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

Primary Purpose

Hernia Inguinal

Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
TAP block
Sponsored by
Dijklander Ziekenhuis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hernia Inguinal focused on measuring Abdominal Muscles/Ultrasonography, Adult, Ambulatory Surgical Procedures, Anesthetics, Local/Administration & Dosage, Levobupivacaine/Administration & Dosage, Levobupivacaine/Analogs & Derivatives, Hernia, Inguinal/Surgery, Humans, Nerve Block/Methods, Pain Measurement/Methods, Pain, Postoperative/Prevention & Control, Ultrasonography, Interventional

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Westfriesgasthuis

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TAP block

Local wound infiltration

Arm Description

20 ml Levobupivacaine 0,5%

20 ml levobupivacaine 0,5%

Outcomes

Primary Outcome Measures

Primary objective is to analyse, differences in pain scores between the 2 groups until 48 hours after the operation

Secondary Outcome Measures

time to to first use of intravenous morfine
the total amount of titrated postoperative morfine
use of tramadol at home
patient satisfaction
the incidence of nausea and vomiting

Full Information

First Posted
January 17, 2013
Last Updated
February 14, 2013
Sponsor
Dijklander Ziekenhuis
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1. Study Identification

Unique Protocol Identification Number
NCT01793571
Brief Title
Pilot Study on the Effectiveness of a TAP-block for Inguinal Hernia Repair
Official Title
A Pilot Study on the Effectiveness of the Echoguided Transversus Abdominis Plane Block During Inguinal Hernia Repair Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Unknown status
Study Start Date
September 2012 (undefined)
Primary Completion Date
March 2013 (Anticipated)
Study Completion Date
March 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dijklander Ziekenhuis

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hernia Inguinal
Keywords
Abdominal Muscles/Ultrasonography, Adult, Ambulatory Surgical Procedures, Anesthetics, Local/Administration & Dosage, Levobupivacaine/Administration & Dosage, Levobupivacaine/Analogs & Derivatives, Hernia, Inguinal/Surgery, Humans, Nerve Block/Methods, Pain Measurement/Methods, Pain, Postoperative/Prevention & Control, Ultrasonography, Interventional

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TAP block
Arm Type
Experimental
Arm Description
20 ml Levobupivacaine 0,5%
Arm Title
Local wound infiltration
Arm Type
Active Comparator
Arm Description
20 ml levobupivacaine 0,5%
Intervention Type
Procedure
Intervention Name(s)
TAP block
Intervention Description
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)
Primary Outcome Measure Information:
Title
Primary objective is to analyse, differences in pain scores between the 2 groups until 48 hours after the operation
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
time to to first use of intravenous morfine
Time Frame
48 hours
Title
the total amount of titrated postoperative morfine
Time Frame
48 hours
Title
use of tramadol at home
Time Frame
48 hours
Title
patient satisfaction
Time Frame
48 hours
Title
the incidence of nausea and vomiting
Time Frame
48 hours

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens P Hering, Anesthesiologist
Organizational Affiliation
Dijklander Ziekenhuis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Westfriesgasthuis
City
Hoorn
State/Province
Noord-Holland
ZIP/Postal Code
1620AR
Country
Netherlands

12. IPD Sharing Statement

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

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