Prospective Evaluation of Post-operative Pain Management Using Peripheral Nerve Blocks in the Pediatric Population
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Visual Analog Scale (VAS) Wong-Baker Face Pain Scale
研究概览
简要总结
The goal of this randomized clinical trial is to determine if single-shot ropivacaine peripheral nerve blocks (PNB - perineural injections) for anterior cruciate ligament (ACL) reconstruction procedures in pediatric orthopaedic sports medicine patients provides significant pain relief and decreased narcotic use. The main questions it aims to answer are:
- Does ropivacaine significantly reduce Visual Analog Scale (VAS) pain scores and pain levels up to one week postoperatively?
- Does ropivacaine significantly decrease narcotic use (number of pills taken) up to one week postoperatively?
Researchers will compare the pain outcomes and narcotic use of participants who receive a single-shot ropivacaine peripheral nerve block to those of participants who do not receive a single-shot ropivacaine peripheral nerve block for their ACL reconstruction surgery. The goal is to understand if there is a significant difference in participant pain outcomes and narcotic use outside the first 24 hours postoperatively.
Participants will:
- receive either a single-shot ropivacaine peripheral nerve block intraoperatively or no peripheral nerve block during their ACL Quadriceps tendon graft or bone patellar tendon bone graft reconstruction surgery.
- receive and complete questionnaires at postoperative days 1, 4, and 7 regarding their pain scores, levels, and outcomes, effective pain treatments, overall pain interference, narcotic use (number of pills taken), and overall pain treatment satisfaction
- receive and complete secondary outcome measures of functional and psychological outcomes regarding their ACL reconstruction surgery at postoperative day 1
详细描述
This is a single institution, prospective, single-blinded (patient) randomized controlled trial to investigate the safety and pain-control efficacy and patient reported pain outcomes of PNBs in youth receiving ACLR. To be included, participants must be aged 13+ years at the time of surgery and present with an injury requiring an isolated ACL reconstruction with either a Bone-Patellar Tendon-Bone or Quadriceps tendon graft. Data will be collected from the patient's electronic medical record and from Oberd. Data collected will include age, height, weight, surgical information, diagnosis, and patient demographics. 160 participants (80 per treatment group) will be enrolled in the study with a minimum of 130 needed to complete the study.
As ACLR procedures are a frequent and standardized procedure at this institution, choosing to exclusively study this population offers a homogenous and plentiful sample. Pain protocols will follow a standard outline used by all participating surgeons to reduce variability between patients. The randomization technique of this study is supported by the equipoise of this institution's physicians regarding peripheral nerve blocks and the quantity of patients who this study's results will affect.
Patients will be approached pre-operatively for participation, after which the surgical team will be informed. Patients will be offered the choice to participate in the study and randomize their treatment group. If patients do not want their treatment to be randomized, they will not be included in the study. Data collection will involve the Wong-Baker Visual Analog Scale (VAS) and VAS 10-centimeter line 0-10 Numeric Pain Intensity Scale, and an institution specific pain questionnaire regarding analgesic medicine intake and complications daily from post-operative day one to post-operative day seven. Patients' medical records will also be reviewed for readmission, calls to their physician for pain, and other noted complications.
Patients will receive the following anesthesia doses by body weight (BW):
Pre-operatively:
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 (Participant)
盲法说明
Patients will be randomized after consent is obtained and will not know if they receive a single-shot peripheral nerve block. Due to current standard of care procedures, all patients will consent to receiving a peripheral nerve block despite their randomized group.
入排标准
- 年龄范围
- 13 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be aged 13+ years at time of surgery
- •Must present with injury requiring an ACLR procedure with a Bone Patellar Tendon Bone or Quadriceps graft
- •Ability to provide assent, legally appointed representative available to provide informed consent
排除标准
- •Patient <13 years old
- •Requires fracture repair or another non-standardized surgery
- •Any ACLR that requires the use of a graft type other than Bone Patellar Tendon Bone or Quadriceps tendon
- •Any lower extremity procedure that is not primarily an ACLR
- •Patient pregnancy
- •Inability to provide assent or legally appointed representative to provide informed consent
- •Prior history of hypersensitivity to Ropivacaine or any local anesthesia
研究组 & 干预措施
Peripheral Nerve Block (PNB) group
- A 20 mL Adductor PNB will be injected where determined as best place by anesthesiologist
- Patient will receive 0.2% plain Ropivacaine (perineural injection) regardless of weight
- Patient will be given a purple surgical marker dot at/near the site of injection by the anesthesiologist
干预措施: Ropivacaine 0.2% Injectable Solution (Drug)
结局指标
主要结局
Visual Analog Scale (VAS) Wong-Baker Face Pain Scale
时间窗: Postoperative days 1, 4, and 7
Scale with evocative faces from 0-10 (0 = No Pain, 10 = Worst Pain Possible) that assists children in communicating about their pain
Scottish Rite for Children-developed pain questionnaire
时间窗: Postoperative days 1, 4, and 7
Institutional questionnaire that asks how many narcotic pills the patient has taken (0 - 12 pills), if their pain is controlled, treatments that lessens their pain, term that best describes their pain, how much their pain has interfered with daily tasks and overall mood, and sleep interference due to pain.
Visual Analog Scale (VAS) 10-centimeter line 0-10 Numeric Pain Intensity Scale
时间窗: Postoperative days 1, 4, and 7
Sliding scale from 0-10 (0 = No Pain, 10 = Pain as bad as it could possibly be) that enables a more accurate estimate of pain score
Pain Management Patient Satisfaction questionnaire
时间窗: Postoperative day 7
Questionnaire that asks how satisfied patients are with their pain treatment (0 = Not Satisfied, 10 = Extremely Satisfied), if they contacted their physician due to ineffective pain treatment, how helpful the information provided for pain treatment was (0 = Not Helpful, 10 = Extremely Helpful), and a free response section to explain why they were not satisfied with their pain treatment and if they have any additional comments or suggestions based on their pain treatment.
次要结局
- Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Scale v1.0 - Global Health 7+2(Preoperatively and within one week postoperatively.)