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

NCT03098420 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: F160421006
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Surgical Pain

Outcome Measures

Primary Outcomes (1)

• Average Pain Score

  Average pain score (VAS) 48 hrs postoperatively between the study group and the control. The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. 0 represents no pain, whereas 10 represents unbearable pain.

  48 hours postoperatively

Secondary Outcomes (2)

• First Post-Operative Opioid Administration

  baseline to 48 hrs postoperatively

• Average Opioid Consumption

  from the time of delivery to 48hrs postoperatively

Study Arms (3)

Control Group

PLACEBO COMPARATOR

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); Drug: Morphine; Drug: Bupivacaine Hydrochloride; Drug: Normal saline 1ml

2mg Dexamethasone

ACTIVE COMPARATOR

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; Drug: Ropivacaine (TAP blocks); Drug: Morphine; Drug: Bupivacaine Hydrochloride; Drug: Normal saline 0.5ml

4mg Dexamethasone

ACTIVE COMPARATOR

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; Drug: Ropivacaine (TAP blocks); Drug: Morphine; Drug: Bupivacaine Hydrochloride

Interventions

2mg Dexamethasone DRUG

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

Also known as: Baycadron, Maxidex, Decadron

2mg Dexamethasone

4mg Dexamethasone DRUG

1 mL (4mg) of dexamethasone

Also known as: Baycadron, Maxidex, Decadron

4mg Dexamethasone

Ropivacaine (TAP blocks) DRUG

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

2mg Dexamethasone; 4mg Dexamethasone; Control Group

Morphine DRUG

2mg Dexamethasone; 4mg Dexamethasone; Control Group

Bupivacaine Hydrochloride DRUG

2mg Dexamethasone; 4mg Dexamethasone; Control Group

Normal saline 1ml DRUG

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

Control Group

Normal saline 0.5ml DRUG

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

2mg Dexamethasone

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Females undergoing cesarean section delivery
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women undergoing cesarean section delivery.
• Patients classified as American Society of Anesthesiology (ASA) class II or III.
• ASA II: mild systemic disease, pregnancy
• ASA III: severe systemic disease
• Women ≥ 18 years old
• Neuraxial anesthesia (spinal) to be used as anesthetic technique intraoperatively for cesarean section (this is the UAB Anesthesiology standard of care).

You may not qualify if:

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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

UAB Department of Anesthesiology and Perioperative Medicine

Birmingham, Alabama, 35249, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Dexamethasone; Calcium Dobesilate; Ropivacaine; Morphine; Bupivacaine; Saline Solution

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Anilides; Amides; Aniline Compounds; Amines; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed, due to recruitment challenges related to competing studies in the women and infants center

Results Point of Contact

• Title: Dr. Joel Feinstein
• Organization: University of Alabama at Birmingham

jfeinstein@uabmc.edu

205-934-4696

Study Officials

• Joel Feinstein, MD

  Anesthesiology ad Perioperative Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The anesthesia team that performs the block, along with the supervising PI or sub-investigator, will be blinded to the medication in the injectate.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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

Study Record Dates

• First Submitted: March 13, 2017
• First Posted: March 31, 2017
• Study Start: July 1, 2016
• Primary Completion: May 20, 2021
• Study Completion: May 20, 2021
• Last Updated: June 18, 2021
• Results First Posted: June 18, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)