Additional pain control using Surgically Placed Wound Catheters (SPWC) and local anaesthetic infusion after mastectomy and breast reconstruction

ISRCTN	ISRCTN68960543
DOI	https://doi.org/10.1186/ISRCTN68960543
Secondary identifying numbers	N/A

Submission date: 06/07/2011
Registration date: 25/08/2011
Last edited: 11/05/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

http://cancerhelp.cancerresearchuk.org/trials/a-trial-looking-pain-control-after-breast-cancer-surgery

Study website

Contact information

Dr Mark Piper
Scientific

Department of Anaesthesia
Wansbeck General Hospital
Woodhorne Lane
Ashington
NE63 9JJ
United Kingdom

Email	mark.piper@nhct.nhs.uk

Study information

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
Study setting(s)	Hospital
Study type	Quality of life
Participant information sheet	https://docs.google.com/viewer?a=v&pid=sites&srcid=ZGVmYXVsdGRvbWFpbnxzcHdjdHJpYWx8Z3g6YzU3NjZlNDMwZDU1YTlj
Scientific title	Additional pain control using Surgically Placed Wound Catheters (SPWC) and local anaesthetic infusion after mastectomy and breast reconstruction a randomized controlled trial
Study acronym	SPWC
Study objectives	Usage of surgically placed wound catheter and local anaesthetic infusion will improve pain relief and comfort after breast surgery
Ethics approval(s)	Newcastle 2 Ethics committee ref: 11/NE/0131
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	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 study start date	01/09/2011
Completion date	31/08/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	100
Key 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
Key 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
Date of first enrolment	01/09/2011
Date of final enrolment	31/08/2012

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Wansbeck General Hospital

Ashington
NE63 9JJ
United Kingdom

Sponsor information

Northumbria Healthcare NHS Foundation Trust (UK)
Hospital/treatment centre

Rake Lane
North Shields
NE27 0BF
England
United Kingdom

Phone	+44 (0)844 811 8111
Email	caroline.potts@NHCT.nhs.uk
Website	http://www.northumbria.nhs.uk/
"ROR"	https://ror.org/01gfeyd95

Funders

Funder type

Hospital/treatment centre

Northumbria Healthcare NHS Foundation Trust - Breast Cancer Care Fund (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

11/05/2018: No publications found, verifying study status with principal investigator
01/03/2016: No publications found, verifying study status with principal investigator