Ilioinguinal Block in Laparoscopic Inguinal Hernia Repair

NCT ID: NCT01969006

Last Updated: 2014-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Brief Summary

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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

Detailed Description

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as above

Conditions

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Post Operative Pain as Estimated by the Sue of the VAS Score

Keywords

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inguinal hernia, postoperative pain, localanesthesia, nerve blockage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Injection of Marcaine ½ %

Injection of 40 ml of Marcaine ½ % 2 cm medial, 2 cm downwards from the Anterior Iliac Spine

Group Type EXPERIMENTAL

Marcaine ½%

Intervention Type DRUG

Needle prick

Needle prick 2 cm medial and 2 cm downwards from the Anterior Iliac spine

Group Type PLACEBO_COMPARATOR

Needle prick

Intervention Type PROCEDURE

Interventions

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Marcaine ½%

Intervention Type DRUG

Needle prick

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Regionshospitalet Horsens

OTHER

Sponsor Role collaborator

Denmark

UNKNOWN

Sponsor Role collaborator

Randers Regional Hospital

OTHER

Sponsor Role lead

Responsible Party

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Thorbjorn Sommer

Senior Surgeon phd, ass proffessor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Horsens Regions Hospital

Horsens, , Denmark

Site Status

Randers regions Hospital

Randers, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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ILIOINGUINAL01

Identifier Type: -

Identifier Source: org_study_id