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临床试验/NCT03695172
NCT03695172终止4 期

Comparison of TAP, Anterior QL, or ESP Block for Elective Cesarean Section

Duke University1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2019年9月12日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
终止
入组人数
12
试验地点
1
主要终点
Postoperative Pain Scores

研究概览

简要总结

The purpose of this prospective single center, randomized study is to determine if ultrasound guided Transversus Abdominis Plane (TAP), Quadratus Lumborum (QL), and Erector Spinae Plane (ESP) blocks decrease opioid consumption in subjects undergoing elective cesarean section.

详细描述

The typical anesthetic for cesarean section at Duke University Hospital includes a spinal or combined spinal epidural anesthetic with intrathecal dosing of 1.4-1.6 mL bupivacaine HCl 0.75%, 15 mcg fentanyl, and 150 mcg morphine. If the epidural component of a combined spinal epidural anesthetic is used, the subject will be withdrawn from the study. Patients also receive rectal acetaminophen 975 mg prior to incision; intravenous (IV) ondansetron 4 mg, IV metoclopramide 10 mg, IV famotidine 20 mg and IV dexamethasone 4 mg intraoperatively; and IV ketorolac 15 mg prior to skin closure. There will be no change to this typical practice.

Patients who consent to be in this study will be randomized to receive one of three truncal nerve blocks using an online randomization program by the study PI (AK/EG): (1) ultrasound-guided bilateral classic TAP block; (2) ultrasound-guided bilateral anterior QL (also known as transmuscular or QL type 3) block; (3) ultrasound-guided bilateral ESP block at the level of T9. These nerve blocks will be performed after delivery and within one hour of skin closure with 25 mL of 0.2% ropivacaine with epinephrine 1:400,000 per side. Nerve blocks will be performed by a dedicated and trained group of regional anesthesiologists. This non-blinded regional anesthesiologist will save an ultrasound image after local anesthetic administration while the needle is still in position on each side. The study team will review these images to ensure a high quality of block performance.

Patients will have standard postoperative pain medication orders, including acetaminophen 975 mg PO Q6H for 4 days (scheduled, starting 6 hours after intraoperative rectal dose), ketorolac 15 mg IV Q6H for 24 hours (scheduled, starting 6 hours after intraoperative dose), ibuprofen 600 mg PO Q6H for 3 days (scheduled, starting 24 hours after first dose of ketorolac) and oxycodone 5-10mg PO Q3-4H PRN for 4 days. If patients are unable to tolerate oral medication or oxycodone is insufficient, rescue medications may be ordered: IV morphine 1-2 mg or IV hydromorphone 0.3-0.5 mg Q4H as needed. There is no change from the standard postoperative order sets used for patients after cesarean section.

Subjects' verbal pain scores at rest and with movement as well as opioid consumption will be recorded at 2, 6, 24, and 48 hours postoperatively. Additionally, the amount of antiemetics and antipruritics used will also be recorded at the above time points. These scores will be entered into a Duke University Hospital REDCap database. Subjects will also be sent a survey assessing their satisfaction with pain control one week after discharge via email or telephone. This information will be collected via Duke University Hospital REDCap.

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
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • American Society of Anesthesiologists (ASA) Physical Status 1-3
  • Age greater than or equal to 18 years
  • Scheduled for elective cesarean section
  • English speaking

排除标准

  • ASA Physical Status 4-5
  • Diagnosis of chronic pain
  • Chronic opioid use (opioid use in the past 3 months)
  • Preoperative use of SSRIs (Celexa, Lexapro, Prozac, Paxil), SNRIs (Cymbalta, Effexor), gabapentin, or pregabalin (Lyrica)
  • Inability to cooperate with or understand protocol
  • Inability to communicate pain scores or need for analgesia
  • Infection at the site of block placement
  • Intolerance or allergy to local anesthetics
  • Neurologic deficit or disorder
  • Blood thinning disorder or taking anticoagulant medication
  • BMI > 50 kg/m2
  • Suspected or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years
  • Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, may interfere with study assessments or compliance
  • Current or historical evidence of any clinically significant disease or condition that, in the opinion of the investigator, may increase the risk of surgery or complicate the subject's postoperative course

研究组 & 干预措施

TAP block

Active Comparator

Patients will receive bilateral TAP blocks after delivery and within one hour of skin closure with 25 mL of 0.2% ropivacaine with epinephrine 1:400,000 per side.

干预措施: Ropivacaine (Drug)

TAP block

Active Comparator

Patients will receive bilateral TAP blocks after delivery and within one hour of skin closure with 25 mL of 0.2% ropivacaine with epinephrine 1:400,000 per side.

干预措施: TAP block (Procedure)

QL block

Active Comparator

Patients will receive bilateral QL blocks after delivery and within one hour of skin closure with 25 mL of 0.2% ropivacaine with epinephrine 1:400,000 per side.

干预措施: Ropivacaine (Drug)

QL block

Active Comparator

Patients will receive bilateral QL blocks after delivery and within one hour of skin closure with 25 mL of 0.2% ropivacaine with epinephrine 1:400,000 per side.

干预措施: QL block (Biological)

ESP block

Active Comparator

Patients will receive bilateral ESP blocks after delivery and within one hour of skin closure with 25 mL of 0.2% ropivacaine with epinephrine 1:400,000 per side.

干预措施: Ropivacaine (Drug)

ESP block

Active Comparator

Patients will receive bilateral ESP blocks after delivery and within one hour of skin closure with 25 mL of 0.2% ropivacaine with epinephrine 1:400,000 per side.

干预措施: ESP block (Procedure)

结局指标

主要结局

Postoperative Pain Scores

时间窗: 48 hours postoperatively

Visual Analog Scale at rest with 0 being no pain and 10 being the worst pain imaginable

Postoperative Opioid Consumption

时间窗: 48 hours postoperatively

Amount of opioid

次要结局

  • Number of Participants Requiring Antipruritics(48 hours postoperatively)
  • Overall Satisfaction With Pain Control(1 week postoperatively)
  • Number of Participants Requiring Antiemetics(48 hours postoperatively)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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