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Ultrasound-guided Ilioinguinal-iliohypogastric Block for Inguinal Hernia Repair

NCT ID: NCT01326039

Last Updated: 2011-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2011-07-31

Brief Summary

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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

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Conditions

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Inguinal Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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bupivacaine

perineural bupivacaine 5 mg/ml 20 ml

Group Type ACTIVE_COMPARATOR

bupivacaine

Intervention Type DRUG

perineural bupivacaine 5 mg/ml 20 ml

saline

perineural isotonic saline 20 ml

Group Type PLACEBO_COMPARATOR

saline

Intervention Type DRUG

perineural isotonic saline 20 ml

Interventions

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bupivacaine

perineural bupivacaine 5 mg/ml 20 ml

Intervention Type DRUG

saline

perineural isotonic saline 20 ml

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Bispebjerg Hospital

OTHER

Sponsor Role lead

Responsible Party

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Copenhagen University Hospital Bispebjerg

Principal Investigators

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Kenneth Jensen, MD

Role: STUDY_CHAIR

Copenhagen University Hospital Bispebjerg, Denmark

Locations

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Copenhagen University Hospital Bispebjerg

Copenhagen, NV, Denmark

Site Status RECRUITING

Countries

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Denmark

Facility Contacts

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Finn Bærentzen, MD

Role: primary

Kenneth Jensen, MD

Role: backup

Other Identifiers

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BBH_2010_IIH

Identifier Type: -

Identifier Source: org_study_id