Ultrasound-guided Ilioinguinal-iliohypogastric Block for Inguinal Hernia Repair

Phase 4

• Conditions: Inguinal Hernia
• Interventions: Drug: bupivacaine; Drug: saline

• Registration Number: NCT01326039
• Lead Sponsor: Bispebjerg Hospital

Brief Summary

Aim: To investigate whether ultrasound-guided perineural administration of 20 ml bupivacaine 5 mg/ml vs 20 ml isotonic saline at the ilioinguinal-iliohypogastric nerves have a clinically analgesic effect after unilateral open inguinal hernia repair.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-04
• Study Start: 2010-05
• Study First Submitted: 2011-03-28
• Study First Submitted QC: 2011-03-29
• Last Update Submitted: 2011-03-29
• Study First Posted: 2011-03-30
• Last Update Posted: 2011-03-30
• Primary Completion: 2011-06
• Study Completion: 2011-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 60

Inclusion Criteria

• age above 18 years
• unilateral primary inguinal repair
• open surgery a.m. Lichtenstein
• informed consent

Exclusion Criteria

• age below 18 years
• secondary surgery
• laparoscopic surgery
• lack of communicative skills

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
bupivacaine	bupivacaine	perineural bupivacaine 5 mg/ml 20 ml
saline	saline	perineural isotonic saline 20 ml

Primary Outcome Measures

Name	Time	Method
pain at mobilization using 100 mm VAS	within the first 24 hours postoperatively

Secondary Outcome Measures

Name	Time	Method
pain at rest using 100 mm VAS	within 24 hours postoperatively
perceived illness	within 24 hours postoperatively	using short form-8 index
ability of daily living	within 24 hours	using the Barthel/100 index
amount of analgesics	within 24 hours postoperatively

Trial Locations

Locations (1)

Copenhagen University Hospital Bispebjerg; 🇩🇰 Copenhagen, NV, Denmark