NCT01326039

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2010

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 28, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 30, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

March 30, 2011

Status Verified

April 1, 2010

Enrollment Period

1.1 years

First QC Date

March 28, 2011

Last Update Submit

March 29, 2011

Conditions

Inguinal Hernia

Outcome Measures

Primary Outcomes (1)

  • pain at mobilization using 100 mm VAS

    within the first 24 hours postoperatively

Secondary Outcomes (4)

  • pain at rest using 100 mm VAS

    within 24 hours postoperatively

  • perceived illness

    within 24 hours postoperatively

  • ability of daily living

    within 24 hours

  • amount of analgesics

    within 24 hours postoperatively

Study Arms (2)

bupivacaine

ACTIVE COMPARATOR

perineural bupivacaine 5 mg/ml 20 ml

Drug: bupivacaine

saline

PLACEBO COMPARATOR

perineural isotonic saline 20 ml

Drug: saline

Interventions

bupivacaineDRUG

perineural bupivacaine 5 mg/ml 20 ml

bupivacaine
salineDRUG

perineural isotonic saline 20 ml

saline

Eligibility Criteria

Age19 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age above 18 years
  • unilateral primary inguinal repair
  • open surgery a.m. Lichtenstein
  • informed consent

You may not qualify if:

  • age below 18 years
  • secondary surgery
  • laparoscopic surgery
  • lack of communicative skills

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Copenhagen University Hospital Bispebjerg

Copenhagen, NV, 2400, Denmark

RECRUITING

MeSH Terms

Conditions

Hernia, Inguinal

Interventions

BupivacaineSodium Chloride

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Kenneth Jensen, MD

    Copenhagen University Hospital Bispebjerg, Denmark

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 28, 2011

First Posted

March 30, 2011

Study Start

May 1, 2010

Primary Completion

June 1, 2011

Study Completion

July 1, 2011

Last Updated

March 30, 2011

Record last verified: 2010-04

Locations

DK(1)