Ultrasound-guided Ilioinguinal-iliohypogastric Block for Inguinal Hernia Repair

Inguinal Hernia Clinical Trial

Official title:

Does Ultrasound-guided Ilioinguinal-iliohypogastric Block Improve Postoperative Pain Outcome After Unilateral Inguinal Hernia Repair?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01326039
• Other study ID #: BBH_2010_IIH
• Status: Recruiting
• Phase: Phase 4
• First received: March 28, 2011
• Last updated: March 29, 2011
• Start date: May 2010
• Est. completion date: July 2011

Study information

• Verified date: April 2010
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Associate Professor, Poul Lunau Christensen, Copenhagen University Hospital Bispebjerg, Bispebjerg Bakke 23, 2400 NV, Denmark :
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 19 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Inguinal Hernia

Intervention

Drug:
• bupivacaine
perineural bupivacaine 5 mg/ml 20 ml
• saline
perineural isotonic saline 20 ml

Locations

Country	Name	City	State
Denmark	Copenhagen University Hospital Bispebjerg	Copenhagen	NV

Sponsors (1)

Lead Sponsor	Collaborator
Bispebjerg Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain at mobilization using 100 mm VAS		within the first 24 hours postoperatively	No
Secondary	pain at rest using 100 mm VAS		within 24 hours postoperatively	No
Secondary	perceived illness	using short form-8 index	within 24 hours postoperatively	No
Secondary	ability of daily living	using the Barthel/100 index	within 24 hours	No
Secondary	amount of analgesics		within 24 hours postoperatively	No