Comparison of the effect on post-operative pain, patient satisfaction and the incidence of chronic pain by the use of either a transversus abdominis plane nerve block or a standard regime with morphine in patients undergoing surgery for total abdominal hysterectomy
| ISRCTN | ISRCTN69387981 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN69387981 |
| Secondary identifying numbers | 08031RM-T |
- Submission date
- 30/09/2009
- Registration date
- 14/10/2009
- Last edited
- 12/06/2014
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Surgery
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
Ms Rosemary Hogg
Scientific
Scientific
Department of Anaesthetics & Intensive Care Medicine
Queen's University Belfast
2nd Floor Mulhouse Building
Grosvenor Road
Belfast
BT12 6BJ
United Kingdom
Study information
| Study design | Randomised controlled double blind 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 | 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 |
| Study objectives | 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(s) | Health and Social Care Research Ethics Committee (HSC REC 2) (Northern Ireland) approved on the 12th August 2008 (ref: 08/NIR02/75) |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/11/2008 |
| Completion date | 01/02/2010 |
| Reason abandoned (if study stopped) | Participant recruitment issue |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 40 participants - 20 randomised to each group |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/11/2008 |
| Date of final enrolment | 01/02/2010 |
Locations
Countries of recruitment
- Northern Ireland
- United Kingdom
Study participating centre
Department of Anaesthetics & Intensive Care Medicine
Belfast
BT12 6BJ
United Kingdom
BT12 6BJ
United Kingdom
Sponsor information
Belfast Health and Social Care Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Grosvenor Road
Belfast
BT12 6BA
Northern Ireland
United Kingdom
| Website | http://www.belfasttrust.hscni.net |
|---|---|
"ROR" |
https://ror.org/02tdmfk69 |
Funders
Funder type
Government
Belfast Health and Social Care Trust (UK) (ref: 08031RM-T)
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 |
