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临床试验/NCT03353363
NCT03353363Unknown4 期

A Comparison of Post-Incisional Wound Infiltration of Liposomal Bupivacaine to Plain Bupivacaine for Post-Operative Pain Control in Elective Cesarean Delivery: A Randomized Double Blind Placebo Controlled Trial

Brooke Army Medical Center1 个研究点 分布在 1 个国家目标入组 132 人开始时间: 2017年10月18日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
132
试验地点
1
主要终点
Post-operative Analgesia

研究概览

简要总结

Randomized double blind placebo controlled trial to compare the post-operative pain control advantages of post-incisional wound infiltration with liposomal bupivacaine to plain bupivacaine in patients presenting for elective caesarean delivery.

详细描述

Participants will include women with uncomplicated singleton pregnancies, ≥37 weeks gestation, ≥18 years old presenting and presenting for elective caesarean delivery with a planned spinal anesthetic with a standardized amount of intrathecal morphine (ITM). Exclusion criteria include patients: not receiving a spinal anesthetic, receiving a spinal anesthetic that required supplemental intraoperative pain medications (ketamine, epidural narcotics, intravenous narcotics, etc), on chronic opioids, American Society of Anesthesiologist (ASA) physical status class III or higher (Note: An ASA I patient is defined as a normal healthy patient, an ASA II patient is defined as a patient with mild systemic disease and any patient that with severe systemic disease or a disease that is incapacitating would be classified as an ASA III or higher) or those that have known hypersensitivity to bupivacaine hydrochloride, amide-type local anesthetics, or any component of the formation, and any subject with hepatic or renal impairment.

A three-arm study will be used: (a) control group (placebo of normal saline) (b) plain bupivacaine group and (c) liposomal bupivacaine group. After patients receive their spinal anesthetic and as the Pfannenstiel incision is being closed, an equal volume (20ml, administered via two 10ml syringes) of one of the three solutions will be infiltrated into the wound by the obstetrician team in a standardized fashion.

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)

盲法说明

Double-Blind Study

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

  • ASA I or II women with uncomplicated singleton pregnancies
  • ≥37 weeks gestation
  • ≥18 years old presenting
  • Presenting for elective caesarean delivery with a planned spinal anesthetic with a standardized amount of intrathecal morphine (ITM).
  • Able to provide informed consent.

排除标准

  • Subject is not a candidate for a spinal anesthetic
  • Subject receives a spinal anesthetic that required supplemental intraoperative pain medications (ketamine, epidural local anesthetic, epidural narcotics, intravenous narcotics, etc)
  • Subject is on chronic opioids.
  • Subject is an ASA class III or higher.
  • Subject has a known hypersensitivity to bupivacaine hydrochloride, amide-type local anesthetics, or any component of the formation,
  • Subject has hepatic or renal impairment that is concerning, as determined by the surgeon or anesthesiologist.

研究组 & 干预措施

Normal Saline

Placebo Comparator

Subject will receive 20ml of normal saline infiltration

干预措施: Placebos (Drug)

Plain Bupivacaine

Experimental

Subject will receive 20ml of 0.5% plain bupivacaine infiltration (100mg)

干预措施: Bupivacaine (Drug)

Liposomal Bupivacaine

Experimental

Subject will receive 20ml of liposomal bupivacaine infiltration (266mg) non-expanded

干预措施: Liposomal bupivacaine (Drug)

结局指标

主要结局

Post-operative Analgesia

时间窗: Thru 48 hours

VAS pain intensity scores (at rest)

次要结局

  • Length of Stay (LOS)(Thru 72 hours)
  • Time to first ambulation(Thru 72 hours)
  • Breast feeding initiation(Thru 72 hours)
  • Sole breastfeeding(Thru 72 hours)
  • Pain control at 2 hours post-cesarean delivery(Thru 2 hours)
  • Increased operative time(Thru 72 hours)
  • Wound Complication(14days post-operatively)
  • Opioid use in the post-operative period(Thru 72 hours)

研究者

申办方类型
Fed
责任方
Principal Investigator
主要研究者

Brian M. Fitzgerald, MD

Staff Anesthesiologist

Brooke Army Medical Center

研究点 (1)

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