Postoperative Tizanidine Use in Pelvic Reconstructive Surgery: A Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 186
- 主要终点
- Patient Reported Outcome (PRO)
研究概览
简要总结
The goal of this clinical trial is to evaluate whether adding tizanidine to the standard postoperative pain regimen improves recovery after pelvic reconstructive surgery in adult women. The main questions it aims to answer are:
Does postoperative tizanidine improve patient-reported recovery 4-6 weeks after surgery? Does tizanidine reduce postoperative pain, opioid use, constipation, and healthcare utilization while improving functional recovery?
Researchers will compare standard postoperative care plus tizanidine with standard postoperative care alone to determine whether tizanidine improves postoperative recovery.
Participants will:
- Be randomly assigned to receive either standard postoperative pain management alone or standard postoperative pain management plus tizanidine for 2 weeks after surgery.
- Complete electronic surveys before surgery, 1-2 days after surgery, 2 weeks after surgery, and 4-6 weeks after surgery to assess pain, recovery, activity, and bowel function.
- Allow researchers to review information from their electronic medical record, including healthcare utilization and postoperative outcomes, during the 4-6 weeks following surgery.
详细描述
This pilot study evaluates the effectiveness of postoperative tizanidine as an adjunct to existing postoperative pain regimens for patients undergoing pelvic reconstructive surgery. Enhanced Recovery After Surgery (ERAS) pathways in gynecologic surgery have been associated with decreased postoperative pain, need for analgesia, complications, re-admissions, and length of hospital stay, with an emphasis on multimodal regimens and minimizing opioid administration. However, postoperative pain after urogynecologic surgery remains multifactorial and may be related to pelvic floor muscle spasm or dysfunction following surgery. Tizanidine, a skeletal muscle relaxant that acts centrally as an alpha-2 adrenergic agonist, has the unique ability to address pelvic floor muscle spasm and its contribution to postoperative pain, while having fewer adverse events in older patients compared to other skeletal muscle relaxants. Although one randomized control trial demonstrated favorable effects of tizanidine on postoperative pain and recovery after inguinal hernia repair, no previous studies have examined its role in postoperative recovery and pain control for gynecologic patients.
The study will be conducted as a prospective, longitudinal, non-blinded, two-arm randomized controlled trial comparing the postoperative experience and pain control of patients utilizing tizanidine to those who are not taking tizanidine. Eligible participants include English- or Spanish-speaking women aged 18-89 years undergoing apical suspension with concomitant vaginal repairs. Participants will be randomized in a 1:1 ratio to either a control arm receiving standard ERAS postoperative care or an intervention arm receiving standard ERAS care plus tizanidine 4 mg three times daily for two weeks postoperatively.
Data collection will include demographic, medical, surgical, and healthcare utilization information, as well as validated surveys administered preoperatively, on postoperative day 1-2, at 2 weeks, and at 4-6 weeks postoperatively. The primary outcome is patient-reported outcome (PRO) assessed at 4-6 weeks postoperatively. Secondary outcomes include pain and recovery measures, opioid use, constipation, and healthcare utilization including readmissions, ED visits, telephone encounters, patient portal messages, and additional pain medication prescriptions. The study aims to recruit 186 patients to achieve 150 completed participants. Findings may help investigate a postoperative pain regimen that could decrease opioid use and improve postoperative recovery in urogynecologic patients.
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
- None
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •female, age ≥18 and ≤89 years old
- •any race/ethnicity
- •English and/or Spanish fluency
- •undergoing apical suspension:
- •sacrocolpopexy (laparoscopic or robotic)
- •uterosacral ligament suspension (vaginal, laparoscopic, or robotic)
- •sacrospinous ligament fixation
- •iliococcygeus suspension
- •surgery being performed at Hartford Hospital
排除标准
- •age <18 or ≥90 years old
- •breastfeeding
- •documented diagnosis of hypotension in EMR problem list, BP in office or at pre-op PAC (confirmed on repeat) to be systolic <100 mm Hg and/or diastolic <70 mm Hg
- •known intolerance or sensitivity to tizanidine
- •current use of:
- •CYP1A2 inhibitor:
- •clonidine (alpha-2 agonist) antihypertensive
- •muscle relaxant
- •pre-existing
- •hepatic impairment as defined as transaminitis with ALT or AST >2x upper limit of normal
- •diagnoses of cirrhosis, alcoholic liver disease, non-alcoholic fatty liver disease (NAFLD)
- •renal impairment as defined by creatinine clearance <25 mL/min
- •obstructive sleep apnea
- •non-English or non-Spanish speaking
- •past opioid dependence
- •concurrent diagnosis of malignancy
- •concurrent surgery apart from pelvic reconstructive surgery with another specialty
- •unable/unwilling to consent to participate
研究组 & 干预措施
Control
Participants will follow standard-of-care -- the current standard ERAS protocol including preop medication management with Tylenol and Celebrex (unless contraindicated) and postoperative outpatient pain regimen of scheduled Tylenol, Motrin, and as-needed standard amounts of opioid medication. A placebo will not be used in this study.
干预措施: Standard-of-Care Therapy (Other)
Intervention/Tizanidine
Participants will follow standard-of-care -- the current standard ERAS protocol above -- and will be given tizanidine 4 mg scheduled three times a day (12 mg/day) for two weeks postoperatively.
干预措施: Tizanidine (Drug)
结局指标
主要结局
Patient Reported Outcome (PRO)
时间窗: 4-6 weeks post-operatively
Patient-reported outcome (PRO) assessed at 4-6 weeks post-operatively is the primary outcome. The PRO is a single question survey "To what extent do you feel physically recovered after surgery" that identifies a patient's perceived post-operative recovery with recent publication of content validity in urogynecology research. Answer choices are "I don't feel at all recovered," "I feel recovered up to 25%," "I feel recovered up to 50%," "I feel recovered up to 75%," and "I feel fully recovered."
次要结局
- Pain and Recovery-objective(4-6 weeks post-operatively)
- Pain and Recovery- subjective(4-6 weeks)
- Healthcare Utilization(6 weeks post-operative)
- Constipation(2 weeks post-operative)