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

June 12, 2016 updated by: Ilaria Farinelli, S. Anna Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Ravenna, Italy
        • Recruiting
        • Osepdale Santa Maria delle Croci
        • Contact:
          • Riccardo Ragazzi
          • Phone Number: +390532236306
          • Email: rgc@unife.it
        • Sub-Investigator:
          • Ilaria Farinelli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Pain evaluation with NRS at 2,6,12,24 hours after cesarean delivery in TAP block group and in the control group.

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

S. Anna Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Anticipated)

September 1, 2016

Study Completion (Anticipated)

September 1, 2016

Study Registration Dates

First Submitted

May 28, 2016

First Submitted That Met QC Criteria

June 12, 2016

First Posted (Estimate)

June 16, 2016

Study Record Updates

Last Update Posted (Estimate)

June 16, 2016

Last Update Submitted That Met QC Criteria

June 12, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • CEIIAV1574

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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