A comparative study of two different opioids in two different routes for postoperative analgesia in patients undergoing major abdominal surgeries

Phase 2

Not yet recruiting

Conditions: post operative patients

Registration Number: CTRI/2024/03/064238

Lead Sponsor: Bangalore medical college and research institute

Brief Summary: Post operative pain is very common in major abdominal surgeries, and one of the major concerns for the patient undergoing major surgery. Pain in the first few days after surgery can lead to delayed ambulation, increase in cardiopulmonary and thrombotic morbidity as well the development of chronic pain.

Appropriate pain relief leads to shortened hospital stays, reduced hospital costs, increased patient satisfaction. Opioid is generally regarded as an important part of multimodal, perioperative analgesia, especially for moderate to severe pain. â€¢Buprenorphine is a semisynthetic opioid derivative of thebaine, being a potent and safe analgesic (75-100 times greater than that of morphine) at 5-10% receptors occupancy, causing less respiratory depression. Time to attain minimum therapeutic concentration after transdermal patch is 21 hours. Fentanyl is a potent synthetic opioid similar to morphine, but produces analgesia to great extent. IV Fentanyl has an appropriate effectiveness in acute pain relief and suitable doses have comparable effects to morphine, with shorter onset of action being 30-60 mins, onset of action being 60 seconds.

Traditional and most common approach of post operative analgesia includes usage of opioid drug like morphine or fentanyl taken intravenously.

Transdermal opioids are newer modality in use for the control of postoperative pain, because of its non invasiveness, longer duration of action, sustained blood levels and with minimal side effects

There fore, the need of this study is to compare between traditional and standard approach- Intravenous fentanyl versus newer modality transdermal buprenorphine in the management of post operative pain, as there are very few studies quoted about them.

our study is randomized study conducted in bangalore medical college and research institute

conducted in 30 patients, 15 patients receiving transdermal buprenorphine as post operative analgesia and other 15 receiving intravenous fentanyl as postoperative analgesia.

postoperatively pain will be asssessed by visual analogue scale, ramsay sedation score, hemodynamic parameters.

adverse effects caused by both the groups noted.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 30

Inclusion Criteria

Patients with weight 40-80kgs.
Patients scheduled for open elective intraperitoneal abdominal surgeries under general anaesthesia Patients giving informed written consent.
Patients belonging to ASA I, II.

Exclusion Criteria

1.Patients who refused to give informed written consent.
2.Patients with ASA physical status III or more.
3.Patients with known cardiac and pulmonary complications.
4.Patients with known allergy to opioids.
5.Patients with mental illness.
6.Pregnants and breastfeeding females.
Surgeries of duration > 3 hours.
Surgeries including surgical incision extended 5 cm above the umbilicus.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
visual analogue scale	Post operative day 1 to day 3

Secondary Outcome Measures

Name	Time	Method
ramsay sedation scale	hemodynamic parameters

Trial Locations

Locations (1): Bangalore medical college and research institute
🇮🇳
Bangalore, KARNATAKA, India
Bangalore medical college and research institute
🇮🇳Bangalore, KARNATAKA, India
Dr Sahana BV
Principal investigator
9686177897
sahanavenkatramu1997@gmail.com