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

• Sponsor: S. Anna Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02801968
• Collaborator: (none)
• Enrollment: 62
• Location: 1
• Arms: 2
• Duration (Months): 5
• Patients Per Site Per Month: 12.3

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 62 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Apr 1, 2016
• Anticipated Primary Completion Date: Sep 1, 2016
• Anticipated Study Completion Date: Sep 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Pain evaluation with Numerical Rating Scale (NRS) [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 [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.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Osepdale Santa Maria delle Croci	Ravenna		Italy

Sponsors and Collaborators

• S. Anna Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ilaria Farinelli, Doctor, S. Anna Hospital
• ClinicalTrials.gov Identifier: NCT02801968
• Other Study ID Numbers: CEIIAV1574
• First Posted: Jun 16, 2016
• Last Update Posted: Jun 16, 2016
• Last Verified: May 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No

Study Results

No Results Posted as of Jun 16, 2016