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
16HH3332
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
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 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
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.
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
31/08/2019
Participant level data
Available on request
Results - basic reporting
Publication summary
Publication citations
Additional files
- ISRCTN60295543_PIS_23Jun16.pdf Uploaded 24/06/2016