Comparison of postoperative analgeisa using transdermal buprenorphine vs. fentanyl in patients undergoing lower limb orthopaedic surgeries and lower abdominal surgeiries

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2023/04/052072
• Lead Sponsor: Dr Harjinder Kaur

Brief Summary

Transdermalopioids are newer modality in use for the control of postoperative pain becauseof their noninvasiveness, longer duration of action, sustained blood levels and minimal side effects. The aim of this studyis to evaluate the efficacy of buprenorphine transdermal patch 10 μg·h‑1 and fentanyltransdermal patch 25 μg·h‑1for relief of pain in the  postoperativeperiod in patients undergoing infraumbilical and lower limb orthopaedic surgeries.Our study will be a prospective, interventional, randomized,single blinded clinical study in 60 patients posted for infraumbilical  and lower limb orthopaedic surgeries based onthe inclusion and exclusion criteria mentioned below. Patients will be  randomly allocated into the two groups ‘B’and ‘F’ using sealed envelope technique. Mean Numeric rating scale score, total rescueanalgesic requirement, drug-related adverse effects, and haemodynamic status will be evaluated till48 hours in the postoperative period. The data will then be compiled, tabulatedand statistically analyzed with the latest software.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-04-27
• Study Start: 2023-04-30

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Men and women between 18-60 years, who have given their consent 2.
• ASA classes I and II 3.Posted for infraumbilical surgeries like inguinal hernia repair, haemorroidectomy, hydrocele surgery, surgery for varicose veins and lower limb orthopaedic surgeries.

Exclusion Criteria

• History of allergy to opioids 2.
• History of/ongoing drug abuse 3.
• Patients who are already using a transdermal opioid patch 4.
• Pregnant patients 5.
• Patients taking opioids, NSAIDS, or any pain medication for more than 3 months 6.
• Patients on antiepileptics or antidepressants.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.To compare the efficacy of the study drugs in terms of duration of analgesia in infraumbilical and lower limb orthopaedic surgeries up to 48 hours.	1.To compare the efficacy of the study drugs in terms of duration of analgesia will be measured every 2 hourly upto 12 hours and then 4 hourly upto 48 hours | 2.Total rescue analgesia received in 48 hours.
2.Total rescue analgesia received in 48 hours.	1.To compare the efficacy of the study drugs in terms of duration of analgesia will be measured every 2 hourly upto 12 hours and then 4 hourly upto 48 hours | 2.Total rescue analgesia received in 48 hours.

Secondary Outcome Measures

Name	Time	Method
1. Hemodynamic variability	2. Side effects like pruritus, respiratory depression (SpO2 less than 90% or

Trial Locations

Locations (1)

Guru Nanak Dev Hospital; 🇮🇳 Amritsar, PUNJAB, India

Guru Nanak Dev Hospital

🇮🇳Amritsar, PUNJAB, India

Dr Harjinder Kaur

Principal investigator

9855895452

harjinderkaur5453@gmail.com