Condition category
Surgery
Date applied
30/09/2009
Date assigned
14/10/2009
Last edited
12/06/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Rosemary Hogg

ORCID ID

Contact details

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

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

http://www.belfasttrust.hscni.net

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

Publication citations

Additional files

Editorial Notes