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TAP-study


- candidate number23406
- NTR NumberNTR5487
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR18-nov-2015
- Secondary IDsNL49853.094.14 METC number M014-014
- Public TitleTAP-study
- Scientific TitleA randomised, double blind clinical trial comparing the effect of a ultrasound-guided tranversus abdominis plane (TAP) block and wound infiltration on postoperative pain (48h) for open inguinal hernia repair in day care
- ACRONYM
- hypothesisIs a transversus abdominis plane block more effective regarding postoperative pain than perioperative wound infiltration with a long acting local anesthetic for a group of patients for open inguinal hernia repair
- Healt Condition(s) or Problem(s) studiedHernia inguinal
- Inclusion criteriaMale patients, Age between 18-80 years (18-80 jaar), mentally competent, American Society of Anesthesiologists (ASA) class score 1-3, elective surgery, Body Mass Index (BMI) between 20 en 35.
- Exclusion criteriaBody Mass Index (BMI) >35, fever, coagulation disorders ( PT>13 sec en APPT >32 sec), renal insufficiency(eGFR< 50 ml/min), serious hepatic impairment(albumine <30g/L and or INR>2), woundinfection close to punction site, preoperative use of analgetics, hypersensitivity for Levobupivaca´ne
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 11-dec-2014
- planned closingdate30-apr-2016
- Target number of participants60
- InterventionsProcedure/surgery: TAP block 2groups, group A a TAP block with 20ml of levobupivacaine 0,5% and subcutaneous wound infiltration with 20ml sodium chloride (to blind patient and physician) and group B, TAP block with 20ml sodium chloride and subcutaneous wound infiltration with 20ml levobupivacaine 0,5% (to blind patient and physician)
- Primary outcomeAnalyse difference in numeric rating scale between the 2 groups until 48 hours after the operation
- Secondary outcomeTime to first use of intravenous morfine
Total amount of titrated morfine
Use of tramadol at home
Patient satisfaction
The incidence of nausea and vomiting
- TimepointsNRS rating scale 48 hours post surgery
Leiden Perioperative care Patient Satisfaction questionnaire (LPPSq)
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Peter Dijkhuizen
- CONTACT for SCIENTIFIC QUERIES J.P. Hering
- Sponsor/Initiator Westfriesgasthuis Hoorn
- Funding
(Source(s) of Monetary or Material Support)
Westfriesgasthuis Hoorn
- Publications
- Brief summaryHernia inguinal repair is the most common operation performed by general surgeons in the Netherlands. One of the most common complications after hernia repair is postoperative and chronic pain. Postoperative pain is an expected but indesirable effect after an operation, which can result in an prolonged hospital stay or longer time to return to full normal daily activities. Thera are indications that an insufficiant treatment of postoperative pain is a risk factor for persistant or chronic pain after open hernia repair. 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 wil be no further analysis in this study regarding the relation of open hernia repair and chronic pain
- Main changes (audit trail)
- RECORD18-nov-2015 - 7-jan-2016


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