Continuous TAP blocks for major gynaecological surgery

Plain English Summary

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-at-pain-control-after-surgery-for-a-gynaecological-cancer-tapas

Trial website

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

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

16HH3332

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

London-Dulwich NREC, 05/08/2016, ref: 16/LO/1250

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 measure

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

01/11/2019

Reason abandoned (if study stopped)

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

Total final enrolment

19

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

01/11/2019

Countries of recruitment

United Kingdom

Trial participating centre

Hammersmith Hospital
Ducane Road
London
W12 0HS
United Kingdom

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

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

Publication and dissemination plan

Results will be published in a peer-reviewed journal.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Geoff Lockwood at g.lockwood@imperial.ac.uk

Intention to publish date

31/07/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

• ISRCTN60295543_PIS_23Jun16.pdf Uploaded 24/06/2016

09/01/2020: The following changes have been made: 1. The intention to publish date has been changed from 31/08/2019 to 31/07/2020. 2. The total final enrolment number has been added. 08/01/2020: The following changes have been made: 1. The recruitment end date has been changed from 10/08/2018 to 01/11/2019. 2. The overall trial end date has been changed from 10/01/2019 to 01/11/2019. 31/08/2017: Ethics approval has been added. Individual participant sharing statement has been added. 20/02/2017: A link to the Cancer Help UK lay summary has been added to the plain English summary field. 24/06/2016: Participant information sheet uploaded.