Tap Block and Cesarean Delivery: Efficacy and Consumption of Postoperative Drugs

Cesarean Delivery Clinical Trial

— TAPFANS  

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02801968
• Other study ID #: CEIIAV1574
• Status: Recruiting
• Phase: N/A
• First received: May 28, 2016
• Last updated: June 12, 2016
• Start date: April 2016
• Est. completion date: September 2016

Study information

• Verified date: May 2016
• Source: S. Anna Hospital
• Contact: Ilaria Farinelli
• Phone: +393332082120
• Email: ilaria.farinelli[@]unife.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 62
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cesarean Delivery

Intervention

Procedure:
• Tap block

Other:
• intravenous analgesia

Locations

Country	Name	City	State
Italy	Osepdale Santa Maria delle Croci	Ravenna

Sponsors (1)

Lead Sponsor	Collaborator
S. Anna Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain evaluation with Numerical Rating Scale (NRS)	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.	Yes
Secondary	Evaluation of NSAIDs (nonsteroidal anti-inflammatory drugs) consumption as rescue dose during the first 24 hours after cesarean delivery		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.	Yes