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
Protocol serial number	N/A
Sponsor	Northumbria Healthcare NHS Foundation Trust (UK)
Funder	Northumbria Healthcare NHS Foundation Trust - Breast Cancer Care Fund (UK)

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

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

Primary study design	Interventional
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
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Opioids
Primary outcome measure(s)	1. Pain scores (daily and average) following the procedure 2. Total opioid requirements 3. Days opioid free
Key secondary outcome measure(s)	Side effects of opioid based analgesics such as nausea, drowsiness and constipation
Completion date	31/08/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	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

United Kingdom
England

Study participating centre

Wansbeck General Hospital

Ashington
NE63 9JJ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

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