Condition category
Signs and Symptoms
Date applied
01/11/2007
Date assigned
03/04/2008
Last edited
18/11/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Gail Gillespie

ORCID ID

Contact details

Royal Cornwall Hospital Trust
Treliske
Truro
Cornwall
TR1 3LJ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

SPI-Mas

Study hypothesis

The primary common complications of mastectomy with axillary node clearance are post-operative pain and slow recovery of shoulder function.

Historically, mastectomy patients are managed on the wards with systemic opiates, either by intramuscular injection or using a Patient Controlled Analgesia (PCA) device. Problems commonly associated with this technique are inadequate pain control, post-operative nausea and vomiting, poor recovery of shoulder function and chronic pain.

We ask the question: can post-operative analgesia be improved in this patient group by the use of local anaesthetic infusion via a sub pectoral catheter?

This prospective, randomised double blind placebo-controlled study of patients undergoing mastectomy plus axillary sampling or clearance for breast cancer aims to investigate whether this technique confers any advantages over current practice.

Ethics approval

Ethics approval will be submitted from the Cornwall NHS Hospitals Local Research and Ethics Committee. Pending as of 06/11/2007.

Study design

A prospective, single-centre, double blind randomised placebo-controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Post-mastectomy pain

Intervention

Local anaesthetic bupivacaine infusion (initial bolus of 20 ml of 0.5% sterile bupivacaine) via a sub-pectoral catheter inserted intra-operatively versus saline control (initial bolus of 20 ml sterile saline 0.9%).

Thereafter continuous drug infusion will be 270 ml of either 0.25% bupivacaine or of 0.9% saline via an elastomeric infusion device delivering 5 ml/hr over 48 hours.

All study arms have same duration. Initial phase of study is for the first 10 days following surgery, the second phase is the follow-up at 6 and 12 months. Total duration will therefore be 12 months.

Intervention type

Drug

Phase

Not Specified

Drug names

Bupivacaine

Primary outcome measures

Post-operative analgesia as assessed by:
1. Total morphine requirements at 24 and 48 hours
2. Pain scores at rest on first wakening using a Verbal Rating Scale
3. Pain scores at rest and on movement using a Visual Analogue Scale at 24 and 48 hours
4. Time from end of surgery to first analgesia
5. Subsequent oral analgesia (oromorph) requirements

Secondary outcome measures

1. Pain scores at rest and on movement using a Visual Analogue Scale at 10 days, 6 months and 1 year
2. Shoulder function assessment using Oxford Shoulder Score and Shoulder Goniometry at 24 hours, 48 hours, 10 days and 6 months
3. Incidence and severity of nausea and vomiting
4. Requirement for post-operative anti-emetic
5. Surgical complications, e.g., seroma/infection
6. Patient satisfaction at 10 days
7. Analgesia requirements at 6 months
8. Requirement for re-operation due to complication
9. Duration of post-operative hospital stay

Overall trial start date

01/01/2008

Overall trial end date

01/06/2009

Reason abandoned

Eligibility

Participant inclusion criteria

Female patients over the age of 18 who are scheduled for elective single side mastectomy with axillary surgery at Royal Cornwall Hospital Trust will be recruited.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

70

Participant exclusion criteria

1. Concurrent enrolment in any other study/trial
2. Pregnancy
3. Bilateral surgery
4. Primary reconstructive surgery
5. Known allergy or sensitivity to local anaesthetic agents, morphine, paracetamol or ondansetron
6. Chronic opioid or non-opioid analgesic use
7. Inability to give informed consent
8. Inability to understand or use a patient-controlled analgesia (PCA) device
9. Inability to understand or complete the visual analogue assessment tools

Recruitment start date

01/01/2008

Recruitment end date

01/06/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Cornwall Hospital Trust
Truro, Cornwall
TR1 3LJ
United Kingdom

Sponsor information

Organisation

Royal Cornwall Hospital Trust (UK)

Sponsor details

c/o Cathryn Love-Rouse
Senior Manager Research and Development
Research and Development Directorate
Knowledge Spa
Truro
TR1 3HD
United Kingdom

Sponsor type

Government

Website

http://www.cornwall.nhs.uk/RCHT/Home.aspx

Funders

Funder type

Government

Funder name

Royal Cornwall Hospital Trust (UK) - NHS clinical trial using existing resources

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