SUBpectoral Local anaesthetic Infusion following MastEctomy - version 1 (SUBLIME)

Not Applicable

Completed

• Conditions: Breast Cancer; Cancer; Malignant neoplasm of breast

• Registration Number: ISRCTN46621916
• Lead Sponsor: Royal Cornwall Hospitals NHS Trust (UK)

Brief Summary

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25270861

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-09-10
• Study Completion: 2016-08-14
• Last Update Posted: 26 June 2019

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 160

Inclusion Criteria

1. All women presenting for unilateral mastectomy surgery at the Royal Cornwall Hospitals NHS Trust and Royal Devon and Exeter NHS Foundation Trust
2. Female
3. Aged 18 years and over
4. Scheduled for unilateral mastectomy with or without axillary involvement

Exclusion Criteria

1. Inability to give informed consent
2. Primary reconstructive surgery
3. Hypotension, hypovolaemia or any form of shock
4. Known allergy or sensitivity to local anaesthetic agents, morphine, paracetamol or ondansetron
5. Pregnancy
6. Daily opioid analgesic use
7. Inability to understand or use a PCA device
8. Inability to understand or complete the visual analogue assessment tools
9. Concurrent participation in another interventional study that might conflict with this trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified