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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01969006
Other study ID # ILIOINGUINAL01
Secondary ID
Status Withdrawn
Phase Phase 2
First received October 21, 2013
Last updated December 16, 2014
Start date January 2014

Study information

Verified date October 2013
Source Randers Regional Hospital
Contact n/a
Is FDA regulated No
Health authority The Regional Committee on Biomedical Research Ethics: Denmark
Study type Interventional

Clinical Trial Summary

This study is undertaken to clarify whether intraoperative blockage with 40 ml of ½ % Marcaine© of the nerves in the ilio-inguinal canal may decrease postoperative pain after laparoscopic inguinal hernia repair.

Patients will be randomised to injection of Marcaine© og a needle prick per-operatively.

Pain will be estimated using the VAS score in:

1. the wound 2 the abdomen 3 the shoulder

Scoring will be performed:

1. pre-operatively

2. 1 hour postoperatively

3. at discharge from the hospital d day 1,2 and 3 post OP

e. 1 year post OP


Description:

as above


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date January 2015
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Age = 18 year

2. Informed consent

3. a diagnosis of an inguinal hernia

4. ASA group = 3

5. BMI = 35

Exclusion Criteria:

1. Communication problems

2. No consent

3. Open procedure (not laparoscopic)

4. ASA-group 4

5. Use of Steroid or immunosuppressive tretament

6. Regular morphine use.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Drug:
Marcaine ½%

Procedure:
Needle prick


Locations

Country Name City State
Denmark Horsens Regions Hospital Horsens
Denmark Randers regions Hospital Randers

Sponsors (3)

Lead Sponsor Collaborator
Randers Regional Hospital Denmark, Regionshospitalet Horsens

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Post operative pain VAS score of pain from:
wound
abdomen
shoulder
1 year No