Peri-incisional Local Infiltration to Improve Pain Control After Periacetabular Osteotomy
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Post-operative pain after periacetabular osteotomy.
研究概览
简要总结
The goal of this clinical trial is to compare different peri-incisional local infiltrative anesthesia (PLIA) methods in patients ages 13 to 50 undergoing a periacetabular osteotomy (PAO). The main questions to answer here are:
- Does PLIA impact post-operative pain after PAO?
- Does PLIA impact pain medication usage as measured by morphine equivalent dosing (MED) after PAO?
- Does the timing of PLIA administration impact post-operative pain and MED after PAO? Participants will be asked to complete some surveys; demographics survey, General Self-Efficacy Scale (GSE) and the Pain Resilience Scale. All other information will be gathered from the patients medical chart.
Researchers will compare three groups. 1.) Patients who do not receive PLIA. 2.) Patients who receive PLIA after their incision is closed. 3.) Patients who receive PLIA throughout PAO.
详细描述
Patients will be approached at their preoperative appointment. This is the only time researchers will conduct study related activities with patients. All other information will be gathered by chart review. Following consent, patients will be asked to complete surveys through REDCap® using a tablet or computer. These include a self-efficacy survey and a grit survey. Patients will then be randomized in a 1:1:1 ratio. 1.) Patients who do not receive PLIA. 2.) Patients who receive PLIA after their incision is closed. 3.) Patients who receive PLIA throughout PAO.
Patients will be blinded to which group they are in, meaning they will not know whether they received the injection or not. Patients may ask to be told what study group they were in at their standard-of-care, 3 month follow-up visit.
Following surgery, patients in all treatment arms will be provided with the same intravenous (patient-controlled analgesia) and oral pain medications scheduled as needed per standard of care.
The research team will review patient medical records to record narcotic use and visual analog scale (VAS) pain scores post-operatively until discharge from the hospital.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 13 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adolescent or young adult diagnosed with hip dysplasia indicated for PAO at University of Iowa Hospital and Clinics.
排除标准
- •Unable to provide informed consent.
- •Pregnant or breast-feeding individuals
- •Prisoner or ward of the state
- •Allergy or medical contradiction to any of the study medications
- •Patients undergoing femoral osteotomy or surgical hip dislocation with PAO will be excluded
研究组 & 干预措施
Control
No medication administration. Standard of care medications will be offered.
Post Closure
Once the fascia has been closed, the PLIA will be administered using a pediatric catheter.
干预措施: Ropivacaine, Epinephrine, Ketorolac, NaCl (Saline) (Combination Product)
Throughout Procedure
The injection will be performed throughout the surgical procedure.
干预措施: Ropivacaine, Epinephrine, Ketorolac, NaCl (Saline) (Combination Product)
结局指标
主要结局
Post-operative pain after periacetabular osteotomy.
时间窗: Post Anesthesia Care Unit (PACU), 24 hours post op
Severity of pain will be measured by collection of the visual analog scale (VAS) for pain. Scale of 1-10.
Pain medication usage after periacetabular osteotomy.
时间窗: Post Anesthesia Care Unit (PACU) to end of hospital stay, an average of 3 days.
The amount of pain medications taken will be measured using morphine equivalent dosing (MED).
The impact of timing of PLIA administration on post-operative pain.
时间窗: Post Anesthesia Care Unit (PACU) to end of hospital stay, an average of 3 days.
The mean VAS pain will be compared between the different study groups. Scale of 1-10.
The impact of timing of PLIA administration on MED.
时间窗: Post Anesthesia Care Unit (PACU) to end of hospital stay, an average of 3 days.
The mean MED will be compared between the different study groups.
次要结局
- Assessment on depression (PHQ-9)(Preoperative)
- General Self-Efficacy Scale (GSE)(Preoperative)
- Pain Resilience Scale.(Preoperative)
研究者
Michael C Willey
Assistant Professor of Orthopedics and Rehabilitation
University of Iowa