Does placement of a TAP block in patients undergoing laparoscopic inguinal hernia repair have a more efficacious analgesic effect than local infiltration at the surgical site: a randomized controlled trial.

2024-515759-39-00 Therapeutic use (Phase IV) Ongoing, recruiting

Start 13 May 2025 · Status Ongoing, recruiting · 1 EU/EEA countries · 2 sites

Overview

Sponsor-declared trial summary

Phase Therapeutic use (Phase IV)
Status Ongoing, recruiting
Participants planned 80
Countries 1
Sites 2

inguinal hernia

The primary objective of this study is to evaluate whether the use of a locoregional technique, ei-ther TAP block or port site wound infiltration, provides superior analgesic efficacy in postopera-tive pain management.

Key facts

Sponsor
Universitair Ziekenhuis Brussel
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Analytical,Diagnostic,Therapeutic Techniques and Equipment [E]-Surgical Procedures, Operative [E04], Diseases [C] - Digestive System Diseases [C06]
Trial duration
13 May 2025 → ongoing
Decision date (initial)
2024-11-21
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: Efficacy

The primary objective of this study is to evaluate whether the use of a locoregional technique, ei-ther TAP block or port site wound infiltration, provides superior analgesic efficacy in postopera-tive pain management.

Secondary objectives 1

  1. The secondary objective of this study is to determine if there is a difference in reduced intake of analgesics postoperatively between the two groups

Conditions and MedDRA coding

inguinal hernia

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

  1. ASA I to III patients
  2. Patients between 18 and 80 years old
  3. Patients undergoing a laparoscopic inguinal hernia repair operation.

Exclusion criteria 11

  1. Patients with a BMI > 35 kg/m2
  2. Patients who are pregnant
  3. Patients labeled with ASA IV
  4. Patients who have demonstrated hypersensitivity/allergic reaction to “other local anesthetic of the amide type”
  5. Patients known with a chronic pain syndrome
  6. Patients known with a polyneuropathy
  7. Patients taking daily opioids
  8. Patients younger than 18 years old and older than 80 years old
  9. Patients who did not give their consent for participation in the study
  10. Redo operations
  11. Patients with hemodynamic instability, such as “hypovolemia”

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. The primary endpoint was the Numeric Rating Scale (NRS) pain score assessed at multiple post-operative time points.

Secondary endpoints 1

  1. The secondary objective is to compare the amount of dipidolor, expressed in milligrams, given in the PACU and the amount of analgesics used at home

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Ropivacaine Fresenius Kabi 7,5 mg/1 ml Solution injectable

PRD767241 · Product

Active substance
Ropivacaine Hydrochloride
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INJECTION
Max daily dose
113 mg milligram(s)
Max total dose
800 mg milligram(s)
Max treatment duration
3 Day(s)
Authorisation status
Authorised
ATC code
N01BB09 — ROPIVACAINE
Marketing authorisation
2010120043
MA holder
FRESENIUS KABI NV/SA
MA country
Luxembourg
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Placebo 1

NaCl 0,9 % B. Braun, oplossing voor injectie

PRD9621455 · Product

Active substance
Sodium Chloride
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INJECTION
Max daily dose
40 ml millilitre(s)
Max total dose
40 ml millilitre(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
V07AB — SOLVENTS AND DILUTING AGENTS, INCL. IRRIGATING SOLUTIONS
Marketing authorisation
BE128125
MA holder
B.BRAUN MELSUNGEN AG
MA country
Belgium
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Universitair Ziekenhuis Brussel

3 Total trials 2 Recruiting 1 Ended
Academic / Non-commercial
Sponsor organisation
Universitair Ziekenhuis Brussel
Address
Laarbeeklaan 101
City
Jette
Postcode
1090
Country
Belgium

Scientific contact point

Organisation
Universitair Ziekenhuis Brussel
Contact name
Vanhonacker Domien

Public contact point

Organisation
Universitair Ziekenhuis Brussel
Contact name
Vanhonacker Domien

Locations

1 EU/EEA country · 2 investigational sites

By country

CountryMS statusPlanned subjectsSites
Belgium Ongoing, recruiting 80 2
Rest of world — 0 —

Investigational sites

Belgium

2 sites · Ongoing, recruiting
AZ Rivierenland
Anesthesiology, 'S Herenbaan 172, 2840, Rumst
UZ Brussel
Anesthesiology, Laarbeeklaan 101, 1090, Jette

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Belgium 2025-05-13 2025-07-24

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 17 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D1_protocol_2024-515759-39-00_redacted 5.0
Protocol (for publication) D1_Protocol_2024-515759-39-00_tracked 5.0
Protocol (for publication) D4_Patient facing documents_FR_Pain diary_redacted 4.0
Protocol (for publication) D4_patient facing documents_FR_pain diary_TC 4.0
Protocol (for publication) D4_Patient facing documents_NL_Pain diary_redacted 4.0
Protocol (for publication) D4_patient facing documents_NL_pain diary_TC 4.0
Recruitment arrangements (for publication) K1_Recruitment arrangements 1
Subject information and informed consent form (for publication) L1_SIS AND ICF_TAP BLOCK_ICF_FR_redacted 2.0
Subject information and informed consent form (for publication) L1_SIS AND ICF_TAP BLOCK_ICF_FR_tracked 2.0
Subject information and informed consent form (for publication) L1_SIS AND ICF_TAP BLOCK_ICF_NL_redacted 2.0
Subject information and informed consent form (for publication) L1_SIS AND ICF_TAP BLOCK_ICF_NL_tracked 2.0
Synopsis of the protocol (for publication) D1_Protocol synopsis DE_2024-515759-39-00_tracked 4.0
Synopsis of the protocol (for publication) D1_Protocol synopsis FR_2024-515759-39-00_redacted 4.0
Synopsis of the protocol (for publication) D1_Protocol synopsis FR_2024-515759-39-00_tracked 4.0
Synopsis of the protocol (for publication) D1_Protocol synopsis NL__2024-515759-39-00_redacted 4.0
Synopsis of the protocol (for publication) D1_Protocol synopsis NL_2024-515759-39-00_tracked 4.0
Synopsis of the protocol (for publication) D1_Protocol synopsis-DE_2024-515759-39-00_redacted 4.0

Application history

3 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-08-30 Belgium Acceptable with conditions
2024-11-21
 2024-11-21
2 SUBSTANTIAL MODIFICATION SM-1 2025-01-07 Belgium Acceptable
2025-03-17
 2025-03-17
3 SUBSTANTIAL MODIFICATION SM-2 2025-09-24 Belgium Acceptable
2025-10-30
 2025-10-30

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