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临床试验/NCT03396991
NCT03396991已完成不适用

Comparative Evaluation of Two Different Post-Operative Analgesia After Hallux Valgus Correction in One-day Surgery Patients

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2017年7月1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
26
试验地点
1
主要终点
Pain control measured by a visual analogue scale of Scott-Huskisson (VAS score)

研究概览

简要总结

Background: Recent studies showed the efficiency of several techniques of anesthesia in foot surgery. The new mini-invasive surgical approaches should require less analgesia and rapid motor recovery after surgery. The aim of this study was the evaluation of two different techniques on postoperative analgesia and motor recovery after hallux valgus correction in one-day surgery patients.

详细描述

The hallux valgus surgery is often characterized by a significant post-operative pain difficult to control with oral analgesics. Consequently, large doses of parenteral opioids are often required Various nerve blocks (popliteal, saphenous, sciatic) can give excellent post-operative pain control. Among loco-regional anesthesia techniques, the sciatic nerve block provides good post-operative pain relief after foot surgery. Thus, sciatic nerve block with long-acting local anesthetics (with or without a peri-neural catheter) has been recommended as a primary option. This analgesic approach should cause a difficult discharge in ambulatory and one-day surgery patients, due to the prolonged motor recovery and loss of proprioception and protective pain reflexes. Therefore, it would be preferable to use the sciatic nerve block just for intra- operative anesthesia without affecting motor recovery, and to apply multimodal analgesia for post- operative pain management. Hallux valgus repair can now be done percutaneously, a minimally invasive technique called ''mini-invasive hallux valgus repair'', consisting in osteotomies through 3 to 5 mm incisions, without internal fixation. This approach requires less dissection and exposure, determining a smaller inflammatory response and theoretically causing less pain. Ideal anesthesia for these procedures should provide rapid patient recovery, minimal nursing care requirements in the post- anesthesia care unit and an earlier hospital discharge. It must provide effective analgesia, since the foot surgery is known to induce a moderate-to- severe post-operative pain, that represents one of the major limitations to hospital discharge on the day of surgery and is the main cause of re-admission.

The aim of this matched-control study was to evaluate two different techniques of post-operative analgesia after hallux valgus correction in one-day surgery patients.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

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

  • hallux valgus deformity
  • walking difficulty with shoes

排除标准

  • peripheral circulatory disorders
  • foot skin lesion
  • local anesthetic allergy

结局指标

主要结局

Pain control measured by a visual analogue scale of Scott-Huskisson (VAS score)

时间窗: One month

Pain control measured by a visual analogue scale of Scott-Huskisson (VAS, 0 lack of pain, 10 the worst pain).

次要结局

未报告次要终点

研究者

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

FERRONE GIULIANO

Medical Doctor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

研究点 (1)

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