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

Hernia Inguinal Clinical Trial

Official title:

A Pilot Study on the Effectiveness of the Echoguided Transversus Abdominis Plane Block During Inguinal Hernia Repair Surgery

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01793571
• Other study ID #: NL40460.094.12
• Status: Active, not recruiting
• Phase: N/A
• First received: January 17, 2013
• Last updated: February 14, 2013
• Start date: September 2012
• Est. completion date: March 2013

Study information

• Verified date: February 2013
• Source: Westfriesgasthuis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hernia
• Hernia Inguinal
• Hernia, Inguinal

Intervention

Procedure:
• 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)

Locations

Country	Name	City	State
Netherlands	Westfriesgasthuis	Hoorn	Noord-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Westfriesgasthuis

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary objective is to analyse, differences in pain scores between the 2 groups until 48 hours after the operation		48 hours	No
Secondary	time to to first use of intravenous morfine		48 hours	No
Secondary	the total amount of titrated postoperative morfine		48 hours	No
Secondary	use of tramadol at home		48 hours	No
Secondary	patient satisfaction		48 hours	No
Secondary	the incidence of nausea and vomiting		48 hours	No