Transversus Abdominis Plane (TAP) Block for Post Caesarian Pain

Obstetrical Complications From Sedation During Parturition Clinical Trial

— TAPBlock  

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).

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01986049
• Other study ID #: IRBNet # 367320
• Status: Withdrawn
• Phase: Phase 3
• Start date: February 2013
• Est. completion date: August 2013

Study information

• Verified date: August 2019
• Source: New York Presbyterian Brooklyn Methodist Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Adding TAP block with Bupivacaine may decrease the use of PCA bolus use after caesarean section for pain relief.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Obstetrical Complications From Sedation During Parturition

Intervention

Drug:
• Bupivicaine

Locations

Country	Name	City	State
United States	New Yoyk Methodist Hospital	Brooklyn	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York Presbyterian Brooklyn Methodist Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The first post operative 24 hours
Secondary	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	The first post operative 24 hours