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临床试验/NCT03154658
NCT03154658已完成4 期

Serratus Anterior Plane Block: Sub-Serratus vs Supra-Serratus Plane Block for Pain Control in Patients Undergoing Mastectomy

University of Texas Southwestern Medical Center1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2017年4月1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
已完成
入组人数
66
试验地点
1
主要终点
Opioid Consumption

研究概览

简要总结

This is a randomized, interventional prospective study. Patients (n=66) undergoing mastectomies with or without tissue expander will be randomized to receive a supra-serratus or sub-serratus regional plane block prior to surgery. The main effect to be measured is total opioid consumption 24 hours after the operation. Secondary endpoints include measuring a change between pre-and post-operative pain scores, patient satisfaction of pain control during first 24 hours after the operation, presence of postoperative nausea and vomiting, duration of sleep on first postoperative night, and block performance time and length of stay, between the two treatment arms.

详细描述

Subjects will be randomized to one of two groups: the supra-serratus anterior plane block (depositing local anesthetic superficial to the serratus anterior muscle) or the sub-serratus anterior plane block (depositing local anesthetic deep to the serratus anterior muscle). Randomization will be performed using a computer generated randomization program. The results of the randomization will be revealed to the physician performing the block just prior to its performance. The site of the block will be marked and a safety timeout will be performed with the block nurse, regional anesthesiologist, and patient present and participating.

Once the above is completed, patients will receive a pre-operative ultrasound-guided single-injection serratus anterior plane block using either the supra-serratus or sub-serratus techniques according to their randomization. The block nurse will record the time when the timeout is performed, the "needle insertion" time when the block needle enters the skin, and the "block complete" time when the needle exits the skin. If the block is bilateral, the block nurse will record the time when the timeout is performed, then will record two sets of "needle in" times and "needle out" times, one for each side. In the case of a bilateral block, the same method of serratus anterior plane block will be utilized for both sides.

After the block, the patient will proceed to surgery. The operating room anesthesia team will be notified that the patient received a serratus anterior plane block. An appropriate multimodal general anesthetic will be employed at the operating room anesthesiologist's discretion. Upon completion of the surgery and emergence from general anesthesia, the patient will be seen by study personnel in the Post Anesthesia Care Unit and pain will be evaluated using a 0-10 Likert scale (0=no pain, 10= worst imaginable pain) about 1 hour post-operatively. Pain will be evaluated again by study personnel using the same scale on post-operative day #1, about 24 hours after initial block placement. If the patient is discharged home prior to the post-operative day #1 assessment, a phone interview will be performed 24 hours following the block to evaluate the post-operative day #1 scores and monitor for adverse events. Additional pain scores will be documented in the electronic medical record by nursing staff per protocol, and will be collected by study personnel.

During the intraoperative and post-operative period, the patient will continue to receive an appropriate multimodal analgesic regimen as necessary to adequately control the pain. No pain control method will be withheld from the patient as a result of participating in the study.

Patient satisfaction scores will also be used as a measure to evaluate quality of perioperative pain management. These scores will be assessed on post-operative day #1 on a scale of 1 to 5 (Poor=1, Fair=2, Good=3 Very good=4, Excellent=5).

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients 18 years or older
  • Individuals undergoing either a mastectomy or mastectomy with tissue expander for which the anesthetic plan includes a serratus anterior plane block.

排除标准

  • Any known sensory deficit of the anterolateral chest wall.
  • Any local disorder of the skin or otherwise where blockade is to be performed which would prevent safe performance of the block
  • American Society of Anesthesiology classification greater than 3
  • Allergy to amide local anesthetic medications
  • Chronic pain conditions
  • Preoperative opioid use greater than 20 oral morphine equivalents per day
  • Any coagulation abnormality which would be a contraindication for block placement
  • Preoperative chronic renal dysfunction requiring renal replacement therapy or a serum creatinine greater than 1.4 mg/dL
  • Body mass index >50
  • Incarceration
  • Inability to understand study procedures including inability to understand the English language
  • Inability to provide adequate informed consent
  • Refusal to participate in the study

研究组 & 干预措施

Sub-serratus regional block

Experimental

A regional block using of ropivacaine 0.35% (30 mL will be used per side in patients weighing over 60 kg and 20 mL will be used in patients weighing less than 60 kg) will be administered to the injection site deep to the serratus anterior muscle.

干预措施: Ropivacaine 0.35% (Drug)

Supra-serratus regional block

Active Comparator

A regional block using of ropivacaine 0.35% (30 mL will be used per side in patients weighing over 60 kg and 20 mL will be used in patients weighing less than 60 kg) will be administered to the injection site superficial to the serratus anterior muscle.

干预措施: Ropivacaine 0.35% (Drug)

结局指标

主要结局

Opioid Consumption

时间窗: 24 hours post block

Measures number of milligrams morphine equivalents each subject receives

次要结局

  • Maximum Post-operative Pain Score(24 hours post block)
  • Patient Satisfaction Scale(24 hours post block)
  • Number of Participants With Nausea/Vomiting(24 hours post block)
  • Length of Stay(10 Days)
  • Sleep Duration Night of Postoperative Day 0(24 hours post block)
  • Block Performance Time(Time from procedure needle insertion until needle removal, estimate less than 5 minutes)

研究者

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

Anthony Machi

Assistant Professor

University of Texas Southwestern Medical Center

研究点 (1)

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