Comparison of ropivacaine (a local anaesthetic) and ropivacaine with fentanyl (an analgesic) injected adjacent to thoracic vertebra to provide pain relief in patients with multiple rib fractures

Phase 4

Completed

• Conditions: Unilateral multiple rib fractures

• Registration Number: CTRI/2012/12/003187
• Lead Sponsor: University College of Medical Sciences and Guru Teg Bahadur Hospital

Brief Summary

This was a prospective, randomized, double blind, parallel group trial to evaluate and compare the analgesic effect of continuous infusions of either ropivacaine 0.375% with adrenaline 5 µg/ml or a combination of fentanyl 2 µg/ml and ropivacaine 0.2% with adrenaline 5 µg/ml in patients with unilateral multiple rib fractures. Drug related side effects, if any, and the outcome in terms of length of ICU and hospital stay and pulmonary complications in the two groups were also compared.xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-18
• Last Update Posted: 2013-09-29

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Patients having three or more unilateral fractured ribs.

Exclusion Criteria

• Unconscious patients • Patients with unstable cardiac status or severely altered mental status • Known liver/kidney disease • Known allergy to local anaesthetic drugs • Infection at site of needle insertion • Pre-existing spinal deformity • Patients having significant trauma outside chest wall, e.g. acute spine or pelvic fracture, severe traumatic brain or spinal cord injury or abdominal visceral injuries.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rescue analgesic (morphine) requirement	Throughout study period till VAS score at rest and on coughing was not more than 10 to 15 mm for more than 8 hours

Secondary Outcome Measures

Name	Time	Method
• VAS pain scores at rest and on coughing	• Respiratory rate

Trial Locations

Locations (1)

Department of Anaesthesiology and Critical Care, UCMS and GTB Hospital; 🇮🇳 East, DELHI, India

Department of Anaesthesiology and Critical Care, UCMS and GTB Hospital

🇮🇳East, DELHI, India

Dr Medha Mohta

Principal investigator

9868399626

medhamohta@hotmail.com