Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
08031RM-T
Study information
Scientific title
Comparison of the effect of transversus abdominis plane block or conventional analgesia on pain scores, patient satisfaction and incidence of chronic pelvic pain after total abdominal hysterectomy: a randomised double-blind controlled trial
Acronym
Study hypothesis
Is there a significant difference in post-operative pain scores in patients undergoing total abdominal hysterectomy who have received bilateral transversus abdominis plane blockade compared to a standard post-operative analgesia regime?
Ethics approval
Health and Social Care Research Ethics Committee (HSC REC 2) (Northern Ireland) approved on the 12th August 2008 (ref: 08/NIR02/75)
Study design
Randomised controlled double blind 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
Total abdominal hysterectomy
Intervention
Patients will be randomised to receive either a bilateral transversus abdominus plane block (TAPB) using 1 mg/kg 0.375% levobupivacaine up to a maximum of 20 ml bilaterally in addition to a standard analgesia regime of patient contolled morphine (1 mg/ml maximum 12 ml/hr) and intravenous paracetamol (1 g 6-hourly). Patients randomised to receive a standard analgesia regime only will have 1 ml of 0.375% levobupivacaine injected into the area where the TAPB would normally be performed in order to maintain the double blind nature of the trial.
Added 09/08/2011: Trial closed early due to low recruitment secondary to change in surgical technique - 30 patients recruited in total.
Intervention type
Procedure/Surgery
Phase
Not Applicable
Drug names
Primary outcome measures
The reduction in visual analogue scores (VAS) in the post-operative period for patients undergoing total abdominal hysterectomy.
Secondary outcome measures
1. Usage of morphine sulphate in the post-operative period
2. Incidence of nausea and/or vomiting within the first 48 hours after surgery
3. Measurement of oxygen saturations without supplemental oxygen in both groups in the post-operative period
4. Incidence of complications associated with the analgesia techniques in both groups
5. Patient satisfaction with analgesia technique
6. Incidence of chronic pelvic pain at 3 months
Overall trial start date
01/11/2008
Overall trial end date
01/02/2010
Reason abandoned
Participant recruitment issue
Eligibility
Participant inclusion criteria
1. American Society of Anaesthesiologists (ASA) class I - III
2. Patients able to give written informed consent
3. Patients requiring total abdominal hysterectomy
4. Female patients aged 18 years and over
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
40 participants - 20 randomised to each group
Participant exclusion criteria
1. Patients requiring total abdominal hysterectomy secondary to neoplasia
2. History of allergy to any of the medications used in the study
3. Pre-operative use of opiates
4. Patients unable to use patient controlled analgesia system
Recruitment start date
01/11/2008
Recruitment end date
01/02/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Anaesthetics & Intensive Care Medicine
Belfast
BT12 6BJ
United Kingdom
Sponsor information
Organisation
Belfast Health and Social Care Trust (UK)
Sponsor details
Grosvenor Road
Belfast
BT12 6BA
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Belfast Health and Social Care Trust (UK) (ref: 08031RM-T)
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