Evaluation of analgesic efficacy of pre operative buprenorphine transdermal patch for acute post operative pain management in patients undergoing laparoscopic upper abdominal surgeries in a tertiary care hospital

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Evaluation of analgesic efficacy of pre operative buprenorphine transdermal patch for acute post operative pain management in patients undergoing laparoscopic upper abdominal surgeries in a tertiary care hospital

Principal Investigator Dr GANGA VIKAS Postgraduate in Pharmacology Guide Dr Anitha P Professor Department of Pharmacology Co Guide Dr Suresh C HOD & ProfessorDepartment of Anesthesiology

NEED FOR STUDY Effective postoperative pain management is a cornerstone of enhanced recovery after surgery particularly in minimally invasive procedures like laparoscopic surgeries.

Despite being less invasive than open surgery laparoscopic surgeries can still result in significant postoperative pain

1 Traditionally used analgesics in the postoperative setting include;parenteral Nonsteroidal anti inflammatory drugs NSAIDs such as diclofenac or ibuprofen, opioids such as tramadol which provide good analgesia but are often associated with gastrointestinal side effects renal impairment convulsions respiratory depression and bleeding risks especially in high risk patients

2 Given the limitations of traditional analgesic regime and the need to improve patient comfort and outcomes it is essential to explore and validate newer modalities like transdermal buprenorphine in postoperative pain management However there is limited data on the efficacy and safety of buprenorphine patches in the Indian rural setting for laparoscopic procedures

3 This study is a Evaluation of analgesic efficacy of pre-operative buprenorphine transdermal patches for acute post operative pain management in patients undergoing laparoscopic upper abdominal surgeries in a tertiary care hospital The findings of this study will help in clinical decision making and improve patient care

Objectives of the study To assess the efficacy of preoperative buprenorphine transdermal patches for acute post operative pain in patients undergoing upper abdominal laparoscopic surgeries

To assess the safety of preoperative buprenorphine transdermal patches for acute post operative pain in patients undergoing upper abdominal laparoscopic surgeries

Materials and Methods Study Area  Department of Anesthesia Sri Siddhartha Institute of Medical Sciences and Research Centre T Begur

Source of data  All patients undergoing upper abdominal laparoscopic surgeries in Sri Siddhartha Institute of Medical Sciences and Research Centre T Begur will be studied.

Study design A prospective cohort study

Sampling Technique Purposive sampling

Study period 18 months

Inclusion Criteria Adult patients aged 18 to 65 years

Patients scheduled for elective laparoscopic upper abdominal surgeries

Patients who are willing to give consent to participate in the study

Exclusion Criteria Known hypersensitivity to buprenorphine or opioids

Patient with generalized skin conditions

Patients with significant hepatic or renal impairment

Patients with respiratory disorders

History of chronic pain or long-term opioid use

Pregnant or lactating women

Methodology The present study will be conducted after obtaining the permission of institutional ethics committee clearance from SSIMS&RC t Begur Bangalore Rural

All the basic necessary clinical details will be obtained from the patient. Informed written consent will be obtained from all the study subjects Local examination at the transdermal patch application site and general examination will be done With all aseptic precautions the skin will be cleaned with normal saline and the buprenorphine transdermal patch 5mcg hr will be applied on intact healthy skin at the supraclavicular or the suprascapular area 1 hour before the surgery to ensure adequate plasma levels during the postoperative period The patch will be maintained for up to 3 days depending on the patients pain levels and clinical judgment

Post operative pain will be assessed using the VAS Visual analogue scale very hour for the first 8 hours and 2 hours for the next 16 hours and once in a day for the next 2 days

If patients experience breakthrough pain  VASmore than 5 rescue parenteral analgesics like paracetamol diclofenac VAS between 5 to 8 and tramadol VAS more than eight will be administered depending on the severity of pain and patient specific factors

The patch will be removed after 3 days or earlier if

The patient reports no pain for a sustained period

Adverse effects necessitate discontinuation

Haemodynamic status BP Pulse rate SPO2 Respiratory rate along with VAS will be monitored for the first 3 days postoperatively

Any adverse effects during the course of the study will be noted down

Sample size

85