Plain English Summary
Trial website
Contact information
Type
Scientific
Primary contact
Dr Mark Piper
ORCID ID
Contact details
Department of Anaesthesia
Wansbeck General Hospital
Woodhorne Lane
Ashington
NE63 9JJ
United Kingdom
-
mark.piper@nhct.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Additional pain control using Surgically Placed Wound Catheters (SPWC) and local anaesthetic infusion after mastectomy and breast reconstruction a randomized controlled trial
Acronym
SPWC
Study hypothesis
Usage of surgically placed wound catheter and local anaesthetic infusion will improve pain relief and comfort after breast surgery
Ethics approval
Newcastle 2 Ethics committee ref: 11/NE/0131
Study design
Type A: Oral and parenteral opioid based analgesia for breakthrough pain
Type B: Oral and parenteral opioid based analgesia for breakthrough pain and in addtion wound catheter placement
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Condition
Breast cancer, pain relief, wound catheter, local anaesthetic infusion
Intervention
Surgically placed wound catheter for group B PAJUNK; infiltralong; and local anaesthetic infusion using Ambit; infusion pump and required
Intervention type
Drug
Phase
Not Applicable
Drug names
Opioids
Primary outcome measure
1. Pain scores (daily and average) following the procedure
2. Total opioid requirements
3. Days opioid free
Secondary outcome measures
Side effects of opioid based analgesics such as nausea, drowsiness and constipation
Overall trial start date
01/09/2011
Overall trial end date
31/08/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Mastectomy alone
2. Mastectomy + sentinel lymph node biopsy (SLNB)
3. Mastectomy + axillary nodes dissection (AND)
4. Mastectomy + reconstruction
5. Reconstruction alone using implant
6. Reconstruction using Latissmus dorsi (LD) flap
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
100
Participant exclusion criteria
1. Allergy to local anaesthetic
2. Inability/refusal to perform self assessment
3. Inability to consent due to any reason
4. Has had one of the following procedures:
4.1. All wide local excisions (WLE) and Further WLE
4.2. Only axillary procedure
4.3. Mastopexy as additional procedure
4.4. Readjusting the implants only
Recruitment start date
01/09/2011
Recruitment end date
31/08/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Wansbeck General Hospital
Ashington
NE63 9JJ
United Kingdom
Sponsor information
Organisation
Northumbria Healthcare NHS Foundation Trust (UK)
Sponsor details
Rake Lane
North Shields
NE27 0BF
United Kingdom
+44 (0)844 811 8111
caroline.potts@NHCT.nhs.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Northumbria Healthcare NHS Foundation Trust - Breast Cancer Care Fund (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list