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
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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