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Tap Block and Cesarean Delivery: Efficacy and Consumption of Postoperative Drugs (TAPFANS)

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: NCT02801968
Recruitment Status : Unknown
Verified May 2016 by Ilaria Farinelli, S. Anna Hospital.
Recruitment status was:  Recruiting
First Posted : June 16, 2016
Last Update Posted : June 16, 2016
Sponsor:
Information provided by (Responsible Party):
Ilaria Farinelli, S. Anna Hospital

Brief Summary:
The purpose of this study is to determine the efficacy of Tap block after cesarean delivery as a component of multimodal analgesia and evaluation of postoperative drugs consumption.

Condition or disease Intervention/treatment Phase
Cesarean Delivery Procedure: Tap block Other: intravenous analgesia Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : April 2016
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arm Intervention/treatment
Experimental: Tap block
Tap block with ropivacaine 2 mg/kg at the end of cesarean delivery. Postoperative analgesia with acetaminophen and tramadol plus NSAIDs (nonsteroidal anti-inflammatory drugs) as rescue dose.
Procedure: Tap block
Other: intravenous analgesia
Active Comparator: control group
Postoperative analgesia after cesarean delivery with acetaminophen and tramadol plus NSAIDs (nonsteroidal anti-inflammatory drugs) as rescue dose.
Other: intravenous analgesia



Primary Outcome Measures :
  1. Pain evaluation with Numerical Rating Scale (NRS) [ Time Frame: Pain evaluation with NRS at 2,6,12,24 hours after cesarean delivery in TAP block group and in the control group. ]
    We don't want to measure the change between each assessment within a single group, instead we want considering the difference in the measurements between two separate groups (TAP block group and control group) for each time point.


Secondary Outcome Measures :
  1. Evaluation of NSAIDs (nonsteroidal anti-inflammatory drugs) consumption as rescue dose during the first 24 hours after cesarean delivery [ Time Frame: Doses of NSAIDs (nonsteroidal anti-inflammatory drugs) administered at 2, 6, 12 ,24 hours after cesarean delivery TAP block group and in the control group. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age > 18 years
  • written consent
  • anesthesiologist's assent on preoperative evaluation

Exclusion Criteria:

  • age< 18 years
  • uncooperative patients
  • written consent not obtained
  • local anesthetic allergy
  • BMI > 35

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): NCT02801968


Contacts
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Contact: Ilaria Farinelli +393332082120 ilaria.farinelli@unife.it

Locations
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Italy
Osepdale Santa Maria delle Croci Recruiting
Ravenna, Italy
Contact: Riccardo Ragazzi    +390532236306    rgc@unife.it   
Sub-Investigator: Ilaria Farinelli         
Sponsors and Collaborators
S. Anna Hospital
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Responsible Party: Ilaria Farinelli, Doctor, S. Anna Hospital
ClinicalTrials.gov Identifier: NCT02801968    
Other Study ID Numbers: CEIIAV1574
First Posted: June 16, 2016    Key Record Dates
Last Update Posted: June 16, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No