Pilot Study on the Effectiveness of a TAP-block for Inguinal Hernia Repair
A Pilot Study on the Effectiveness of the Echoguided Transversus Abdominis Plane Block During Inguinal Hernia Repair Surgery
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2012
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
January 17, 2013
CompletedFirst Posted
Study publicly available on registry
February 15, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedFebruary 15, 2013
February 1, 2013
6 months
January 17, 2013
February 14, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Primary objective is to analyse, differences in pain scores between the 2 groups until 48 hours after the operation
48 hours
Secondary Outcomes (5)
time to to first use of intravenous morfine
48 hours
the total amount of titrated postoperative morfine
48 hours
use of tramadol at home
48 hours
patient satisfaction
48 hours
the incidence of nausea and vomiting
48 hours
Study Arms (2)
TAP block
EXPERIMENTAL20 ml Levobupivacaine 0,5%
Local wound infiltration
ACTIVE COMPARATOR20 ml levobupivacaine 0,5%
Interventions
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)
Eligibility Criteria
You may qualify if:
- age between 18 and 80 year, competent, elective surgical treatment, Body Mass Index (BMI) between 20-35.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Westfriesgasthuis
Hoorn, North Holland, 1620AR, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jens P Hering, Anesthesiologist
Dijklander Ziekenhuis
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MPA Anesthesiology
Study Record Dates
First Submitted
January 17, 2013
First Posted
February 15, 2013
Study Start
September 1, 2012
Primary Completion
March 1, 2013
Study Completion
March 1, 2013
Last Updated
February 15, 2013
Record last verified: 2013-02