Continuous TAP blocks for major gynaecological surgery
| ISRCTN | ISRCTN60295543 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN60295543 |
| Secondary identifying numbers | 16HH3332 |
- 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
Contact information
Dr Geoffrey Lockwood
Scientific
Scientific
Department of Anaesthesia
Hammersmith Hospital
Ducane Road
London
W12 0HS
United Kingdom
 ORCID ID |
0000-0003-3180-5824 |
|---|
Study information
| Study design | Single-centre, double blind, randomized, controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | |
| 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 study start date | 02/04/2014 |
| Completion date | 01/11/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
Hammersmith Hospital
Ducane Road
London
W12 0HS
United Kingdom
London
W12 0HS
United Kingdom
Sponsor information
Joint Research Governance Office, Imperial College Healthcare Trust
Hospital/treatment centre
Hospital/treatment centre
St Mary's Hospital, Praed Street
London
W2 1PG
England
United Kingdom
| Website | www.ic.ac.uk/clinicalresearchgovernanceoffice |
|---|---|
"ROR" |
https://ror.org/056ffv270 |
Funders
Funder type
Hospital/treatment centre
Imperial College Healthcare Trust, Department of Anaesthetics and Critical Care
No information available
Results and Publications
| Intention to publish date | 31/07/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Results will be published in a peer-reviewed journal. |
| 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? |
|---|---|---|---|---|---|
| Participant information sheet | 23/06/2016 | 24/06/2016 | No | Yes | |
| HRA research summary | 28/06/2023 | No | No |
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.
