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CWI and Discharge After Breast Cancer Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02897934
Recruitment Status : Completed
First Posted : September 13, 2016
Last Update Posted : February 2, 2021
Sponsor:
Information provided by (Responsible Party):
Brian Declan O'Donnell, University College Cork

Brief Summary:

The objectives of this work are threefold:

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

Condition or disease Intervention/treatment
Breast Cancer Pain Drug: Bupivacaine continuous infusion

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Study Type : Observational
Actual Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Continuous Wound Infiltration and 23 Hour Discharge Following Major Breast Cancer Surgery
Study Start Date : August 2016
Actual Primary Completion Date : January 1, 2018
Actual Study Completion Date : July 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer


Intervention Details:
  • Drug: Bupivacaine continuous infusion
    The use of continuous wound infusion of bupivacaine
    Other Name: marcain


Primary Outcome Measures :
  1. Pain [ Time Frame: 24 hours, 48 hours ]
    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.


Secondary Outcome Measures :
  1. Quality of recovery at 24 & 48 hours (QoR 40) [ Time Frame: 24 hours, 48 hours ]
    The quality of postoperative recovery from surgery and anaesthesia will be scored on the first and second postoperative day using the validated QoR 40 score. These metrics will be recorded on a bespoke Android App.

  2. Analgesic Consumption at 24 & 48 hours [ Time Frame: 24 hours, 48 hours ]
    The quantity of analgesics consumed on the first and second post operative day will be recorded, on a bespoke Android App.

  3. Wound drain output at 24 & 48 hours [ Time Frame: 24 hours, 48 hours ]
    Wound drain serous fluid output will be measured as is usual by the patient. These metrics will be recorded on a bespoke Android App.

  4. patient satisfaction [ Time Frame: 48 hours ]
    Patient satisfaction with their perioperative experience will be measured on a likert-type scale using a bespoke android app.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women undergoing mastectomy and mastectomy with axillary surgery.
Criteria

Inclusion Criteria:

Women undergoing any one of:

mastectomy mastectomy with axillary lymph node clearance mastectomy with axillary lymph node sampling

Exclusion Criteria:

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02897934


Locations
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Ireland
Brian O'Donnell
Cork, Ireland
Sponsors and Collaborators
University College Cork
Investigators
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Principal Investigator: Brian O'Donnell, MD Cork University Hospital
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Responsible Party: Brian Declan O'Donnell, Consultant Anaesthetist and Clinical Senior Lecturer, University College Cork
ClinicalTrials.gov Identifier: NCT02897934    
Other Study ID Numbers: ECM4(h)031115
First Posted: September 13, 2016    Key Record Dates
Last Update Posted: February 2, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Only pooled data will be shared/reported
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents