Dose Escalation of Dexamethasone to Increase Duration of Transversus Abdominal Plane Block Following Cesarean Section

NCT03098420 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2021-06-18

Study results available
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Summary

The study aims to improve the care of the obstetric population after cesarean section and improve total patient satisfaction by improving post-surgical pain control with the use of dexamethasone in combination with bilateral TAP blocks. The investigators will utilize a dose-escalation of dexamethasone in the TAP block to observe its effects at specific small doses. It is the hope of the investigator that the studied technique would become utilized routinely for the obstetric population following cesarean section.

The investigators hope to show that the addition of dexamethasone in bilateral TAP blocks will prolong the duration of the block in a dose-dependent fashion. The investigators hope to improve post-operative pain following cesarean section, increase duration of TAP block with use of dexamethasone, decrease overall pain scores in the first 24-48 hours, and decrease opioid requirements after cesarean section.

The primary endpoint will be estimation of duration of TAP block, being assessed within 48 hours after surgery. Secondary endpoints will include pain scores both in PACU and on the floor, average pain scores, time until first opioid administration, total opioid consumption in first 48 hours, use of PONV medications, and overall patient satisfaction.

Conditions

  • Post Surgical Pain

Interventions

DRUG

2mg Dexamethasone

0.5 mL (2mg) of dexamethasone and 0.5 ml of normal saline

DRUG

4mg Dexamethasone

1 mL (4mg) of dexamethasone

DRUG

Ropivacaine (TAP blocks)

20mL of 0% ropivacaine with 20mL of 0.5% ropivacaine

DRUG

Morphine

DRUG

Bupivacaine Hydrochloride

DRUG

Normal saline 1ml

1.0 ml of normal saline split between 2 sites with standard intrathecal bupivacaine and morphine

DRUG

Normal saline 0.5ml

0.5 ml of normal saline split between 2 sites with standard intrathecal bupivacaine and morphine

Sponsors & Collaborators

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • Joel Feinstein, MD · Anesthesiology ad Perioperative Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2021-05-20
Completion
2021-05-20
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03098420 on ClinicalTrials.gov