跳至主要内容
临床试验/NCT04541745
NCT04541745已完成不适用

Prospective Cohort Study Comparing Functional Recovery Following Orthopedic Wrist Surgery Under Peripheral Nerve Block Versus General Anesthesia

Université de Sherbrooke1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2019年8月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
72
试验地点
1
主要终点
Functional recovery using the range of motion of all movement of the wrist

研究概览

简要总结

This study aims at determining if there is an association between locoregional anesthesia and postoperative functional recovery for orthopedic surgery to repair a distal radial fracture, as compared to general anesthesia.

详细描述

All patients undergoing orthopedic wrist surgery under locoregional or general anesthesia at the CIUSSS de l'Estrie-CHUS who meet the selection criteria will be approach to participate in this prospective single-center observational study. Using the visual analog scale and anesthesia scale, the pain and the satisfaction of the patient will be evaluated respectively 2 weeks postoperatively. At the second visit, 6 to 8 weeks postoperatively, the participant will complete the QuickDASH questionnaire to evaluate his functional recovery and the participant's pain will be reassessed with the visual analogue scale. Finally, 12 weeks postoperatively, the wrist-joint range of motion and grip-strength test results will be recorded. The participant will also be asked to complete the QuickDASH and PRWE (Patient-Rated Wrist Evaluation) questionnaires to reevaluate his functional recovery.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • 18 years old and more
  • American Society of Anesthesiologists (ASA) score I, II, or III
  • Single distal radial fracture with or without ulna involvement
  • Orthopedic surgery by open reduction of the wrist for a distal radial fracture with or without ulnar involvement

排除标准

  • Active pregnancy
  • Surgery with combined anesthesia (locoregional and general)
  • Locoregional anesthesia with catheter insertion for postoperative analgesia
  • Individuals with chronic pain as defined by preexisting neuropathy of the operated arm, preexisting radiculopathy of the operated limb, complex regional pain syndrome, or fibromyalgia
  • Polytrauma
  • Inability to consent

结局指标

主要结局

Functional recovery using the range of motion of all movement of the wrist

时间窗: 12 weeks post-surgery

We evaluate the range of motion of all movement of the wrist with a goniometer

Functional recovery using the QuickDASH (Quick Disabilities of Arm, Shoulder and Hand) questionnaire

时间窗: 12 weeks post-surgery

The QuickDASH assess the functional recovery. It consists of 11 questions scored from 1 to 5 (1 = no difficulty to 5 = unable). Higher scores indicate a greater level of disability.

Functional recovery using the PRWE (Patient Rated Wrist Evaluation) Questionnaire

时间窗: 12 weeks post-surgery

The PRWE (Patient Rated Wrist Evaluation) Questionnaire assess the pain and the persistence of functional difficulty in activities of daily living following wrist surgery. It consists of 15 questions, each rated on a scale from 0 to 10. Five questions deal specifically with pain and are rated as 0 (no pain) to 10 (worse pain); 10 questions are on functional recovery, rated from 0 (no difficulty) to 10 (unable to do). Higher scores on the subscales represent greater pain or functional disability.

Functional recovery using the grip strenght

时间窗: 12 weeks post-surgery

We evaluate the grip strength with JAMAR hydraulic hand dynamometer. The participant squeezes the device as hard as they can. We averaged three values on both sides.

次要结局

  • Functional recovery at 6 weeks(6 weeks post-operative)
  • Pain - 6 weeks(6 weeks post-operative)
  • Pain- 2 weeks(2 weeks post-operative)
  • Patient satisfaction(2 weeks post-operative)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jennifer Héroux

Anesthesiology and CIP resident

Université de Sherbrooke

研究点 (1)

Loading locations...

相似试验