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
Protocol serial number	08031RM-T
Sponsor	Belfast Health and Social Care Trust (UK)
Funder	Belfast Health and Social Care Trust (UK) (ref: 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

Department of Anaesthetics & Intensive Care Medicine
Queen's University Belfast
2nd Floor Mulhouse Building
Grosvenor Road
Belfast
BT12 6BJ
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised controlled double blind trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	The reduction in visual analogue scores (VAS) in the post-operative period for patients undergoing total abdominal hysterectomy.
Key secondary outcome measure(s)	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
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 sample size at registration	40
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

United Kingdom
Northern Ireland

Study participating centre

Department of Anaesthetics & Intensive Care Medicine

Belfast
BT12 6BJ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes