The Efficacy of Transversus Abdominis Plane Block After Groin Hernia Repair

Glostrup University Hospital, Copenhagen

Status and phase: Completed; Phase 4

Conditions: Hernia

Treatments: Procedure: Saline; Procedure: Transversus abdominis plane block; Procedure: Local infiltration

Study type: Interventional

Funder types: Other

Identifiers

NCT01052285

SM1-plp-10

2010-018403-29 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to determine whether Transversus abdominis plane block is superior to placebo or superior to local infiltration in analgesic efficacy after groin hernia repair.

Enrollment: 90 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18-75 years old
• groin hernia repair
• written consent
• ASA 1-3
• BMI 18-35

Exclusion criteria

• unable to communicate in Danish
• relevant drug allergy
• pain medication in the last 24 hours
• pregnancy
• alcohol or/and drug abuse
• daily opioid intake
• infection at injection site

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

90 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

TAP block with 25 ml of saline Ilioinguinal block with 10 ml of saline and local infiltration with 40 ml of saline.

Treatment:

Procedure: Saline

Local infiltration

Active Comparator group

Description:

Ilioinguinal block with 10 ml of ropivacaine 0,375% Local infiltration with 40 ml of ropivacaine 0,375% Tap block with 25 ml of saline

Treatment:

Procedure: Local infiltration

Transversus abdominis plane block

Experimental group

Description:

25 ml of Ropivacaine 0,75%, Ilioinguinal block with 10 ml saline and local infiltration with 40 ml of saline.

Treatment:

Procedure: Transversus abdominis plane block