Obstetrical Complications From Sedation During ParturitionPhase 3TAPBlockNCT01986049
Transversus Abdominis Plane (TAP) Block for Post Caesarian Pain
A Phase 3 study testing Bupivicaine in people with Obstetrical Complications From Sedation During Parturition, run by New York Presbyterian Brooklyn Methodist Hospital at 1 site in United States.
Trial summary
Adding TAP block with Bupivacaine may decrease the use of PCA bolus use after caesarean section for pain relief. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Obstetrical Complications From Sedation During Parturition
- What is being tested?
- Bupivicaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Aug 2013
- Phase
- Phase 3
- 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 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Healthy pregnant (ASA II) patients presenting for planned Cesarean delivery at New York Methodist Hospital under combined spinal epidural anesthesia
Who cannot join
- They are unable or are unwilling to take part in the study
- They have a history of allergy to any of the medications to be used in the study
- They have a history of drug abuse or chronic pain or opioid use
- They weigh less than 60kg
- They have a multiple gestation, placental disease, preeclampsia other disease of pregnancy
- They have a contraindication to neuraxial anesthesia (i.e., bleeding problems, bacteremia, etc.)
- They are unable to understand instructions or questions related to the study
- ASA III or IV
Trial locations and contacts
1 site in 1 country.
United States1 site
New Yoyk Methodist Hospital
Brooklyn, New York, 11215
About this study
Official title: Phase 3 Study Comparing Transversus Abdominis Plane Block After Caesarian Section Usin Bupivacaine 0.5% vs. Bupivacaine 0.25% vs. Placebo (Normal Saline).
Adding TAP block with Bupivacaine may decrease the use of PCA bolus use after caesarean section for pain relief.
Read the detailed description
Participants in the study will be randomized to TAP block with 0.5% or 0.25% bupivacaine or with placebo (normal saline).
The number of PCA bolus used within 24 hours post cesarean section will be compared between the groups.
- Being tested
- Bupivicaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivicaineDrug
| Study group | Role | What they receive |
|---|---|---|
| Bupivicaine 0.5% | Experimental | Drug Bupivacaine 0.5% Receives: Drug: Bupivicaine |
| Bupivicaine 0.25% | Experimental | Drug Bupivacaine 0.25% Receives: Drug: Bupivicaine |
| Normal Saline | Placebo comparator | Saline Normal Receives: Drug: Bupivicaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transversus Abdominis Plane (TAP) Block for Post Caesarean Pain
In Patient Controlled analgesia (PCA) system, the patient receives a preset dose of morphine by pressing a button on a computerized pump that is connected to an IV catheter. With PCA the patient may receive a small continuous flow of morphine and add more morphine as needed to provide a more constant level of comfort. In this study, we will compare the number of PCAs used by the participants in each arm
Measured: The first post operative 24 hours
Secondary outcomes (1)
Decrease in the pain score as measured by Visual Analog Scale (VAS)
Visual Analog Scale (VAS) is a numeric scale to measure the pain intensity from 0 to 10, where 0 = no pain, (1-3) = mild pain, (4-6) = moderate pain, and (7-10) = severe pain. The worst imaginable pain = 10
Measured: The first post operative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2013 (estimated)
- Study startFeb 2013
- Primary completionAug 2013
- Study completionAug 2013
Why it stopped: We never collected data or started to recruit participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstetrical Complications From Sedation During ParturitionStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York Presbyterian Brooklyn Methodist Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joel Yarmush, New York Presbyterian Brooklyn Methodist Hospital
- Investigators
- Jonathan Weinberg, MD, Study director, New York Methodist Hospital Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01986049
- Sponsor's protocol ID
- IRBNet # 367320
- Acronym
- TAPBlock
- Status last verified
- Aug 2019
- First submitted
- 7 Nov 2013
- Last updated
- 14 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Study Comparing Transversus Abdominis Plane Block After Caesarian Section Usin Bupivacaine 0.5% vs. Bupivacaine 0.25% vs. Placebo (Normal Saline).
- ClinicalTrials.gov ID
- NCT01986049
- Acronym / sponsor ID
- TAPBlock / IRBNet # 367320
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: We never collected data or started to recruit participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- New York Presbyterian Brooklyn Methodist HospitalUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 18 Nov 2013 (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.
Adding TAP block with Bupivacaine may decrease the use of PCA bolus use after caesarean section for pain relief.
Detailed description
Participants in the study will be randomized to TAP block with 0.5% or 0.25% bupivacaine or with placebo (normal saline).
The number of PCA bolus used within 24 hours post cesarean section will be compared between the groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bupivicaine 0.5% | Experimental | Drug: BupivicaineDrug Bupivacaine 0.5% |
| Bupivicaine 0.25% | Experimental | Drug: BupivicaineDrug Bupivacaine 0.25% |
| Normal Saline | Placebo comparator | Drug: BupivicaineSaline Normal |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy pregnant (ASA II) patients presenting for planned Cesarean delivery at New York Methodist Hospital under combined spinal epidural anesthesia
Key exclusion criteria (8 listed)
- They are unable or are unwilling to take part in the study
- They have a history of allergy to any of the medications to be used in the study
- They have a history of drug abuse or chronic pain or opioid use
- They weigh less than 60kg
- They have a multiple gestation, placental disease, preeclampsia other disease of pregnancy
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 |
|---|---|---|
| Bupivicaine | Drug | Bupivicaine 0.25%, Bupivicaine 0.5%, Normal Saline |
Primary outcome
Transversus Abdominis Plane (TAP) Block for Post Caesarean Pain
Time frame: The first post operative 24 hours
In Patient Controlled analgesia (PCA) system, the patient receives a preset dose of morphine by pressing a button on a computerized pump that is connected to an IV catheter. With PCA the patient may receive a small continuous flow of morphine and add more morphine as needed to provide a more constant level of comfort. In this study, we will compare the number of PCAs used by the participants in each arm
1 secondary outcome
Decrease in the pain score as measured by Visual Analog Scale (VAS)
Time frame: The first post operative 24 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2021.
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.
Jonathan Weinberg, MD study director
New York Methodist Hospital Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bupivicaine in people with Obstetrical Complications From Sedation During Parturition, run by New York Presbyterian Brooklyn Methodist Hospital at 1 site in United States.
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 1 inclusion and 8 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: withdrawn, as of the sponsor's last update on 14 Oct 2021. 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 United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transversus Abdominis Plane (TAP) Block for Post Caesarean Pain (time frame: The first post operative 24 hours). 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 14 Oct 2021.