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Ultrasound-guided Ilioinguinal-iliohypogastric Block for Inguinal Hernia Repair

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2010 by Bispebjerg Hospital.
Recruitment status was:  Recruiting
Information provided by:
Bispebjerg Hospital Identifier:
First received: March 28, 2011
Last updated: March 29, 2011
Last verified: April 2010
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
Intervention Model: Parallel Assignment
Masking: Double Blind (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?

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 ]

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

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

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

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


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

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
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Please refer to this study by its identifier: NCT01326039

Copenhagen University Hospital Bispebjerg Recruiting
Copenhagen, NV, Denmark, 2400
Contact: Finn Bærentzen, MD    35313531   
Contact: Kenneth Jensen, MD    35313531 ext 4496   
Principal Investigator: Finn Bærentzen, MD         
Sub-Investigator: Jens Børglum, MD         
Sub-Investigator: Kenneth Jensen, MD         
Sponsors and Collaborators
Bispebjerg Hospital
Study Chair: Kenneth Jensen, MD Copenhagen University Hospital Bispebjerg, Denmark
  More Information

Responsible Party: Finn Bærentzen, MD, Copenhagen University Hospital Bispebjerg Identifier: NCT01326039     History of Changes
Other Study ID Numbers: BBH_2010_IIH
Study First Received: March 28, 2011
Last Updated: March 29, 2011

Additional relevant MeSH terms:
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents processed this record on April 26, 2017