跳至主要内容
临床试验/NCT06863688
NCT06863688Enrolling By Invitation不适用

Does Tourniquet Utilization Negatively Impact Patient Pain and Outcomes Following Operative Fixation of Rotational Ankle Fractures? A Randomized Clinical Trial.

Alex Demers1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年11月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
100
试验地点
1
主要终点
Patient-Reported Outcome Measurement Information System (PROMIS) Cat V1.1 Pain Interference scores

研究概览

简要总结

Lower extremity tourniquet utilization remains a controversial practice during the operative fixation of rotational ankle fractures and is often left to surgeon discretion. At our own institution, tourniquet use varies between surgeons with some providers using a tourniquet for every case, while others regularly do not utilize tourniquets. Despite benefits of decreased surgical time and decreased blood loss, many studies have cited negative outcomes associated with tourniquet usage including increased postoperative swelling and pain, increased wound complications, and increased risks of deep vein thrombosis. These outcomes have been limited to retrospective reviews and meta-analyses with few randomized control trials specifically evaluating these outcomes in ankle fracture patients. To better assess the impact of tourniquet use on ankle fracture postoperative outcomes, this randomized control trial seeks to 1) compare differences in postoperative visual analog scale pain scores for patients undergoing operative fixation of rotation ankle fractures with and without a tourniquet, while 2) evaluating rates of wound, thrombotic, and surgical complications associated with tourniquet use. Patients will be randomized by an Excel random number generator to a tourniquet and non-tourniquet group. Patients will remain blinded to randomization. The treating orthopaedic trauma surgeon will be notified by the PI of the study informing them of the randomization status to ensure appropriate tourniquet utilization the day of surgery. Patients will then undergo standard operative fixation and postoperative management as clinically indicated by the orthopaedic trauma team. Patients will follow-up at 2 weeks and subsequently every 4 weeks as is protocol at our institution. Patient charts will be reviewed for patient and perioperative factors, as well as postoperative complications (i.e. wound complications, need for repeat surgical intervention, and deep vein thrombosis).

详细描述

Lower extremity tourniquet utilization remains a controversial practice during the operative fixation of rotational ankle fractures and is often left to surgeon discretion. At our own institution, tourniquet use varies between surgeons with some providers using a tourniquet for every case, while others regularly do not utilize tourniquets. Despite benefits of decreased surgical time and decreased blood loss, many studies have cited negative outcomes associated with tourniquet usage including increased postoperative swelling and pain, increased wound complications, and increased risks of deep vein thrombosis. These outcomes have been limited to retrospective reviews and meta-analyses with few randomized control trials specifically evaluating these outcomes in ankle fracture patients. To better assess the impact of tourniquet use on ankle fracture postoperative outcomes, this randomized control trial seeks to 1) compare differences in postoperative visual analog scale pain scores for patients undergoing operative fixation of rotation ankle fractures with and without a tourniquet, while 2) evaluating rates of wound, thrombotic, and surgical complications associated with tourniquet use. II.

Tourniquet utilization in the operative fixation of ankle fractures remains controversial and is often subject to surgeon preferences. Despite postulated benefits of minimizing blood loss, decreasing operative times, and improving visualization, tourniquets in ankle fracture fixation have been associated with increased postoperative pain, swelling, decreased range of motion, and increased opioid consumption. Previous literature has demonstrated a nonsignificant increase in wound infections and deep vein thrombosis (DVT) with tourniquet usage. Changes in perfusion intraoperatively and effects of ischemic reperfusion injury have been theorized as drivers of these negative side effects of tourniquets. Perfusion following ankle fracture fixation, thus represents an opportunity to better understand the physiologic implications of tourniquet utilization.

Tourniquet use is associated with negative outcomes after total knee arthroplasty (TKA). Despite decreased blood loss, tourniquet use in TKA has been associated with higher VAS pain scores, decreased knee range of motion and functional scores in the early postoperative period, higher rates of thrombotic events, infection, and reoperation. Impaired prosthesis survival, knee function, blood transfusion rates, quality of life, and patient satisfaction bring into question the utility of tourniquet use in TKA. These outcomes have not been thoroughly investigated in the fixation of ankle fractures.

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)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients >18 y.o. undergoing ankle fracture open reduction internal fixation
  • Ground level fall as mechanism of injury
  • Closed injury

排除标准

  • Open Ankle Fractures
  • Vascular Injury Requiring Intervention
  • Lower extremity injuries on same side of ankle fracture
  • e) Active anticoagulation/bleeding disorder necessitating tourniquet use (Hemoglobin <7, PT >13, PTT>35) f) Ipsilateral lower extremity trauma impacting immobilization g) Patients with peripheral neuropathy h) Patients undergoing ankle arthroscopy

研究组 & 干预措施

Tourniquet Group

Experimental

Patients randomized to this group will have a tourniquet used during the operative fixation of their ankle fracture. Tourniquets will be inflated to 250 mmHg as is standard for our institution. Tourniquet will be deflated at time of closure.

干预措施: Tourniquet (Device)

No Tourniquet Group

Other

Patients randomized to this group will not have a tourniquet used during operative fixation of their ankle fracture. A tourniquet will be placed on the patient's operative extremity as a safety precaution, but will remain deflated for the duration of the procedure unless emergently needed for hemostasis.

干预措施: No Tourniquet (Other)

结局指标

主要结局

Patient-Reported Outcome Measurement Information System (PROMIS) Cat V1.1 Pain Interference scores

时间窗: 6 weeks, 3 months

Patient-Reported Outcome Measurement Information System (PROMIS) scores including PROMIS Cat V1.1 Pain Interference (10-90, lower is better) will be completed at 6 week and 3 month follow-up appointments as part of standard clinic workflow.

Patient-Reported Outcome Measurement Information System (PROMIS) Cat V2.0 Physical Function Score

时间窗: 6 weeks, 3 month

Patient-Reported Outcome Measurement Information System (PROMIS) scores including PROMIS Cat V2.0 Physical Function (10-90, higher is better) will be completed at 6 week and 3 month follow-up appointments as part of standard clinic workflow.

Patient-Reported Outcome Measurement Information System (PROMIS) Scale V1.2 Global Health Score

时间窗: 6 weeks, 3 months

Patient-Reported Outcome Measurement Information System (PROMIS) scores including PROMIS Scale V1.2 Global Health (15-70, higher is better) will be completed at 6 week and 3 month follow-up appointments as part of standard clinic workflow.

Visual Analog Scale Pain Levels

时间窗: Post anesthesia recovery unit, 2 weeks postoperatively, 6 weeks, 3 month follow-up

VAS pain scores (0-10) will be assessed for the ankle immediately postoperatively in the post anesthesia care unit and at 2 weeks, 6 weeks and 3 months postoperatively.

Optimal Screening for Prediction of Referral and Outcome (OSPRO) Yellow Flag 17-Item

时间窗: 6 weeks, 3 months

OSPRO-Yf 17 questionnaires will be completed at follow-up appointments as part of standard trauma clinic workflow and will be assessed at 6 weeks, and 3 months.

次要结局

  • Postoperative Complications(6 months)

研究者

发起方
Alex Demers
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Alex Demers

Resident Physician

University of Iowa

研究点 (1)

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