Clinical trial NCT03098420: Dose Escalation of Dexamethasone to Increase Duration of Transversus Abdominal Plane Block Following Cesarean Section
Official title: Dose Escalation of Dexamethasone to Increase Duration of Transversus Abdominal Plane Block Following Cesarean Section: A Prospective Randomized Double-Blinded Clinical Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Post Surgical Pain
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2017-03-31
Enrollment: 29
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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.

Detailed description: Preoperatively: informed consent will be obtained by a member of this study. The patients will be screened for inclusion/exclusion criteria on day of procedure, and then the participants will be randomized to one of three groups.

Intraoperatively: The anesthesia team involved with care of patient in the operating room will provide routine anesthesia care during the cesarean section including neuraxial anesthesia with intrathecal bupivacaine and morphine.

After completion of the procedure, the patients will receive bilateral TAP block procedure while still in OR. All blocks will include 20mL of 0.5% ropivacaine, and the patients will be randomly assigned a specific dose of dexamethasone at 0mg (given normal saline as control), 2mg, or 4mg. The resident or attending physician supervising the block will be investigators of the study, and they along with the residents performing the blocks will be blinded to the amount of dexamethasone in the injectate.

Postoperatively: The patients will then be monitored in the PACU for approximately 30-60 minutes and then subsequently monitored on an inpatient floor. Pain scores, time until first opioid dose, total opioid requirement will be assessed and recorded. In PACU, these will be recorded every 15-30 minutes. On the inpatient floor, these will be recorded every 6 hours.

Pain scores, average pain scores in first 48 hours, total opioid consumption, time until first opioid use, and PONV medication requirement will also be recorded. These will be recorded by review of the electronic medical record.

Satisfaction scores and estimation of TAP block duration will be assessed and recorded by anesthesia personnel approximately 48 hours post-operatively; these will be subjective evaluations recorded between 24-38 hours postoperatively. The patients will be asked to estimate how long they felt the block lasted. For satisfaction scores, patients will rate their satisfaction subjectively on a scale of 1-10.

Statistical Analysis: all demographic and clinical variables with continuous measures will be expressed as means and standard deviations; categorical factors will be expressed as proportions. For non-normal data, the medians and inter quartile ranges will be displayed. The distribution of the continuous factors will be examined using the Kolmogorov-Smirnov test. For data that are normally distributed, one-way ANOVA will be used to compare groups of data. For data that are not normally distributed, the Kruskal-Wallis test will be used for comparisons. Chi-square and Fisher's exact tests will be used to analyze categorical data. For all comparisons, a value of p \< 0.05 will be considered statistically significant.

Statistical analyses will be performed using SAS for Windows, version 9.2. One-way ANOVA (or the Kruskal-Wallis test, as appropriate) will be used to compare duration of TAP block for the three groups. Linear regression will also be used to test the relationship between duration of block and dexamethasone dose, while controlling for relevant clinical and demographic variables.

One-way ANOVA (or the Kruskal-Wallis test) will be used to compare the groups on post-operative pain scores, opioid requirements, and patient satisfaction scores.

Statistical Power and Sample Size Estimates: Approximately 69 subjects (23 per group) are expected to be enrolled in this study. Given this sample size and assuming that the average duration of TAP block is 18 hours for the control group, 22 hours for the 2 mg of dexamethasone group, and 24 hours for the 4 mg of dexamethasone group, this study will have approximately 80.9% power to detect a difference in block duration, assuming a common standard deviation of 6 hours. If the variability in block time is smaller than 6 hours, this study will have greater power.

Eligibility 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

Primary outcomes:
measure: Average Pain Score
timeFrame: 48 hours postoperatively
Secondary outcomes:
measure: First Post-Operative Opioid Administration
timeFrame: baseline to 48 hrs postoperatively
measure: Average Opioid Consumption
timeFrame: from the time of delivery to 48hrs postoperatively
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB Department of Anesthesiology and Perioperative Medicine
state: Alabama
Study officials:
affiliation: Anesthesiology ad Perioperative Medicine
name: Joel Feinstein, MD
role: PRINCIPAL_INVESTIGATOR
References: