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
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