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Ultrasound-guided Ilioinguinal-iliohypogastric Block for Inguinal Hernia Repair

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ClinicalTrials.gov Identifier: NCT01326039
Recruitment Status : Unknown
Verified April 2010 by Bispebjerg Hospital.
Recruitment status was:  Recruiting
First Posted : March 30, 2011
Last Update Posted : March 30, 2011
Sponsor:
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Inguinal Hernia Drug: bupivacaine Drug: saline Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Does Ultrasound-guided Ilioinguinal-iliohypogastric Block Improve Postoperative Pain Outcome After Unilateral Inguinal Hernia Repair?
Study Start Date : May 2010
Estimated Primary Completion Date : June 2011
Estimated Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: bupivacaine
perineural bupivacaine 5 mg/ml 20 ml
Drug: bupivacaine
perineural bupivacaine 5 mg/ml 20 ml
Placebo Comparator: saline
perineural isotonic saline 20 ml
Drug: saline
perineural isotonic saline 20 ml


Outcome Measures

Primary Outcome Measures :
  1. pain at mobilization using 100 mm VAS [ Time Frame: within the first 24 hours postoperatively ]

Secondary Outcome Measures :
  1. pain at rest using 100 mm VAS [ Time Frame: within 24 hours postoperatively ]
  2. perceived illness [ Time Frame: within 24 hours postoperatively ]
    using short form-8 index

  3. ability of daily living [ Time Frame: within 24 hours ]
    using the Barthel/100 index

  4. amount of analgesics [ Time Frame: within 24 hours postoperatively ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01326039


Locations
Denmark
Copenhagen University Hospital Bispebjerg Recruiting
Copenhagen, NV, Denmark, 2400
Contact: Finn Bærentzen, MD    35313531    finn-baerentzen@tdcadsl.dk   
Contact: Kenneth Jensen, MD    35313531 ext 4496    kjen0067@bbh.regionh.dk   
Principal Investigator: Finn Bærentzen, MD         
Sub-Investigator: Jens Børglum, MD         
Sub-Investigator: Kenneth Jensen, MD         
Sponsors and Collaborators
Bispebjerg Hospital
Investigators
Study Chair: Kenneth Jensen, MD Copenhagen University Hospital Bispebjerg, Denmark
More Information

Responsible Party: Finn Bærentzen, MD, Copenhagen University Hospital Bispebjerg
ClinicalTrials.gov Identifier: NCT01326039     History of Changes
Other Study ID Numbers: BBH_2010_IIH
First Posted: March 30, 2011    Key Record Dates
Last Update Posted: March 30, 2011
Last Verified: April 2010

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents