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Transversus Abdominis Plane (TAP) Block for Post Caesarian Pain

Phase 3 Study Comparing Transversus Abdominis Plane Block After Caesarian Section Usin Bupivacaine 0.5% vs. Bupivacaine 0.25% vs. Placebo (Normal Saline).

Status
Withdrawn
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01986049
Acronym
TAPBlock
Enrollment
0
Registered
2013-11-18
Start date
2013-02-28
Completion date
2013-08-31
Last updated
2021-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstetrical Complications From Sedation During Parturition

Brief summary

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.

Interventions

Sponsors

New York Presbyterian Brooklyn Methodist Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

Healthy pregnant (ASA II) patients presenting for planned Cesarean delivery at New York Methodist Hospital under combined spinal epidural anesthesia

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Transversus Abdominis Plane (TAP) Block for Post Caesarean PainThe first post operative 24 hoursIn 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

Secondary

MeasureTime frameDescription
Decrease in the pain score as measured by Visual Analog Scale (VAS)The first post operative 24 hoursVisual 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026