Condition category
Signs and Symptoms
Date applied
16/06/2008
Date assigned
18/07/2008
Last edited
06/05/2016
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 Chetan Patel

ORCID ID

Contact details

Queen Victoria Hospital
Holtye Road
E Grinstead
RH19 3DZ
United Kingdom
+44 (0)1342 414000
chetan.patel@qvh.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RPC178

Study information

Scientific title

The effect of Intra-operative Passive Movement on Non-Surgical Site Pain after breast reconstructive surgery

Acronym

IPM for NSSP

Study hypothesis

There is no statistically significant reduction in the pain experienced by patients undergoing breast reconstructive surgery who receive intra-operative passive movement (IPM) therapy.

Ethics approval

Brighton West Research Ethics Committee, 24/01/2008, ref: 07/H111/93

Study design

Prospective double-blinded randomised controlled trial

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

Non-surgical site pain

Intervention

Intra-operative passive movements (IPM):
The treatment protocol was devised by the hospital's senior physiotherapists using techniques described by Maitland. The movements have been standardised (each movement is to be performed twice) and will take five minutes. The treatment will be administered once during a natural break in surgery and again at the end of surgery before the patients are taken through to the recovery ward. IPM will not interfere with the surgeon and will be well away from where the surgeon is working. Sterility of the surgical field will be ensured at all times. Trained anaesthetic assistants who are responsible for patient positioning along with the anaesthetists and surgeons will carry out the treatment. The anaesthetic assistants will be trained by a named researcher, using a DVD designed specially for this IPM therapy.

Control:
Control treatment is passive movements of both upper limbs and lower limbs, and is carried out in sequence over a period of 5 minutes.

The first treatment is during a natural break (mid-surgery), and the second is after completion of surgery. The total duration of the treatment is 10 minutes, and follow up will be 24 hours.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The mean Visual Analogue Scale (VAS) pain score at 1 hour post-operatively.

Secondary outcome measures

The mean cumulative morphine consumption in 24 hours post-operatively.

Overall trial start date

01/05/2008

Overall trial end date

01/11/2009

Reason abandoned

Eligibility

Participant inclusion criteria

Women over the age of 18 years undergoing delayed deep inferior epigastric perforators (DIEP) and trans-rectus abdominis muscle (TRAM) breast reconstructive surgery.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

42

Participant exclusion criteria

1. Patients who are unable to give full consent or do not wish to take part in the trial
2. Chronic pain patients requiring medication for their condition
3. Patients with allergies or contra-indications to the analgesics or anaesthetic drugs stated in the protocol

Recruitment start date

01/05/2008

Recruitment end date

01/11/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Queen Victoria Hospital
Holtye Road
E Grinstead
RH19 3DZ
United Kingdom

Sponsor information

Organisation

Queen Victoria Hospital NHS Foundation Trust (UK)

Sponsor details

Holtye Road
East Grinstead
RH19 3DZ
United Kingdom
+44 (0)1342 414573
sarah.dawe@qvh.nhs.uk

Sponsor type

Government

Website

http://www.qvh.nhs.uk/

Funders

Funder type

Government

Funder name

Queen Victoria Hospital NHS Foundation Trust (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

06/05/2016: No publications found, verifying study status with principal investigator.