CWI and Discharge After Breast Cancer Surgery

NCT02897934 | Completed

• 1 other identifier: ECM4(h)031115
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The objectives of this work are threefold:

1. 1.To evaluate the analgesic efficacy of CWI in women discharged within 23 hours of major breast cancer surgery
2. 2.To evaluate objective indices of patient recovery following anaesthesia and surgery in a 23 hour model of care
3. 3.To evaluate patient satisfaction with their care pathway

Conditions

Breast Cancer; Pain

Outcome Measures

Primary Outcomes (1)

• Pain

  Pain will be recorded at at 24 and 48 hours using a slide-rule page on bespoke Android App. Pain will be recorded in a manner analogous to a visual analog scale 0 = No pain, 100 = Worst imaginable pain. Participants will be prompted on the first and second postoperative days to score their worst level of pain.

  24 hours, 48 hours

Secondary Outcomes (4)

• Quality of recovery at 24 & 48 hours (QoR 40)

  24 hours, 48 hours

• Analgesic Consumption at 24 & 48 hours

  24 hours, 48 hours

• Wound drain output at 24 & 48 hours

  24 hours, 48 hours

• patient satisfaction

  48 hours

Interventions

Bupivacaine continuous infusion DRUG

The use of continuous wound infusion of bupivacaine

Also known as: marcain

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women undergoing mastectomy and mastectomy with axillary surgery.

You may qualify if:

• Women undergoing any one of:
• mastectomy mastectomy with axillary lymph node clearance mastectomy with axillary lymph node sampling

You may not qualify if:

• Refusal to participate; Allergy to Bupivacaine; Pre-existing pain conditions; Regular use of opioid analgesia; Pregnancy; Uncontrolled Diabetes; Uncontrolled Thyroid disorder; Severe cardiac, renal or hepatic disease ; Bilateral surgery; Planned discharge \>23 hours; Travel time from the admitting hospital \>45 minutes; Absence of intellectual capacity to consent

Sponsors & Collaborators

• University College Cork: lead

Study Sites (1)

Brian O'Donnell

Cork, Ireland

Location

MeSH Terms

Conditions

Breast Neoplasms; Pain

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Brian O'Donnell, MD

  Cork University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Anaesthetist and Clinical Senior Lecturer

Study Record Dates

• First Submitted: August 31, 2016
• First Posted: September 13, 2016
• Study Start: August 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: July 31, 2018
• Last Updated: February 2, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)