Effectiveness of Fascia Iliaca Nerve Block for Post Hip Arthroscopy Pain Management: A Randomized Double-blind, Placebo Controlled Study
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- The investigators will measure morphine consumption as the endpoint, to compare the efficacy of each group
研究概览
简要总结
There is currently no standard of care or best practice for managing post-operative pain for patients undergoing hip arthroscopy. Perioperative pain with these procedures can be substantial. It has been shown that up to 90% of patients in the Post-anesthesia care unit (PACU) following hip arthroscopy report pain scores of 7/10. Poor pain management following hip fracture surgery directly results in increased time spent in high cost health care areas and delayed time to ambulation. Continuous regional anesthesia following hip arthroplasty has been shown to reduce narcotic consumption and related side-effects (reduction of post-operative pain, delirium, and length of stay).
The purpose of this research is to evaluate the effectiveness of a fascia iliaca nerve block in reducing post-operative pain within the first 24 hours following hip arthroscopy. Additionally, the pharmacokinetics of the drug ropivacaine will be studied via laboratory analysis of blood samples. Ultimately, the objective of this research is to develop a standard of care or best practice for the management of post-operative pain following hip arthroscopy. This study will include the entire age range of patients who are seen for hip arthroscopy at Boston Children's Hospital, for which there is a 35 year age limit. Both sexes will be included in the study.
The study design will be real catheter versus a sham catheter(control). All subjects will receive general anesthesia. The catheters (real or sham) will be administered after the induction of general anesthesia and before the beginning of the surgery until 24 hours after recorded PACU admittance time. The anesthesia team placing the block will not be blinded. The orthopaedic surgeon (Dr. Yen) and all evaluators will be blinded to the absence or presence of a real catheter. In the case of a sham catheter, the anesthesia team will rig a pump to look like it is dispensing local anesthesia.
To determine the pharmacokinetics of ropivicaine during standard fascia iliaca block, following induction of general anesthesia, a large bore IV catheter will be inserted for the purpose of blood draws (all patients).
详细描述
This study will be a randomized, double-blinded, placebo controlled study. All patients who are scheduled to undergo a hip arthroscopy with Dr. Yen who meet the inclusion/exclusion criteria will be approached and informed consent and assent when indicated would be obtained.Attending surgeon, anesthesia care team, PACU nursing staff, inpatient ward nursing staff and evaluators will be blinded to study group. Regional Anesthesia team and pharmacy staff will be not blinded to assignment of patient group but will have no additional contact with patient after provision of sham or actual perineural catheter. the study design will be real catheter versus a sham catheter, or control. All subjects will receive general anesthesia. The catheters (real or sham) will be administered after the induction of general anesthesia and before the beginning of the surgery until 24 hours after recorded PACU admittance time. The anesthesia team placing the block will not be blinded. The orthopaedic surgeon (Dr. Yen) and all evaluators will be blinded to the absence or presence of a real catheter. In the case of a sham catheter, the anesthesia team will rig a pump to look like it is dispensing local anesthesia.
- General Anesthesia a) Induction (IV): i. propofol: 2-4 mg/kg [9] ii. fentanyl: 2 mcg/kg administered iii. decadron: 4 mg as an antiemetic b) Airway: i. Airway management will be chosen by the anesthesiologist in charge of the case.
c) Maintenance of anesthesia i. Sevoflurane 1.1 minimum alveolar concentration (MAC) ii. If heart rate or blood pressure increase > 20% above baseline (tachycardia as determined the morning of surgery in the holding area), anesthesiologist will administer1 microgram/kg fentanyl as bolus. May repeat as often as every 10 minutes. Maximum 8 doses.
iii. With patient movement, anesthesiologist will administer propofol 1 mg/kg intravenous push. May repeat every 5 minutes as necessary.
d) Emergence i. Discontinue isoflurane ii. Zofran 4 mg IV iii. Ketorolac 0.5 mg/kg IV; max dose 30 mg. 2. Perineural Catheter:
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient age at surgery is 12-
- •Able to provide informed consent and/or assent.
- •Diagnosis is Femoro-acetabular impingement (FAI) and/or labral tear.
- •Surgery will involve and be limited to hip arthroscopy and osteoplasty of the acetabular rim or femoral head/neck junction.
- •Surgery will be performed by Dr. Yi-Meng Yen.
- •Admission status: 24 hour admission to hospital.
- •No contraindication to study procedures
排除标准
- •Hip revision surgery
- •Underlying neurologic disorder affecting pain perception.
- •Underlying neurocognitive disorder or developmental delay affecting ability to convey feelings of pain to medical staff.
- •Underlying opioid use or addiction.
- •Significant concomitant hip pathology.
- •Active infection over catheter site.
- •History of chronic pain (not localized to the hip) requiring consistent opioid consumption for greater than or equal to 6 months within year prior to surgery.
- •Allergy to local anesthetics
- •Allergy to fentanyl
- •Allergy to midazolam
- •Allergy to morphine
- •American Society of Anesthesia class 3 or higher.
结局指标
主要结局
The investigators will measure morphine consumption as the endpoint, to compare the efficacy of each group
时间窗: Within the first 24hs after the fascia iliaca block is placed.
次要结局
- The investigators will collect postoperative pain scores using the 11 point numeric rating scale in each group, to compare the efficacy of each group(Within the first 24hs after the fascia iliaca block is placed.)
- The investigators will collect time to first opioid consumption in each group, To compare the efficacy of each group.(Within the first 24hs after the fascia iliaca block is placed.)
- The investigators will document incidence of postoperative nausea and vomiting in each group.(Within the first 24hs after the fascia iliaca block is placed.)
- The investigators will measure maximum plasma concentrations at specific time intervals of 0.2% ropivacaine administered via a fascia iliaca block.(Within the first hour after the fascia iliaca block is placed.)
研究者
Karen Boretsky
Dr. Karen Boretsky
Boston Children's Hospital