Intrathecal Hydromorphone for Postoperative Pain of Anorectal Surgery: A Randomized, Double-blind, Parallel, Placebo-controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Numerical Rating Scale Pain Scores (NRS score for pain)
研究概览
简要总结
Anorectal problems, such as hemorrhoids, fistula, fissures, Etc., often require surgical treatment. Patients often have postoperative pain after these surgeries, which increases discomfort and hospital length of stay. The efficacy of oral non-opioids in the treatment of such pain is poor. Hydromorphone is an opioid analgesic commonly used orally or intravenously for postoperative pain management. We designed this trial to investigate the efficacy and safety of intrathecal (delivery directly to the spinal cord during spinal anesthesia) single dose hydromorphone versus intrathecal placebo in treating postoperative pain among human subjects after anorectal surgery, but also the recovery of postoperative motor capacity in these human subjects.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical Diagnosis of anorectal disease, ready to undergo elective surgery
- •American Society of Anesthesiologists(ASA) physical status I-II
- •Desire to have a spinal anesthesia
- •Must be able to follow the medication dose and visit schedule
排除标准
- •Any contraindications to spinal anesthesia and intrathecal analgesia.
- •Complex co-morbidities, including
- •Severe infection,
- •Respiratory insufficiency,
- •History of psychiatric or neurological disorders and other cognitive impairments
- •Chronic pain syndrome or current opioid use >10mg oral morphine equivalents/day
- •Allergy or intolerance to hydromorphone, NSAIDs and Cox-2 selective Inhibitor
- •Clinical diagnosis of obstructive sleep apnea syndrome(OSAS)
- •History of drug abuse
- •Women who are breastfeeding or pregnant
- •Participation in other clinical trials within three months
- •Already participated in this study once
- •Not considered suitable for the clinical trial by the investigators
研究组 & 干预措施
Intrathecal Hydromorphone Group (ITHM)
Dosage Form: Hydromorphone Hydrochloride Injection 2mg:2ml. Dosage: 75 μg+ 5% glucose injection diluted to 1.5ml. Frequency and Duration: i.t., st
干预措施: Intrathecal Hydromorphone Mono Injection (Drug)
Intrathecal Placebo Group (ITPO)
Dosage Form: 5% glucose injection, 100ml/Package. Dosage: 1.5ml. Frequency and Duration: i.t., st
干预措施: Intrathecal Placebo Mono Injection (Drug)
结局指标
主要结局
Numerical Rating Scale Pain Scores (NRS score for pain)
时间窗: Time of spinal injection finished will be noted as time: "0". NRS, with movement 12 hours, will be collected by patient interview at 12 hours after spinal administration.
NRS for pain (0-10) with movement 12 hours after spinal administration
次要结局
- NRS score at rest/with movement(Time of spinal injection finished will be noted as time: "0". NRS, with movement or at rest, will be collected by patient interview at 1, 3, 6, 12, 24 and 36 hours after spinal administration.)
- Severity and incidence of any opioid-related complication at each time point(All data will be collected by patient interview at 1, 3, 6, 12, 24 and 36 hours after spinal administration.)
- Highest pain NRS (0-10) in previous 12 hours(At 12 hours after spinal administration.)
- Total non-opioid analgesic consumption(All data will be collected by patient interview at 12, 24 and 36 hours after spinal administration.)
- Quality of Recovery Scale (QoR)(At 12, 24 and 36 hours post spinal administration.)
- Recovery of lower extremity strength.(Data will be collected by patient interview at 12 hours after spinal administration.)