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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03098420
Recruitment Status : Active, not recruiting
First Posted : March 31, 2017
Last Update Posted : March 12, 2020
Sponsor:
Information provided by (Responsible Party):
Joel Feinstein, MD, University of Alabama at Birmingham

Brief 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.


Condition or disease Intervention/treatment Phase
Post Surgical Pain Drug: 2mg Dexamethasone Drug: 4mg Dexamethasone Drug: Ropivacaine (TAP blocks) Drug: Morphine Drug: Bupivacaine Hydrochloride Drug: Normal saline 1ml Drug: Normal saline 0.5ml Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients will be randomly assigned to 1 of 3 groups. They will be assigned to a group prior to being brought back to the operating room. The anesthesia team in the OR will take an envelope that has which group the patient will be randomly assigned to and they will perform the TAP block with the respective dose of dexamethasone. The anesthesia team that performs the block, along with the supervising PI or sub-investigator, will be blinded to the medication in the injectate
Masking: Double (Participant, Investigator)
Masking Description: The anesthesia team that performs the block, along with the supervising PI or sub-investigator, will be blinded to the medication in the injectate.
Primary Purpose: Treatment
Official Title: Dose Escalation of Dexamethasone to Increase Duration of Transversus Abdominal Plane Block Following Cesarean Section: A Prospective Randomized Double-Blinded Clinical Study
Actual Study Start Date : July 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arm Intervention/treatment
Placebo Comparator: Control Group
20 patients. Each patient will receive postoperative bilateral TAP blocks (20mL of ropivacaine) and 1mL of normal saline bilaterally (control) with standard intrathecal bupivacaine and morphine.
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

Active Comparator: 2mg Dexamethasone
20 patients. Each patient will receive postoperative bilateral TAP blocks (20mL of 0.5% ropivacaine) with 0.5 mL (2mg) of dexamethasone and 0.5 ml of normal saline split between 2 sides with standard intrathecal bupivacaine and morphine.
Drug: 2mg Dexamethasone
0.5 mL (2mg) of dexamethasone and 0.5 ml of normal saline
Other Name: Baycadron, Maxidex, Decadron

Drug: Ropivacaine (TAP blocks)
20mL of 0% ropivacaine with 20mL of 0.5% ropivacaine

Drug: Morphine
Drug: Bupivacaine Hydrochloride
Drug: Normal saline 0.5ml
0.5 ml of normal saline split between 2 sites with standard intrathecal bupivacaine and morphine

Active Comparator: 4mg Dexamethasone
20 patients. Each patient will receive postoperative bilateral TAP blocks (20mL of 0.5% ropivacaine) with 20mL of 0.5% ropivacaine) and 1 mL (4mg) of dexamethasone between 2 sides with standard intrathecal bupivacaine and morphine.
Drug: 4mg Dexamethasone
1 mL (4mg) of dexamethasone
Other Name: Baycadron, Maxidex, Decadron

Drug: Ropivacaine (TAP blocks)
20mL of 0% ropivacaine with 20mL of 0.5% ropivacaine

Drug: Morphine
Drug: Bupivacaine Hydrochloride



Primary Outcome Measures :
  1. TAP c-section Block [ Time Frame: 24 - 48 hours postoperatively ]
    Mean duration of TAP block within 48 hrs postoperatively between the study group and the control


Secondary Outcome Measures :
  1. Total Pain Scores [ Time Frame: baseline to 48 hrs postoperatively ]
    Collection of pain scores(VAS) every 15 minutes in PACU then every 6 hours on inpatient floor until approximately 48 hours post-operatively.

  2. Average Pain Score [ Time Frame: 48 hours postoperatively ]
    Average pain score (VAS) 48 hrs postoperatively between the study group and the control

  3. First Post-Operative Opioid Administration [ Time Frame: baseline to 48 hrs postoperatively ]
    Time until first dose post-operative opioid administration between the study group and the control

  4. Average Opioid consumption [ Time Frame: 48hrs postoperatively ]
    Average opioid consumption 48 hrs postoperatively between the study group and the control

  5. PONV Medications [ Time Frame: baseline to 48 hrs post-operatively ]
    Mean time onset use of rescue PONV medications postoperatively between the study group and the control

  6. Patient Satisfaction [ Time Frame: 48 hrs postoperatively ]
    Patient satisfaction scores postoperatively between the study group and the control



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Females undergoing cesarean section delivery
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Women undergoing cesarean section delivery.
  2. Patients classified as American Society of Anesthesiology (ASA) class II or III.

    1. ASA II: mild systemic disease, pregnancy
    2. ASA III: severe systemic disease
  3. Women ≥ 18 years old
  4. Neuraxial anesthesia (spinal) to be used as anesthetic technique intraoperatively for cesarean section (this is the UAB Anesthesiology standard of care).

Exclusion Criteria:

  1. Any patient not classified as an ASA I or II.
  2. General Anesthesia or neuraxial anesthesia with epidural used as anesthetic techniques for cesarean section.
  3. Allergy/intolerance to local anesthetic or steroids.
  4. Pre-existing neurological and/or anatomical deficit that would preclude regional block.
  5. Coexisting coagulopathy such as hemophilia or von Willebrand Disease
  6. BMI > 40.
  7. Emergency Cesarean Sections

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03098420


Locations
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United States, Alabama
UAB Department of Anesthesiology and Perioperative Medicine
Birmingham, Alabama, United States, 35249
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
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Principal Investigator: Joel Feinstein, MD Anesthesiology ad Perioperative Medicine
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Responsible Party: Joel Feinstein, MD, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03098420    
Other Study ID Numbers: F160421006
First Posted: March 31, 2017    Key Record Dates
Last Update Posted: March 12, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Dexamethasone
Dexamethasone acetate
Morphine
Bupivacaine
Ropivacaine
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Analgesics, Opioid
Narcotics
Analgesics