Evaluating a new surgical method for reducing pain after ventral hernia repair
| ISRCTN | ISRCTN11379598 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11379598 |
| Secondary identifying numbers | UTN is U1111-1314-6764 |
- Submission date
- 17/10/2024
- Registration date
- 21/10/2024
- Last edited
- 21/10/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
Ventral hernia, often linked with a condition called diastasis rectus abdominis, is a common issue in general surgery. The e-TEP technique is a promising method for fixing this problem, but it can cause significant pain after surgery. This study aims to test a new pain relief method and compare it to existing ones to see which works best.
Who can participate?
Adults aged between 18 and 65 years old who have a ventral hernia associated with diastasis rectus abdominis can participate in this study.
What does the study involve?
Participants will undergo surgery using the e-TEP technique to correct their hernia. They will be randomly assigned to one of three pain relief methods: general anesthesia alone, general anesthesia with an ultrasound-guided TAP block, or general anesthesia with a TAP block guided by direct laparoscopic view. Pain levels will be measured at 2, 6, and 24 hours after surgery.
What are the possible benefits and risks of participating?
The potential benefit is finding a more effective way to manage pain after hernia surgery. However, there are risks associated with surgery and anesthesia, including pain, complications, and the usual risks of surgical procedures.
Where is the study run from?
The study is being conducted at Gafrée e Guinle University Hospital (Brazil)
When is the study starting and how long is it expected to run for?
February 2023 to March 2024
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Daniel Mariano de Andrade at danielmarianodeandrade@gmail.com
Contact information
Public, Scientific, Principal Investigator
Mariz e Barros Street, n 775 - Maracanã
Rio de Janeiro
20270-004
Brazil
 ORCID ID |
0009-0007-9779-3404 |
|---|---|
| Phone | +55 (21)98272-8272 |
| daniel.andrade@ebserh.gov.br |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | E-TEP surgery for ventral hernias: a novel and effective approach to postoperative analgesia |
| Study objectives | Compare the effectiveness of direct visualization TAP block to ultra-sound guided TAP block and general anesthesia alone for pain control after ventral hernia and diastasis rectus abdominis correction surgery using laparoscopic e-TEP, as well as their administration times. |
| Ethics approval(s) |
Approved 28/02/2023, Research Ethics Committee of the Gaffréé e Guinle University Hospital (Mariz e Barros Street, n 775 - Maracanã, Rio de Janeiro, 20270-004, Brazil; +55 (21)97246-8917; cep.hugg@unirio.br), ref: Version 2; CAAE: 66449322.4.0000.5258; Project Approval Number: 5.915.842 |
| Health condition(s) or problem(s) studied | Study of the effectiveness provided by Direct Visualization TAP Block analgesia in patients submitted to Diastasis Rectus Abdominis (DRA) associated with Ventral Hernia (VH) correction surgery. |
| Intervention | A total of 30 patients, aged between 18 and 65 years, were selected to undergo surgery to correct Diastasis Rectus Abdominis associated Ventral Hernia using the laparoscopic e-TEP technique. The patients were randomly divided into three groups based on the analgesia protocol: direct visualization TAP Block, ultrasound-guided TAP Block, and general anesthesia alone. The randomization technique used was alternate allocation, ensuring an equal number of patients in each group. The duration of the treatment was the time spent in performing the surgeries (156 - 218 minutes on average per surgery) and Local Anesthetic administration (1 minute and 53 seconds on average), since it was an on time intervention. The follow-up of the 3 arms studied was 1 year in duration. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Postoperative pain was assessed at 2h, 6h and 24h post-surgery, by direct verbal questioning, using the numeric rating scale, from 0 (no pain) to 10 (worst imaginable pain) |
| Secondary outcome measures | Local anesthetic administration time was also ascertained at 2h, 6h and 24h post-surgery, comparing the GA, US-TAPB and DV-TAPB groups |
| Overall study start date | 28/02/2023 |
| Completion date | 17/03/2024 |
Eligibility
| Participant type(s) | Health professional |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 30 |
| Total final enrolment | 30 |
| Key inclusion criteria | Patients, aged between 18 and 65 years old, who presented with Ventral Hernia associated with Diastasis Rectus Abdominis. |
| Key exclusion criteria | 1. Age <18 or >65 years 2. Allergy to local anesthetic 3. History of chronic pain 4. Continuous use of analgesics and corticosteroids 5. Presence of sensory peripheral neuropathies 6. Glycated hemoglobin >6.5% 7. Body mass index (BMI) >40 kg/m² 8. Hernia and/or diastasis >8 cm 9. Surgical risk ASA >II 10. Patients who required Transversus Abdominis Release (TAR) during surgery were also excluded |
| Date of first enrolment | 28/02/2023 |
| Date of final enrolment | 31/10/2023 |
Locations
Countries of recruitment
- Brazil
Study participating centre
Rio de Janeiro
20270-004
Brazil
Sponsor information
Hospital/treatment centre
Mariz e Barros Street, n 775 - Maracanã
Rio de Janeiro
22210-085
Brazil
| Phone | +55 (21)982728272 |
|---|---|
| cep.hugg@unirio.br | |
| Website | https://www.gov.br/ebserh/pt-br/hospitais-universitarios/regiao-sudeste/hugg-unirio |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 15/11/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analyzed during the current study will be available upon request from Daniel Mariano de Andrade (main author) danielmarianodeandrade@gmail.com |
Editorial Notes
21/10/2024: Trial's existence confirmed by Research Ethics Committee of the Gaffréé e Guinle University Hospital.
