Does massage during a long operation reduce pain in the recovery period?

ISRCTN	ISRCTN04980611
DOI	https://doi.org/10.1186/ISRCTN04980611
Secondary identifying numbers	RPC178

Submission date: 16/06/2008
Registration date: 18/07/2008
Last edited: 22/12/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Signs and Symptoms

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Chetan Patel
Scientific

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

Phone	+44 (0)1342 414000
Email	chetan.patel@qvh.nhs.uk

Study information

Study design	Prospective double-blinded randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	The effect of Intra-operative Passive Movement on Non-Surgical Site Pain after breast reconstructive surgery
Study acronym	IPM for NSSP
Study objectives	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(s)	Brighton West Research Ethics Committee, 24/01/2008, ref: 07/H111/93
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/05/2008
Completion date	01/11/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target number of participants	42
Key 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.
Key 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
Date of first enrolment	01/05/2008
Date of final enrolment	01/11/2009

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Queen Victoria Hospital

Holtye Road
E Grinstead
RH19 3DZ
United Kingdom

Sponsor information

Queen Victoria Hospital NHS Foundation Trust (UK)
Hospital/treatment centre

Holtye Road
East Grinstead
RH19 3DZ
England
United Kingdom

Phone	+44 (0)1342 414573
Email	sarah.dawe@qvh.nhs.uk
Website	http://www.qvh.nhs.uk/
"ROR"	https://ror.org/03bs2yy11

Funders

Funder type

Government

Queen Victoria Hospital NHS Foundation Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

22/12/2020: Internal review.
06/05/2016: No publications found, verifying study status with principal investigator.