Overview
Sponsor-declared trial summary
Chronic postsurgical pain after open inguinal hernia mesh repair
To assess de difference in chronic postsurgical pain incidence between patients who receive the TAP block pre versus post open inguinal hernia mesh repair using the sf-IPQ questionnaire three months after the surgery
Key facts
- Sponsor
- Hospital Central De La Defensa Gomez Ulla
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02], Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 20 Sep 2024 → ongoing
- Decision date (initial)
- 2024-08-12
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Prophylaxis
To assess de difference in chronic postsurgical pain incidence between patients who receive the TAP block pre versus post open inguinal hernia mesh repair using the sf-IPQ questionnaire three months after the surgery
Secondary objectives 3
- To assess the differece in use of analgesic drugs three months after the surgery between patients who receive pre versus post TAP block in open inguinal hernia mesh repair
- To assess the difference in inguinal pain (using the sf-IPQ questionnaire) before and after the surgery in every group
- To assess the difference in the use of analgesic drugs before and after the surgery in every group
Conditions and MedDRA coding
Chronic postsurgical pain after open inguinal hernia mesh repair
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | LLT | 10066568 | Chronic abdominal pain | 10017947 |
| 20.0 | LLT | 10019917 | Hernia inguinal | 10017947 |
| 20.0 | PT | 10022016 | Inguinal hernia | 100000004856 |
| 25.1 | PT | 10087945 | Abdominal wall pain | 100000004856 |
| 21.1 | LLT | 10002321 | Anesthesia | 10029205 |
| 20.0 | PT | 10029173 | Nerve block | 100000004865 |
| 25.1 | LLT | 10087726 | Extraperitoneal mesh implantation | 100000004848 |
| 20.0 | LLT | 10036654 | Prevention | 10042613 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Allocation Allocation of the patients to the groups will be done randomly with the aid of a coin
|
Randomised Controlled | Double | [{"id":59529,"code":4,"name":"Analyst"},{"id":59530,"code":1,"name":"Subject"}] | Group A: Patients receiving the TAP block before the surgery Group B: Patients receiving the TAP block after the surgery |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Patients over 18 years old
- Patients scheduled to undergo open inguinal hernia mesh repair accoding to Lichtenstein technique
- Patients with symptomatic inguinal hernia clinically confirmed or with image test
- Ability to give written informed consent
- Patients with clinical consideration ASA I, II or III
Exclusion criteria 9
- Recurrent hernias or those requiring a different therapeutic technique
- Urgent or complicated surgery or hernia
- Previous chronic inguinal pain
- Severe neuromuscular disorders
- Pregnancy or lactation
- Previous opioid treatment
- Inability to understand the trial's instructions
- Patients participating in other trials at the same time
- Allergy to any of the drugs used
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Prevention of chronic postsurgical pain in patients udergoing open inguinal hernia mesh repair with the use of a TAP block
Secondary endpoints 1
- Decrease in the chronic use of analgesic drugs in patients undergoing open inguinal hernia mesh repair with the use of a TAP block
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
—
SCP15540590 · ATC
- Route of administration
- LOCAL INJECTION
- Max daily dose
- 150 mg milligram(s)
- Max total dose
- 150 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01BB10 — LEVOBUPIVACAINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Hospital Central De La Defensa Gomez Ulla
- Sponsor organisation
- Hospital Central De La Defensa Gomez Ulla
- Address
- Glorieta Del Ejercito S/N
- City
- Madrid
- Postcode
- 28047
- Country
- Spain
Scientific contact point
- Organisation
- Hospital Central De La Defensa Gomez Ulla
- Contact name
- HCD
Public contact point
- Organisation
- Hospital Central De La Defensa Gomez Ulla
- Contact name
- HCD
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 70 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Spain | 2024-09-20 | 2024-09-20 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-13 | Spain | Acceptable 2024-08-12
|
2024-08-12 |