Condition category
Cancer
Date applied
14/06/2016
Date assigned
23/06/2016
Last edited
24/11/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Lay summary under review with external organisation

Trial website

Contact information

Type

Scientific

Primary contact

Dr Geoffrey Lockwood

ORCID ID

http://orcid.org/0000-0003-3180-5824

Contact details

Department of Anaesthesia
Hammersmith Hospital
Ducane Road
London
W12 0HS
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Version 1

Study information

Scientific title

A double blind, randomized, controlled study to assess the efficacy of continuous transversus abdominis plane (TAP) blocks for analgesia and enhanced recovery following major gynaecological surgery

Acronym

TAPAS

Study hypothesis

Continuous TAP blocks are more effective than the same amount of systemic local anaesthetic

Ethics approval

Not provided at time of registration

Study design

Single-centre, double blind, randomized, controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

See additional files

Condition

Pain after major gynaecological oncology surgery

Intervention

This is a single centre randomised controlled study investigating the effects of bilateral transversus abdominis blockade on post-operative analgesic requirement after major gynaecological surgery. It is impossible to blind all of the clinical team (someone has to know whether they have performed a TAP block) but unblinded staff will not meet the patient post-operatively.

Participants are randomly allocated to one of two groups. Those in group 1 (control group) are given a subcutaneous infusion of local anaesthetic. Additional post-operative analgesia using paracetamol and patient controlled morphine. Those in group 2 (treatment) are given a TAP infusion of local anaesthetic. Additional post-operative analgesia using paracetamol and patient controlled morphine.

While in hospital, the participant is asked a few questions about pain, nausea, vomiting and bowel action each day. On day 3, there are asked to attend a 40 question interview. They are also requested to blow into a machine to measure PEFR daily from the second to the fourth post-operative day (unless discharged earlier). On two days an additional 10ml blood will be drawn to measure lidocaine concentration. These will be drawn at the same time as routine samples.

Intervention type

Drug

Phase

Not Applicable

Drug names

Primary outcome measures

Morphine use via a PCA pump. The amount used will be recorded daily but the primary outcome will be the amount used up to 0800hr on Day 3 (after which the lidocaine infusion will be stopped)

Secondary outcome measures

1. Pain score: Patients will be asked for their pain score (none, mild, moderate or severe) every morning at rest, on taking a deep breath, and on coughing
2. Morphine side effects: Episodes of nausea and vomiting over the last 24 hours will be recorded daily. The day of the first post-operative bowel action will be noted
3. Respiratory function: Peak expiratory flow rate will be recorded pre-operatively and daily from post-operative day 1
4. Operative and clinical outcomes data, including the extent of the abdominal incisions and the duration of hospital stay
5. Adverse events will also be recorded

Overall trial start date

02/04/2014

Overall trial end date

10/01/2019

Reason abandoned

Eligibility

Participant inclusion criteria

Patients aged 30-75 undergoing elective gynaecological oncology surgery

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

62

Participant exclusion criteria

1. Patients unable to give informed consent (mainly language difficulty)
2. Patients with contraindications to drugs specified in the protocol or participation in another medical trial involving medications

Recruitment start date

11/08/2016

Recruitment end date

10/08/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Hammersmith Hospital
Ducane Road
London
W12 0HS
United Kingdom

Sponsor information

Organisation

Joint Research Governance Office, Imperial College Healthcare Trust

Sponsor details

St Mary's Hospital
Praed Street
London
W2 1PG
United Kingdom

Sponsor type

Hospital/treatment centre

Website

www.ic.ac.uk/clinicalresearchgovernanceoffice

Funders

Funder type

Hospital/treatment centre

Funder name

Imperial College Healthcare Trust, Department of Anaesthetics and Critical Care

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Results will be published in a peer-reviewed journal.

Intention to publish date

31/08/2019

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

24/11/2016: Internal review 24/06/2016: Participant information sheet uploaded.