Condition category
Cancer
Date applied
06/07/2011
Date assigned
25/08/2011
Last edited
01/03/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

https://docs.google.com/viewer?a=v&pid=sites&srcid=ZGVmYXVsdGRvbWFpbnxzcHdjdHJpYWx8Z3g6YzU3NjZlNDMwZDU1YTlj

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 measures

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

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

http://www.northumbria.nhs.uk/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

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