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临床试验/NCT07192198
NCT07192198已完成2 期

Efficacy of Inhaled Methoxyflurane (Penthrox) as Adjunct for Urologic Procedures Under Local Anesthetic: A Pilot Study

University of Manitoba1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年4月17日最近更新:
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
40
试验地点
1
主要终点
Pain with local anesthetic infiltration

研究概览

简要总结

We wish to perform a prospective randomized controlled pilot study at the Men's Health Clinic and Health Science's Centre to assess whether or not the use of Penthrox as an adjunct to LA is associated with improved pain tolerance and anxiety levels than local anesthetic alone

详细描述

This non-blinded, randomized controlled trial is to be conducted at both the Men's Health Clinic and Health Sciences Centre in Winnipeg, Manitoba. All eligible patients between the ages of 18-65, undergoing andrology and male infertility under local anesthetic or select endourology procedures under loco-sedation, will be invited to participate in the study. Patients will be excluded if; history of substance use disorder, history renal impairment, history of liver dysfunction, previous hypersensitivity to Penthrox or related agents, personal or family history of malignant hypothermia. They will be randomly assigned in a 1:1 ratio using a computer-generated random list. For penoscrotal cases, patient will be randomized to Penthrox + local infiltration of 50/50 lidocaine and bupivacaine mixture vs local infiltration alone. For select endourology procedures, patients will be randomized to Penthrox + topical local anesthetic vs IV sedation + topical anesthetic. Participants may begin using the Penthrox 10 minutes prior to procedure start given its median time of onset of 5 minutes. In the post-operative recovery area, patient will be asked to complete a questionnaire related to pain and anxiety of procedure.

Baseline characteristics such as age, use of analgesics, prior history of procedure under loco-sedation, history of chronic pain, baseline pain level (Brief Pain Inventory), pre-procedural anxiety (State Trait Anxiety Inventory) will be collected.

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
Double (Participant, Care Provider)

盲法说明

The surgeon and patient are both blinded to which cream is being utilized, whether it be Penthrox, or a control. Investigators and study personnel are not blinded to this.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Adult patients undergoing hydrocelectomy, spermatocelectomy, epididymectomy, testicular biopsy, scrotal lesion or cyst excision under local anesthesia alone will be included.

排除标准

  • Patients will be excluded if their procedure was to be performed with sedatives (e.g., inhaled nitrous oxide gas, oral, or IV sedation) or did not provide consent to be randomized

研究组 & 干预措施

Intervention arm-Penthrox

Experimental

Participants can begin using penthrox 10 minutes prior to procedure start, given its median onset time of 5 minutes

干预措施: Methoxyflurane (Drug)

Control arm

Placebo Comparator

Patients in the control arm will only receive local infiltration.

干预措施: Control (Other)

结局指标

主要结局

Pain with local anesthetic infiltration

时间窗: Immediately post-infiltration, intraoperatively

Using a visual analogue pain scale \[range 0-10; 0 = no pain, 10 = maximal pain\], pain will be assessed as reported by the patient when the local anesthetic injection is administered

Procedural pain

时间窗: Immediately post-operation

Using a visual analogue pain scale \[range 0-10; 0 = no pain, 10 = maximal pain\], pain will be assessed as reported by the patient post-operatively to determine their pain

次要结局

未报告次要终点

研究者

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

Premal Patel, MD

Assistant Professor, Department of Surgery. Director, Undergraduate Urologic Medical Education

University of Manitoba

研究点 (1)

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