variations like Mean Arterial Pressure (MAP) and Heart Rate (HR). 5. Quality of Recovery Index is calculated based on 15 questions each carrying 0-10 points totalling up to 0-150 and patients are divided into poor, moderate, good and excellent recovery for 0-89, 90-121, 122-135 and 136-150 respectively at 24th, 48th and 72nd hours.Timepoint: 1. 11-Point Numerical Rating Scale and Ramsay Sedation Scale score at 8th, 24th, 48th and 72nd hour. 2. Quality of Recovery Index at 24th, 48th and 72nd hours.	—

Measure

Time frame

1. Pain Score by 11-Point Numerical Rating Scale (NRS) at 8th, 24th, 48th and 72nd hours post-operatively. 2. Sedation Score by Ramsay Sedation Score (RSS) at 8th, 24th, 48th and 72nd hours post-operatively. 3. Incidence of adverse effects like Post-Operative Nausea and Vomiting (PONV), Pruritus, Respiratory Depression and Urinary Retention. 4. Hemodynamic Variations like Mean Arterial Pressure (MAP) and Heart Rate (HR). 5. Quality of Recovery Index is calculated based on 15 questions each carrying 0-10 points totalling up to 0-150 and patients are divided into poor, moderate, good and excellent recovery for 0-89, 90-121, 122-135 and 136-150 respectively at 24th, 48th and 72nd hours.Timepoint: 1. 11-Point Numerical Rating Scale and Ramsay Sedation Scale score at 8th, 24th, 48th and 72nd hour. 2. Quality of Recovery Index at 24th, 48th and 72nd hours.

—

Countries

India

Contacts

Public ContactDr T Rajmohan Rao

Kalinga Institute of Medical Sciences

dr.sapnadas88@gmail.com9078826164

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026