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

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.

Study Overview

• Status: Unknown
• Conditions: Hernia Inguinal
• Intervention / Treatment: Procedure: TAP block

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Noord-Holland
    • Hoorn, Noord-Holland, Netherlands, 1620AR
      • Westfriesgasthuis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TAP block; 20 ml Levobupivacaine 0,5%	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)
Active Comparator: Local wound infiltration; 20 ml levobupivacaine 0,5%	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)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Dijklander Ziekenhuis
• Investigators: Principal Investigator: Jens P Hering, Anesthesiologist, Dijklander Ziekenhuis

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Anticipated): March 1, 2013
• Study Completion (Anticipated): March 1, 2013

Study Registration Dates

• First Submitted: January 17, 2013
• First Submitted That Met QC Criteria: February 14, 2013
• First Posted (Estimate): February 15, 2013

Study Record Updates

• Last Update Posted (Estimate): February 15, 2013
• Last Update Submitted That Met QC Criteria: February 14, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: Humans; Adult; Abdominal Muscles/Ultrasonography; Ambulatory Surgical Procedures; Anesthetics, Local/Administration & Dosage; Levobupivacaine/Administration & Dosage; Levobupivacaine/Analogs & Derivatives; Hernia, Inguinal/Surgery; Nerve Block/Methods; Pain Measurement/Methods; Pain, Postoperative/Prevention & Control; Ultrasonography, Interventional
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal
• Other Study ID Numbers: NL40460.094.12

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No