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临床试验/NCT05276258
NCT05276258Enrolling By Invitation不适用

A Randomized Controlled Trial of cryoSPHERE (CRYOS/CRYOS-L) Ablation of Intercostal Nerves for Post-Operative Pain Management in Opioid-Tolerant Patients Undergoing Robotic-Assisted Thoracoscopic Surgery

The Methodist Hospital Research Institute1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2023年2月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
75
试验地点
1
主要终点
Opioid Use Within 24 Hours After Chest Tube Removal

研究概览

简要总结

The main objective study is to compare the use of the cryoSPHERE probe to the standard-of-care method for pain management of patients receiving robotic-assisted thoracoscopic surgery, including reductions in opioid pain medication use and the development of post-surgical morbidity.

详细描述

Patients who take more opioid medications after surgery tend to have longer hospital stays, and they are at risk of developing pneumonia and other postoperative morbidities. Opioid-tolerant patients are at a higher risk of developing these morbidities because they often require higher doses of opioid medications to manage their post-operative pain. Reducing post-operative pain in these patients through non-opioid means helps reduce their risk of developing morbidities, and is potentially a more effective form of pain management, particularly in this patient population.

This is a single-center, prospective cohort registry with a historical control, and an estimated duration of 2 years. This study's primary objective is to evaluate the cryoSPHERE probe for ablation in pain control after surgery (measured using opioid medication). The secondary objectives are the evaluation of morbidities, length of stay, cost, and incidence of neuroma formation.

We plan to recruit 75 patients who will receive the cryoSPHERE probe and compare them to 75 patients who did not receive the cryoSPHERE probe. The experimental group will receive cryoSPHERE ablation of intercostal nerves and liposomal bupivacaine. The historical control group will have had robotic-assisted thoracoscopic surgery and an intercostal nerve block with liposomal bupivacaine and no cyroSPHERE probe.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male and female patients 18-90 years of age
  • Diagnosis requiring robotic-assisted thoracoscopic surgery
  • Daily opioid use for at least 30 days consecutively at any point during the last 12 months prior to surgery or using opioids at the time of study enrollment
  • Experimental group only: agreement and consent to comply with all aspects of the study protocol and data collection, including follow-up contact.

排除标准

  • Previous major surgery at the operative site (thoracotomy)
  • Allergy to aluminum
  • Allergy to plastics
  • Allergy to bupivacaine
  • Shingles disease
  • Demyelinating illnesses
  • Involvement with other interventional studies

研究组 & 干预措施

Nerve Block Using Liposomal Bupivacaine and cryoSPHERE Ablation

Experimental

The experimental group (75 participants) will undergo intercostal nerve block using liposomal bupivacaine and the cryoSPHERE ablation of intercostal nerves during robotic-assisted thoracoscopic operation at Houston Methodist Hospital.

干预措施: cryoSPHERE Ablation (Device)

Nerve Block Using Liposomal Bupivacaine and cryoSPHERE Ablation

Experimental

The experimental group (75 participants) will undergo intercostal nerve block using liposomal bupivacaine and the cryoSPHERE ablation of intercostal nerves during robotic-assisted thoracoscopic operation at Houston Methodist Hospital.

干预措施: Bupivacaine (Drug)

Historical Controls

Other

A total of 75 propensity score-matched historical controls will be selected from the pool of patients who had standard intercostal nerve block using liposomal bupivacaine alone at Houston Methodist Hospital from January 1, 2017 through January 1, 2022, inclusively.

干预措施: Bupivacaine (Drug)

结局指标

主要结局

Opioid Use Within 24 Hours After Chest Tube Removal

时间窗: From the time of chest tube removal to 24 hours after chest tube removal

Opioid use measured as the daily dose of milligram morphine equivalents (MME)

次要结局

  • Total Emergent Adverse Effects (TEAE)(Time of discharge (up to 1 year after surgery), 5 weeks after surgery, 3 months after surgery, and 6 months after surgery)
  • Opioid Use after Surgery(Day 1 after surgery, day 3 after surgery, 5 weeks after surgery, 3 months after surgery)
  • Mean Cost of Hospital Care(From admission to discharge or death, up to 1 year after surgery)
  • PROMIS8a Pain Interference(Time of discharge (up to 1 year after surgery), 5 weeks after surgery, 3 months after surgery, and 6 months after surgery)
  • Number of Readmissions(From initial admission for surgery to 28 days after surgery)
  • Length of Hospital Stay(From admission to discharge or death, up to 1 year after surgery)
  • Neuroma Formation(Time of discharge (up to 1 year after surgery), 3 months after surgery, and 6 months after surgery)
  • Pain Score(Time of discharge (up to 1 year after surgery), 5 weeks after surgery, 3 months after surgery, and 6 months after surgery)
  • PROMIS3a Pain Intensity(Time of discharge (up to 1 year after surgery), 5 weeks after surgery, 3 months after surgery, and 6 months after surgery)

研究者

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

Min P. Kim, MD

Distinguished Professor of Surgery

The Methodist Hospital Research Institute

研究点 (1)

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