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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01793571
Recruitment Status : Unknown
Verified February 2013 by Peter Dijkhuizen, Dijklander Ziekenhuis.
Recruitment status was:  Active, not recruiting
First Posted : February 15, 2013
Last Update Posted : February 15, 2013
Sponsor:
Information provided by (Responsible Party):
Peter Dijkhuizen, Dijklander Ziekenhuis

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.

Condition or disease Intervention/treatment Phase
Hernia Inguinal Procedure: TAP block Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Pilot Study on the Effectiveness of the Echoguided Transversus Abdominis Plane Block During Inguinal Hernia Repair Surgery
Study Start Date : September 2012
Estimated Primary Completion Date : March 2013
Estimated Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

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)




Primary Outcome Measures :
  1. 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 Measures :
  1. time to to first use of intravenous morfine [ Time Frame: 48 hours ]
  2. the total amount of titrated postoperative morfine [ Time Frame: 48 hours ]
  3. use of tramadol at home [ Time Frame: 48 hours ]
  4. patient satisfaction [ Time Frame: 48 hours ]
  5. the incidence of nausea and vomiting [ Time Frame: 48 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01793571


Locations
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Netherlands
Westfriesgasthuis
Hoorn, Noord-Holland, Netherlands, 1620AR
Sponsors and Collaborators
Dijklander Ziekenhuis
Investigators
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Principal Investigator: Jens P Hering, Anesthesiologist Dijklander Ziekenhuis

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Responsible Party: Peter Dijkhuizen, MPA Anesthesiology, Dijklander Ziekenhuis
ClinicalTrials.gov Identifier: NCT01793571    
Other Study ID Numbers: NL40460.094.12
First Posted: February 15, 2013    Key Record Dates
Last Update Posted: February 15, 2013
Last Verified: February 2013
Keywords provided by Peter Dijkhuizen, Dijklander Ziekenhuis:
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
Additional relevant MeSH terms:
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Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal
Levobupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents