Ultrasound-guided Fascia Iliaca Compartment Block Versus Periarticular Infiltration for Pain Management After Total Hip Arthroplasty: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Postoperative Pain Score With Movement
研究概览
简要总结
This randomized, controlled, observer-blinded study clinical trial was designed to evaluate ultrasound-guided fascia iliaca compartment block with ropivacaine and periarticular infiltration with ropivacaine for postoperative pain management after total hip arthroplasty.
详细描述
Despite substantial advances in our understanding of the pathophysiology of pain and availability of newer analgesic techniques, postoperative pain is not always effectively treated. Optimal pain management technique balances pain relief with concerns about safety and adverse effects associated with analgesic techniques. Currently, postoperative pain is commonly treated with systemic opioids, which are associated with numerous adverse effects including nausea and vomiting, dizziness, drowsiness, pruritus, urinary retention, and respiratory depression. Use of regional and local anesthesia has been shown to reduce opioid requirements and opioid-related side effects.
Patients undergoing total hip arthroplasty (THA) (n=60) at Parkland and UT Southwestern Medical Center Hospitals will be randomized into one of two groups to receive either ultrasound-guided fascia iliaca compartment block (FICB) with ropivacaine 300 mg and 0.5 mg epinephrine (Group 1) or periarticular infiltration ropivacaine 300 mg and 0.5 mg epinephrine total (Group 2) for postoperative pain management. The remaining aspect of perioperative care, including the anesthetic technique (i.e., spinal anesthetic), pre- and postoperative care will be standardized and will be similar for all patients. The duration of the involvement in the study will be until 48 hours postoperatively.
Patients in Group 1 will receive ultrasound-guided FICB after surgery. Patients in Group 2 will receive ropivacaine via periarticular infiltration prior to closing the incision.
The postoperative analgesia will be documented using the visual analog score (0=no pain, 10=worst pain). In addition, total opioid dose over the 48-h study period will be documented. Postoperative nausea will be measured using a categorical scoring system (none=0, mild=1, moderate=2, severe=3) and episodes of vomiting will be documented. Rescue antiemetics will be given to any patient who complains of nausea and/or vomiting. All variables will be assessed at 2, 6, 12, 24, and 48 hours, postoperatively by an investigator blinded to group allocation.
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
- Single (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
- •Female ASA physical status 1-3 scheduled for total hip arthroplasty
- •Age 18-80 years old
- •Able to participate personally or by legal representative in informed consent in English or Spanish
排除标准
- •History of relevant drug allergy
- •Age less than 18 or greater than 80 years
- •Chronic opioid use or drug abuse
- •Significant psychiatric disturbance
- •Inability to understand the study protocol
- •Refusal to provide written consent
研究组 & 干预措施
Compartment Block
Fascia iliaca compartment block (FICB) with ropivacaine and epinephrine after surgery
干预措施: Ropivacaine (Drug)
Compartment Block
Fascia iliaca compartment block (FICB) with ropivacaine and epinephrine after surgery
干预措施: Epinephrine (Drug)
Infiltration
Periarticular infiltration with ropivacaine and epinephrine prior to closing the incision
干预措施: Ropivacaine (Drug)
Infiltration
Periarticular infiltration with ropivacaine and epinephrine prior to closing the incision
干预措施: Epinephrine (Drug)
结局指标
主要结局
Postoperative Pain Score With Movement
时间窗: Postoperative 48 hours
The Visual Analog Pain Score (VAS) with movement on the scale of 10 (0= No pain, 10= Worst pain) at 48 hours postoperatively
Postoperative Pain Score at Resting
时间窗: Postoperative 48 hours
The Visual Analog Pain Score (VAS) at resting on the scale of 10 (0= No pain, 10= Worst pain) at 48 hours postoperatively
次要结局
- Oral Morphine Equivalents of Postoperative Opioid Requirements for 48 Hours(Postoperative 48 hours)
- The Time to Ambulation(Postoperative 48 hours)
研究者
Irina Gasanova
Associate Professor
University of Texas Southwestern Medical Center
