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Ultrasound-guided Ilioinguinal-iliohypogastric Block for Inguinal Hernia Repair

Primary Purpose

Inguinal Hernia

Status
Unknown status
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
bupivacaine
saline
Sponsored by
Bispebjerg Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inguinal Hernia

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Copenhagen University Hospital BispebjergRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

bupivacaine

saline

Arm Description

perineural bupivacaine 5 mg/ml 20 ml

perineural isotonic saline 20 ml

Outcomes

Primary Outcome Measures

pain at mobilization using 100 mm VAS

Secondary Outcome Measures

pain at rest using 100 mm VAS
perceived illness
using short form-8 index
ability of daily living
using the Barthel/100 index
amount of analgesics

Full Information

First Posted
March 28, 2011
Last Updated
March 29, 2011
Sponsor
Bispebjerg Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01326039
Brief Title
Ultrasound-guided Ilioinguinal-iliohypogastric Block for Inguinal Hernia Repair
Official Title
Does Ultrasound-guided Ilioinguinal-iliohypogastric Block Improve Postoperative Pain Outcome After Unilateral Inguinal Hernia Repair?
Study Type
Interventional

2. Study Status

Record Verification Date
April 2010
Overall Recruitment Status
Unknown status
Study Start Date
May 2010 (undefined)
Primary Completion Date
June 2011 (Anticipated)
Study Completion Date
July 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Bispebjerg Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
bupivacaine
Arm Type
Active Comparator
Arm Description
perineural bupivacaine 5 mg/ml 20 ml
Arm Title
saline
Arm Type
Placebo Comparator
Arm Description
perineural isotonic saline 20 ml
Intervention Type
Drug
Intervention Name(s)
bupivacaine
Intervention Description
perineural bupivacaine 5 mg/ml 20 ml
Intervention Type
Drug
Intervention Name(s)
saline
Intervention Description
perineural isotonic saline 20 ml
Primary Outcome Measure Information:
Title
pain at mobilization using 100 mm VAS
Time Frame
within the first 24 hours postoperatively
Secondary Outcome Measure Information:
Title
pain at rest using 100 mm VAS
Time Frame
within 24 hours postoperatively
Title
perceived illness
Description
using short form-8 index
Time Frame
within 24 hours postoperatively
Title
ability of daily living
Description
using the Barthel/100 index
Time Frame
within 24 hours
Title
amount of analgesics
Time Frame
within 24 hours postoperatively

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth Jensen, MD
Organizational Affiliation
Copenhagen University Hospital Bispebjerg, Denmark
Official's Role
Study Chair
Facility Information:
Facility Name
Copenhagen University Hospital Bispebjerg
City
Copenhagen
State/Province
NV
ZIP/Postal Code
2400
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Finn Bærentzen, MD
Phone
35313531
Email
finn-baerentzen@tdcadsl.dk
First Name & Middle Initial & Last Name & Degree
Kenneth Jensen, MD
Phone
35313531
Ext
4496
Email
kjen0067@bbh.regionh.dk
First Name & Middle Initial & Last Name & Degree
Finn Bærentzen, MD
First Name & Middle Initial & Last Name & Degree
Jens Børglum, MD
First Name & Middle Initial & Last Name & Degree
Kenneth Jensen, MD

12. IPD Sharing Statement

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Ultrasound-guided Ilioinguinal-iliohypogastric Block for Inguinal Hernia Repair

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