Dose Escalation of Dexamethasone to Increase Duration of Transversus Abdominal Plane Block Following Cesarean Section: A Prospective Randomized Double-Blinded Clinical Study
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Average Pain Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
The anesthesia team that performs the block, along with the supervising PI or sub-investigator, will be blinded to the medication in the injectate.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •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
- •Emergency Cesarean Sections
研究组 & 干预措施
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.
干预措施: Ropivacaine (TAP blocks) (Drug)
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.
干预措施: Morphine (Drug)
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.
干预措施: Bupivacaine Hydrochloride (Drug)
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.
干预措施: Normal saline 1ml (Drug)
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.
干预措施: 2mg Dexamethasone (Drug)
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.
干预措施: Ropivacaine (TAP blocks) (Drug)
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.
干预措施: Morphine (Drug)
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.
干预措施: Bupivacaine Hydrochloride (Drug)
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.
干预措施: Normal saline 0.5ml (Drug)
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.
干预措施: 4mg Dexamethasone (Drug)
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.
干预措施: Ropivacaine (TAP blocks) (Drug)
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.
干预措施: Morphine (Drug)
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.
干预措施: Bupivacaine Hydrochloride (Drug)
结局指标
主要结局
Average Pain Score
时间窗: 48 hours postoperatively
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.
次要结局
- Average Opioid Consumption(from the time of delivery to 48hrs postoperatively)
- First Post-Operative Opioid Administration(baseline to 48 hrs postoperatively)
研究者
Joel Feinstein, MD
Principal Investigator
University of Alabama at Birmingham