Continuous TAP blocks for major gynaecological surgery

ISRCTN	ISRCTN60295543
DOI	https://doi.org/10.1186/ISRCTN60295543
Protocol serial number	16HH3332
Sponsor	Joint Research Governance Office, Imperial College Healthcare Trust
Funder	Imperial College Healthcare Trust, Department of Anaesthetics and Critical Care

Submission date: 14/06/2016
Registration date: 23/06/2016
Last edited: 24/02/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Contact information

Dr Geoffrey Lockwood
Scientific

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

ORCID ID	0000-0003-3180-5824

Study information

Primary study design	Interventional
Study design	Single-centre, double blind, randomized, controlled study
Secondary study design	Randomised controlled trial
Participant information sheet	ISRCTN60295543_PIS_23Jun16.pdf
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
Study acronym	TAPAS
Study objectives	Continuous TAP blocks are more effective than the same amount of systemic local anaesthetic
Ethics approval(s)	London-Dulwich NREC, 05/08/2016, ref: 16/LO/1250
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)
Primary outcome measure(s)	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)
Key secondary outcome measure(s)	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
Completion date	01/11/2019

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	42
Total final enrolment	19
Key inclusion criteria	Patients aged 30-75 undergoing elective gynaecological oncology surgery
Key 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
Date of first enrolment	11/08/2016
Date of final enrolment	01/11/2019

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Hammersmith Hospital

Ducane Road
London
W12 0HS
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
HRA research summary			28/06/2023	No	No
Participant information sheet		23/06/2016	24/06/2016	No	Yes
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Additional files

ISRCTN60295543_PIS_23Jun16.pdf: Uploaded 24/06/2016

Editorial Notes

24/02/2021: The target number of participants was changed from 62 to 42.
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.