Pain relief after operation by medication through tube placed beneath the skin in cardiac surgical patients

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2022/07/044245
• Lead Sponsor: LSNagaswetha

Brief Summary

Cardiac surgery induces severe postoperative pain, resulting in impairment of pulmonary function, increased duration of hospital stay with increased morbidity and mortality1. Inadequate pain control reduces the capacity to cough, mobility, increases the frequency of atelectasis and prolongs recovery2 . A major cause of pain after cardiac surgery is the median sternotomy particularly on the first two postoperative days2 . Sternotomy, rib retraction, conduit harvest and drain tubes are some of the sources of pain in cardiac surgery1 . The most often used analgesics in these patients are parenteral opioids which can lead to undesirable respiratory depression, nausea and vomiting2Therefore,  we  are  planning  a  prospective, randomised, controlled, study on the efficacy and safety of infusing long-acting local anaesthetic drugs vs intermittent boluses of local anaesthetic administration into the median sternotomy wound in adult  patients  after  cardiac  surgery. we hypothesized that this intermittent bolus administration of local anaesthetic would significantly improve pain control as that of continuous infusion, as evidenced by the reduced need for postoperative systemic analgesic

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-07-18
• Study Start: 2022-07-25

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 171

Inclusion Criteria

• age groups 18-65 years of either sex 2.
• category 1 or 2 under CARE score (Cardiac Anaesthesia Risk Evaluation score) are included in the study viz.
• coronary artery disease with TVD and normal LV function, all valve replacement surgeries, ASD and VSD closure.

Exclusion Criteria

• emergency surgery 2.
• Redo surgeries 3.
• Preoperative inotropic support 4.
• preoperative poor left ventricular function (EF <40%) 5.
• clinically significant kidney or liver disease 6.
• COPD patients, uncontrolled DM 7.
• morbidly obese patients 8.
• Low cardiac output syndrome 9.
• patients allergic to local anaesthetics 10.
• preexisting coagulopathy 11.
• postoperative hemodynamic instability 12.
• If surgeon refuses.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the efficacy of ropivacaine infiltration by pre-sternal multi-orifice catheter for post-sternotomy pain relief in adult patients undergoing cardiac surgery based on Visual Analog Score (VAS) and rescue analgesic consumption.	Visual analog scale assessment for 48hours

Secondary Outcome Measures

Name	Time	Method
Time to extubation ➢ Postoperative respiratory parameters ➢ Length of ICU stay ➢ Incidence of wound infection	171

Trial Locations

Locations (1)

AIIMS; 🇮🇳 Delhi, DELHI, India

AIIMS

🇮🇳Delhi, DELHI, India

LSNaga swetha

Principal investigator

8297389386

swethasweety634@gmail.com