Ilioinguinal Block in Laparoscopic Inguinal Hernia Repair

Phase 2

Withdrawn

• Conditions: Post Operative Pain as Estimated by the Sue of the VAS Score
• Interventions: Drug: Marcaine ½%; Procedure: Needle prick

• Registration Number: NCT01969006
• Lead Sponsor: Randers Regional Hospital

Brief Summary

This study is undertaken to clarify whether intraoperative blockage with 40 ml of ½ % Marcaine© of the nerves in the ilio-inguinal canal may decrease postoperative pain after laparoscopic inguinal hernia repair.

Patients will be randomised to injection of Marcaine© og a needle prick per-operatively.

Pain will be estimated using the VAS score in:

1. the wound 2 the abdomen 3 the shoulder

Scoring will be performed:

1. pre-operatively

2. 1 hour postoperatively

3. at discharge from the hospital d day 1,2 and 3 post OP

e. 1 year post OP

Detailed Description

as above

Study Timeline

• Status Verified: 2013-10
• Study First Submitted: 2013-10-21
• Study First Submitted QC: 2013-10-21
• Study First Posted: 2013-10-24
• Study Start: 2014-01
• Last Update Submitted: 2014-12-16
• Last Update Posted: 2014-12-17
• Primary Completion: 2015-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

1. Age ≥ 18 year
2. Informed consent
3. a diagnosis of an inguinal hernia
4. ASA group ≤ 3
5. BMI ≤ 35

Exclusion Criteria

1. Communication problems
2. No consent
3. Open procedure (not laparoscopic)
4. ASA-group 4
5. Use of Steroid or immunosuppressive tretament
6. Regular morphine use.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Injection of Marcaine ½ %	Marcaine ½%	Injection of 40 ml of Marcaine ½ % 2 cm medial, 2 cm downwards from the Anterior Iliac Spine
Needle prick	Needle prick	Needle prick 2 cm medial and 2 cm downwards from the Anterior Iliac spine

Primary Outcome Measures

Name	Time	Method
Post operative pain	1 year	VAS score of pain from: 1. wound; 2. abdomen; 3. shoulder

Trial Locations

Locations (2)

Horsens Regions Hospital; 🇩🇰 Horsens, Denmark

Randers regions Hospital; 🇩🇰 Randers, Denmark