跳至主要内容
临床试验/NCT03236324
NCT03236324已完成2 期

Efficacy of Ultrasound-guided Transversalis Fascia Plane Blocks for Post-cesarean Section Analgesia: a Randomized Double Blinded Control Study

University of Calgary1 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2017年9月22日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
106
试验地点
1
主要终点
Postoperative opioid consumption

研究概览

简要总结

The aim of this study is to assess the efficacy of a bilateral TFP block in parturients undergoing cesarean delivery (CD) by evaluating postoperative opioid consumption and numeric rated pain scores in two groups (TFP block with saline (control) and TFP block with local anesthetic (treatment)). Women (American Society of Anesthesiologists physical status Class 1-3) at term gestation with singleton pregnancies undergoing an elective CD under spinal anesthesia at the South Health Campus will be consented to participate in the study. Patients will be randomly assigned using a computer-generated table of random numbers to two groups. Group allocations will be concealed. All patients will receive spinal anesthesia with spinal Morphine according to our institutional protocol. At the end of surgery, randomized patients will receive either ultrasound-guided bilateral TFP blocks with 0.25% bupivacaine with 2.5 mcg/ml epinephrine 40 ml total or maximum 2.5 mg/kg (Group 1) or 40 mL saline (Group 2) by 2 anesthesiologists experienced in performing this block.

详细描述

Caesarean delivery (CD) is one of the most commonly performed surgical procedures with an estimated annual frequency of 27% in Alberta between 2007-2011. Poorly controlled postsurgical pain is associated with an increase in morbidity. Untreated or undertreated pain can lead to respiratory infections secondary to splinting and shallow breathing. Excessive pain also reduces and delays ambulation, which can lead to both an increase in the incidence of deep vein thrombosis (DVT) and delay recovery and readiness for discharge. Poorly controlled pain may also lead to the development of chronic postsurgical pain. The optimal form of postoperative analgesia following CD is not known. Most postoperative analgesic protocols for CD, despite being multimodal in nature, rely heavily on opioid medications both orally and intrathecally for analgesia. These medications, however, are not without serious side effects such as nausea, vomiting, sedation, addiction or dependence, and respiratory depression as well as expression in breast milk which may put infants at risk of side effects as well. Thus, an effective alternative analgesic modality analgesia in these patients which produces both improved pain control and reduced side effects is desired. The TFP block represents a promising alternative, which may fulfill this role in complementing multimodal analgesia for patients undergoing CD and reducing opioid administration.

This project aims to elucidate information regarding alternative interventions for postoperative analgesia following CD. While the most common analgesic regimen of intrathecal and oral opioids, acetaminophen, and NSAIDS for postoperative analgesia is effective, it is not appropriate for all patients. For those who cannot receive intrathecal opioids (e.g. those with allergies to opioid medications, or those who are undergoing CD under general anesthetic), alternative analgesic modalities are important to provide adequate multimodal analgesia and minimize side effects of each of the analgesic medications. Additionally, this aforementioned common analgesic pathway may itself be further optimized through the addition of new analgesic techniques. The Transversalis Fascia Plane (TFP) block is a nerve block, which could potentially target nerves responsible for transmitting pain following CD, and represents a promising novel analgesic modality.

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
Triple (Participant, Care Provider, Investigator)

入排标准

性别
Female
接受健康志愿者

入选标准

  • elective Cesarean delivery with spinal anesthesia at South Health Campus
  • term gestation with a singleton pregnancy
  • American Society of Anesthesiologists' (ASA) physical status Class 1-3

排除标准

  • language barrier
  • body mass index (BMI) > 40 kg/m2
  • multiple gestations
  • chronic pain
  • opioid use
  • substance abuse
  • allergies to study medication

研究组 & 干预措施

TFP block with saline

Placebo Comparator

Placebo bilateral ultrasound-guided nerve block [transversalis fascia plane (TFP) block] with 40 mL saline, single shot

干预措施: ultrasound-guided nerve block (Device)

TFP block with saline

Placebo Comparator

Placebo bilateral ultrasound-guided nerve block [transversalis fascia plane (TFP) block] with 40 mL saline, single shot

干预措施: Saline (Drug)

TFP block with local anesthetic

Experimental

Experimental bilateral ultrasound-guided nerve block [transversalis fascia plane (TFP) block] with local anesthesic of Bupivacaine-epinephrine [0.25% bupivacaine with 2.5 mcg/mL epinephrine 40 mL (maximum 2.5 mg/kg)], single shot

干预措施: ultrasound-guided nerve block (Device)

TFP block with local anesthetic

Experimental

Experimental bilateral ultrasound-guided nerve block [transversalis fascia plane (TFP) block] with local anesthesic of Bupivacaine-epinephrine [0.25% bupivacaine with 2.5 mcg/mL epinephrine 40 mL (maximum 2.5 mg/kg)], single shot

干预措施: Bupivacaine-epinephrine (Drug)

结局指标

主要结局

Postoperative opioid consumption

时间窗: 24 hours

24-hour postoperative opioid consumption presented in morphine equivalents

次要结局

  • Patient satisfaction(48 hours)
  • Numeric rating scale pain scores(up to 48 hours)
  • Post-discharge numeric rating pain scale scores(up to 60 days)
  • Opioid side effects(48 hours)
  • Quality of recovery scores(up to 48 hours)
  • Time to first analgesia(48 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验