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临床试验/NCT03261193
NCT03261193终止3 期

QL Block for Post-cesarean Delivery Pain

Nicholas Schott1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2017年9月5日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
终止
发起方
入组人数
21
试验地点
1
主要终点
Visual Analogue Scale (VAS) Pain Score With Movement

研究概览

简要总结

Comparison of standard post-operative cesarean surgery pain management with regional post-op pain control.

详细描述

The purpose of this trial is to determine the efficacy of a postoperative analgesia strategy that incorporates quadratus lumborum block (QLB) in conjunction with a multi-modal post-cesarean analgesia strategy. The investigators hypothesize that QLB will provide superior post-cesarean analgesia compared to the current standard of care, multi-modal analgesia.

Thus, analgesia following cesarean section using QLB compared to the current standard of care alone will be further investigated. Current practice for cesarean surgical intervention consists of multi-modal analgesia (i.e., Intrathecal morphine (ITM) and scheduled post-operative non-opioid oral analgesics, with oral opioid analgesics reserved for breakthrough pain).

Investigators will measure side-effects associated with each strategy: Standard of care methods consisting of intrathecal morphine (ITM) plus scheduled non-opioid analgesics in conjunction with prn opioid analgesics for breakthrough pain will be utilized for both. The experimental treatment arm will entail standard of care in addition to QLB. The sham comparator will entail standard of care in addition to QLB with saline.

For each strategy, we will measure and model associated economic ramifications; such factors will include drug costs, procedure costs, and costs associated with length of stay and re-admissions.

The quadratus lumborum block (QLB) is similar to the transversus abdominis plane (TAP) block, but differs slightly in regards to the anatomical region where local anesthetic is injected. Since the quadratus lumborum (QL) is more posteriorly located, it theoretically confers greater safety due to enhanced visualization. The TAP block has been studied extensively for post-cesarean delivery pain, consistently showing that it is not superior to ITM for post-operative analgesia; however, it may prove to be helpful in patients with breakthrough pain despite the use of ITM, or in patients who were unable to receive ITM (e.g. general anesthesia for cesarean, contraindications to neuraxial morphine). Thus, ITM is superior to TAP alone for post-cesarean analgesia, but it is associated with a dose-dependent increased risk for opioid related side effects. In 2015, Blanco et. al. published a study specifically using the QLB for postoperative pain after cesarean delivery. In this study, they compared a true QLB to a sham QLB all in patients who did not receive ITM, and found that the QLB provided improved pain control and decreased the need for post-operative opioids. Another study in 2016 demonstrated that the QLB is superior to the TAP block in regards to decreasing post-operative pain following c-section. Unfortunately, neither study compared the QLB to ITM (part of the current gold standard for post-cesarean delivery pain, multimodal analgesia).

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
Single (Participant)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Elective cesarean planned under spinal anesthesia
  • Singleton pregnancy
  • American Society of Anesthesiologists (ASA) classification score of 2 (or less)
  • Gestational age of at least 37 weeks
  • Intention to breastfeed infant

排除标准

  • Contraindications to neuraxial blockade (such as clinically relevant coagulopathy, recent anticoagulant use, patient refusal, or localized skin infection overlying the site of needle entry)
  • Anatomical abnormalities contraindicating spinal or QLB placement
  • Received/Conversion to general anesthesia
  • Received supplemental parenteral anesthesia (sedation) for any reason (e.g. unanticipated prolonged surgical procedure)
  • History of chronic pain
  • History of chronic opioid use/abuse
  • History of Subutex, methadone, other maintenance therapy

研究组 & 干预措施

ITM + Sham QLB

Sham Comparator

Standard spinal with intrathecal morphine for surgical anesthetic with sham saline block. Saline will be administered as a quadratus lumborum block prior to cesarean section.

干预措施: ITM + Sham QLB (Drug)

ITM + Bupivacaine QLB

Experimental

Standard spinal with intrathecal morphine for surgical anesthetic with ql block with bupivacaine local anesthetic. Interventional drug will be administered prior to cesarean section.

干预措施: ITM + Bupivacaine QLB (Drug)

结局指标

主要结局

Visual Analogue Scale (VAS) Pain Score With Movement

时间窗: 24 hours after surgical procedure (cesarean delivery)

Post-operative pain accompanied with patient movement will be measured using a 10-point pain scale (VAS). The VAS scale is measured with 0=no pain at all and 10=most severe pain possible.

次要结局

  • Breast Feeding Success/Quality(24-hours post-operatively)
  • Visual Analogue Scale (VAS) Pain Score at Rest(48 hours after intervention)
  • First Request for Pain Medication(From post-operative until the patient is either withdrawn from the study or requests analgesic medication up until 72 hours)
  • Sedation(24-hours post-operative)
  • Heart Rate(48-hours post-operative)
  • Diastolic Blood Pressure(48-hours post-operative)
  • Oxygen Saturation(4-hours post-operative)
  • Pruritis(48-hours post-operative)
  • Nausea/Vomiting(48-hours post-operative)
  • Systolic Blood Pressure(48-hours post-operative)
  • Respiratory Rate(48-hours post-operative)

研究者

发起方
Nicholas Schott
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Nicholas Schott

Anesthesiologist

University of Pittsburgh

研究点 (1)

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