NCT02801968

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 28, 2016

Completed
19 days until next milestone

First Posted

Study publicly available on registry

June 16, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

June 16, 2016

Status Verified

May 1, 2016

Enrollment Period

5 months

First QC Date

May 28, 2016

Last Update Submit

June 12, 2016

Conditions

Cesarean Delivery

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (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.

Study Arms (2)

Tap block

EXPERIMENTAL

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 blockOther: intravenous analgesia

control group

ACTIVE COMPARATOR

Postoperative analgesia after cesarean delivery with acetaminophen and tramadol plus NSAIDs (nonsteroidal anti-inflammatory drugs) as rescue dose.

Other: intravenous analgesia

Interventions

Tap blockPROCEDURE
Tap block
intravenous analgesiaOTHER
Tap blockcontrol group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Osepdale Santa Maria delle Croci

Ravenna, Ravenna, Italy

RECRUITING

Central Study Contacts

Ilaria Farinelli

CONTACT

+393332082120ilaria.farinelli@unife.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

May 28, 2016

First Posted

June 16, 2016

Study Start

April 1, 2016

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

June 16, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)