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临床试验/NCT03360214
NCT03360214已完成4 期

A Comparison of Pulsed Electromagnetic Fields (PEMF) and Pectoral (PEC) Interfascial Blocks on Postoperative Pain Reduction in Patients Undergoing Mastectomy and Tissue Expander Reconstruction

Columbia University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年7月5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
60
试验地点
1
主要终点
Score on Visual Analog Scale (VAS) - 1 Hour Post-intervention

研究概览

简要总结

This is a prospective randomized controlled double-blind interventional study comparing the effect of pulsed-electromagnetic field device (PEMF), pectoral interfascial block (PIB), and placebo on postoperative pain control. This study has the interdisciplinary cooperation of the regional anesthesia group, and the breast and plastic surgery divisions. All female patients with breast cancer evaluated at Columbia University Medical Center (CUMC) who are undergoing unilateral or bilateral mastectomy with tissue expander reconstruction will be offered enrollment in this prospective study.

详细描述

Chronic pain after mastectomy, or breast tissue removal, is very common with almost half of women experiencing some type of residual pain and even 13% characterizing it as severe. Poor acute postoperative pain control is not only associated with development of chronic pain, but has also been shown to be associated with delayed wound healing. Therefore, optimization of postoperative pain control is paramount not just for patient comfort, but to decrease immediate and long-term postoperative complications.

There are two adjunctive modes of perioperative pain control currently in use at Columbia University Medical Center (CUMC). The first mode uses pulsed electromagnetic fields (PEMF) and consists of a noninvasive device placed over dressings around the surgical site. The second is a regional anesthetic and -the pectoral interfascial block (PIB) in which a long-lasting local anesthetic (bupivacaine/ropivacaine) is injected into the surgical dissection area. Both of these techniques for postoperative analgesia have been shown to be effective in different types of breast surgery, but there is no current literature comparing the two modalities in their efficacy in reducing postoperative pain. There is also no current literature in their efficacy in the mastectomy and tissue expander patient population. The proposed trial is a prospective, randomized, controlled, double-blind trial to evaluate the efficacy of these two modalities of postoperative analgesia in patients undergoing mastectomy and tissue expander reconstruction.

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

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

入选标准

  • Subjects must be female
  • Subjects must be 18 years or older
  • Subjects must be undergoing unilateral or bilateral mastectomy with tissue expander reconstruction

排除标准

  • Allergy to all narcotic medications
  • Intake of any chronic opioids or pain medications preoperatively for a chronic condition or chronic use.

研究组 & 干预措施

Active PEMF + Treatment PIB

Other

Participants will receive an active device (Pulsed Electromagnetic Field (PEMF) Device) and active drug (Bupivacaine Hydrochloride or Ropivacaine HCl).

干预措施: Bupivacaine Hydrochloride (Drug)

Active PEMF + Treatment PIB

Other

Participants will receive an active device (Pulsed Electromagnetic Field (PEMF) Device) and active drug (Bupivacaine Hydrochloride or Ropivacaine HCl).

干预措施: Pulsed Electromagnetic Field (PEMF) Device (Device)

Active PEMF + Treatment PIB

Other

Participants will receive an active device (Pulsed Electromagnetic Field (PEMF) Device) and active drug (Bupivacaine Hydrochloride or Ropivacaine HCl).

干预措施: Ropivacaine Hydrochloride (Drug)

Active PEMF + Sham PIB

Other

Participants will receive an active device (Pulsed Electromagnetic Field (PEMF) Device) and placebo drug.

干预措施: Placebo Drug (Other)

Active PEMF + Sham PIB

Other

Participants will receive an active device (Pulsed Electromagnetic Field (PEMF) Device) and placebo drug.

干预措施: Pulsed Electromagnetic Field (PEMF) Device (Device)

Sham PEMF + Treatment PIB

Other

Participants will receive a placebo device and active drug (Bupivacaine Hydrochloride or Ropivacaine HCl).

干预措施: Bupivacaine Hydrochloride (Drug)

Sham PEMF + Treatment PIB

Other

Participants will receive a placebo device and active drug (Bupivacaine Hydrochloride or Ropivacaine HCl).

干预措施: Placebo Device (Other)

Sham PEMF + Treatment PIB

Other

Participants will receive a placebo device and active drug (Bupivacaine Hydrochloride or Ropivacaine HCl).

干预措施: Ropivacaine Hydrochloride (Drug)

Sham PEMF + Sham PIB

Other

Participants will receive placebo drug and placebo device.

干预措施: Placebo Drug (Other)

Sham PEMF + Sham PIB

Other

Participants will receive placebo drug and placebo device.

干预措施: Placebo Device (Other)

结局指标

主要结局

Score on Visual Analog Scale (VAS) - 1 Hour Post-intervention

时间窗: 1 hour post-intervention

Pain level will be measured using the VAS scale. Subjects will rate their pain level on a scale of 0-10. Number "0" indicates no pain and number "10" indicates terrible pain.

Score on Visual Analog Scale (VAS) - 3 Weeks Post-intervention

时间窗: 3 weeks post-intervention

Pain level will be measured using the VAS scale. Subjects will rate their pain level on a scale of 0-10. Number "0" indicates no pain and number "10" indicates terrible pain.

次要结局

  • Quality of Recovery Questionnaires (QoR) - 1 Hour Post-intervention(1 hour post-intervention)
  • Quality of Recovery Questionnaires (QoR) - 3 Weeks Post-intervention(3 weeks post-intervention)

研究者

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

Christine Hsu Rohde, MD

Professor of Plastic and Reconstructive Surgery

Columbia University

研究点 (1)

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