Pilot Study on the Effectiveness of a TAP-block for Inguinal Hernia Repair

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2013-03-31

Brief Summary

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An prospective double blinded randomised trial,whether the use of an perioperative echoguided unilateral TAP block has an superior effect on postoperative pain after open hernia inguinal repair compared to wound infiltration with a long acting local anesthetic.

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Detailed Description

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Hernia inguinal repair is the most common operation performed by general surgeons in the Netherlands. On of the most common complications after hernia repair is postoperative and chronic pain. Postoperative pain is an expected but undesirable effect after an operation, which can result in an prolonged hospital stay or longer time to return to full normal daily activities. There are indications that an insufficient treatment of postoperative pain is a risk factor for persistent or chronic pain after open inguinal hernia repair. Chronic pain is not uncommon after hernia repair, with an incidence of 11%.

The objective of this study is to determine, whether the use of an perioperative echo guided unilateral TAP block has an superior effect on postoperative pain after open hernia inguinal repair compared to wound infiltration with a long acting local anesthetic. There will be no further analysis in this study regarding the incidence of open hernia inguinal repair and chronic pain.

Conditions

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Hernia Inguinal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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TAP block

20 ml Levobupivacaine 0,5%

Group Type EXPERIMENTAL

TAP block

Intervention Type PROCEDURE

2 groups, group A a TAP block with 20 ml of Levobupivacaine 0,5% and subcutaneous wound infiltration with 20 ml sodium chloride (to blind patient and physician) and group B, TAP block with 20 ml sodium chloride and subcutaneous wound infiltration with 20 ml Levobupivacaine 0,5% (to blind patient and physician)

Local wound infiltration

20 ml levobupivacaine 0,5%

Group Type ACTIVE_COMPARATOR

TAP block

Intervention Type PROCEDURE

2 groups, group A a TAP block with 20 ml of Levobupivacaine 0,5% and subcutaneous wound infiltration with 20 ml sodium chloride (to blind patient and physician) and group B, TAP block with 20 ml sodium chloride and subcutaneous wound infiltration with 20 ml Levobupivacaine 0,5% (to blind patient and physician)

Interventions

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TAP block

2 groups, group A a TAP block with 20 ml of Levobupivacaine 0,5% and subcutaneous wound infiltration with 20 ml sodium chloride (to blind patient and physician) and group B, TAP block with 20 ml sodium chloride and subcutaneous wound infiltration with 20 ml Levobupivacaine 0,5% (to blind patient and physician)

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* age between 18 and 80 year, competent, elective surgical treatment, Body Mass Index (BMI) between 20-35.

Exclusion Criteria

* fever, a coagulation disorder, patients with kidney and liverfaillure, an infection at the place where the puncture place, preoperative use of narcotic and nonsteroidal antiinflammatory drugs.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes