Cesarean DeliveryTAPFANSNCT02801968
Tap Block and Cesarean Delivery: Efficacy and Consumption of Postoperative Drugs
A study testing Tap block and intravenous analgesia in people with Cesarean Delivery, run by S. Anna Hospital at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cesarean Delivery
- What is being tested?
- Tap block and intravenous analgesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2016to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age > 18 years
- written consent
- anesthesiologist's assent on preoperative evaluation
Who cannot join
- age< 18 years
- uncooperative patients
- written consent not obtained
- local anesthetic allergy
- BMI > 35
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Osepdale Santa Maria delle Croci
Ravenna, Ravenna
Riccardo Ragazzi, +390532236306, rgc@unife.it
Ilaria Farinelli
About this study
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.
- Conditions
- Cesarean Delivery
- Being tested
- Tap block, intravenous analgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tap blockProcedure or surgery
intravenous analgesiaOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Tap block; Other: intravenous analgesia |
| control group | Active comparator | Postoperative analgesia after cesarean delivery with acetaminophen and tramadol plus NSAIDs (nonsteroidal anti-inflammatory drugs) as rescue dose. Receives: Other: intravenous analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2016 (estimated)
- Study startApr 2016
- Primary completionSep 2016 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean DeliveryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- S. Anna Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilaria Farinelli, S. Anna Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02801968
- Sponsor's protocol ID
- CEIIAV1574
- Acronym
- TAPFANS
- Status last verified
- May 2016
- First submitted
- 28 May 2016
- Last updated
- 16 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tap Block and Cesarean Delivery: Efficacy and Consumption of Postoperative Drugs
- ClinicalTrials.gov ID
- NCT02801968
- Acronym / sponsor ID
- TAPFANS / CEIIAV1574
- Conditions
- Cesarean Delivery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- S. Anna HospitalUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 16 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tap block | Experimental | Procedure: Tap block, Other: intravenous analgesiaTap 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. |
| control group | Active comparator | Other: intravenous analgesiaPostoperative analgesia after cesarean delivery with acetaminophen and tramadol plus NSAIDs (nonsteroidal anti-inflammatory drugs) as rescue dose. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age > 18 years
- written consent
- anesthesiologist's assent on preoperative evaluation
Key exclusion criteria (5 listed)
- age< 18 years
- uncooperative patients
- written consent not obtained
- local anesthetic allergy
- BMI > 35
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tap block | Procedure or surgery | Tap block |
| intravenous analgesia | Other | Tap block, control group |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tap block and intravenous analgesia in people with Cesarean Delivery, run by S. Anna Hospital at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ilaria Farinelli (+393332082120, ilaria.farinelli@unife.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2016.