Ultrasound-guided Ilioinguinal-iliohypogastric Block for Inguinal Hernia Repair

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Bispebjerg Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Bispebjerg Hospital
ClinicalTrials.gov Identifier:
NCT01326039
First received: March 28, 2011
Last updated: March 29, 2011
Last verified: April 2010
  Purpose

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 Intervention Phase
Inguinal Hernia
Drug: bupivacaine
Drug: saline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Does Ultrasound-guided Ilioinguinal-iliohypogastric Block Improve Postoperative Pain Outcome After Unilateral Inguinal Hernia Repair?

Resource links provided by NLM:


Further study details as provided by Bispebjerg Hospital:

Primary Outcome Measures:
  • pain at mobilization using 100 mm VAS [ Time Frame: within the first 24 hours postoperatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • pain at rest using 100 mm VAS [ Time Frame: within 24 hours postoperatively ] [ Designated as safety issue: No ]
  • perceived illness [ Time Frame: within 24 hours postoperatively ] [ Designated as safety issue: No ]
    using short form-8 index

  • ability of daily living [ Time Frame: within 24 hours ] [ Designated as safety issue: No ]
    using the Barthel/100 index

  • amount of analgesics [ Time Frame: within 24 hours postoperatively ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: May 2010
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Finn Bærentzen, MD, Copenhagen University Hospital Bispebjerg
ClinicalTrials.gov Identifier: NCT01326039     History of Changes
Other Study ID Numbers: BBH_2010_IIH
Study First Received: March 28, 2011
Last Updated: March 29, 2011
Health Authority: Associate Professor, Poul Lunau Christensen, Copenhagen University Hospital Bispebjerg, Bispebjerg Bakke 23, 2400 NV, Denmark :

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

ClinicalTrials.gov processed this record on September 15, 2014