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临床试验/NCT03789435
NCT03789435已完成不适用

Medium-term Incidence Study of Phantom Limb Syndrome in Trans Femoral and Trans Tibial Amputated Patients

Istituto Ortopedico Rizzoli1 个研究点 分布在 1 个国家目标入组 73 人开始时间: 2019年3月7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
73
试验地点
1
主要终点
Mid-term incidence (1 to 3 years) of pain in the stump or phantom limb and phantom limb sensation in amputated trans femoral and trans tibial patients treated at IOR from 2015 to 2017.

研究概览

简要总结

Phantom limb is difficult to manage and has a significant impact on the patient's quality of life. At present, the scientific evidence shows that the infusion of local anesthetics with epidural and perineural catheters in the perioperative phase correlates with good pain control in the immediate post-operative, expressed in terms of reduced demand for opiates by the patient undergoing amputation. of lower limb. Few are studies that highlight the effectiveness of such treatments in the medium and long-term prevention of phantom limb syndrome.

The study aims to evaluate the incidence in the medium term of the phantom limb in trans femoral and trans tibial amputees and the possible relationship with the use of adequate pre and perioperative analgesia using peridural and peripheral nerve catheters. The results of the study could provide indications about the need to modify both the perioperative analgesic therapy protocol and also rehabilitation for lower limb amputation surgery in order to reduce the prevalence of phantom limb syndrome with consequent improvement in quality of life.

详细描述

The prevalence of phantom limb varies from 50-90% in amputated patients. When present, it is difficult to manage and has a significant impact on the patient's quality of life. The causes that determine the development and above all the persistence of this remote syndrome are not known, however some studies report the importance of psychological factors, also related to the time of use of the prosthesis.

After an amputation it is possible to have different pictures of residual pain that are classified as:

  • Stump pain (residual limb pain -RLP): described as burning, shock, cut, hypersensitivity of the stump (post-surgical nociceptive, neurogenic, protesigenic, arthrogenic, ischemic, sympathetic, from adhesive scar tissue or hetero topical ossifications, has a incidence of 74% and may persist up to 14 years after amputation.
  • Phantom limb pain (PLP) pain: described as a similar neuropathic (cutting, traction, shock pain) and as a similar nociceptive (deaf, cramp-like, compressive), is present in the first 6 months after amputation, but can last for years, and affects up to 85% of patients.
  • Phantom limb sensations (phantom sensations - PSs): non-painful perceptions from the part of the body lost after deafferentation or amputation (kinetic, kinesthetic and exteroceptive), is common in the postoperative period, in one third of patients within 24 hours , in three quarters of patients within 4 days, and in 90% of patients, persist within 6 months of surgery.

At present, the scientific evidence shows that the infusion of local anesthetics with perioperative epidural and perineural catheters correlates with good pain control in the immediate post-operative period expressed in terms of reduced opiate demand by of the patient undergoing limb amputation. However, there are no studies on the medium to long-term incidence of phantom limb syndrome in patients who have been treated with multimodal analgesic protocols. Only the observational study performed by Borghi et al. showed that a 3% incidence of phantom limb syndrome in patients treated with prolonged infusion for an average of 30 days with a 0.5% ropivacaine perineural catheter was shown 12 months after limb amputation surgery. Based on this experience for years at the Rizzoli Orthopedic Institute, peridural and peripheral catheters are applied with a dedicated protocol. At present, however, there is no further assessment of the incidence of phantom limb in patients amputated to the IOR who have followed the protocols in use.

Aim The study aims to evaluate the incidence of phantom pain in the medium term, the sensation of phantom limb and the pain of the stump in amputated trans femoral and trans tibial patients operated on the IOR who followed the perioperative analgesic protocol with use of catheters peridural and peripheral nerves. The results of the study could provide indications about the need to modify the perioperative and rehabilitative analgesic therapy protocol for lower limb amputation surgery to favor a reduction in the intensity, prevalence and frequency of phantom limb syndrome with consequent improvement in the quality of life.

研究设计

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

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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Mid-term incidence (1 to 3 years) of pain in the stump or phantom limb and phantom limb sensation in amputated trans femoral and trans tibial patients treated at IOR from 2015 to 2017.

时间窗: 7 days

Data will be obtained by means of questionnaire sent to patients.

Evaluation of the type of anesthesia and perioperative analgesic treatment with peripheral nerve block effected and of the use of the prosthesis to evaluate possible relations with the presence and the entity of the phantom limb.

时间窗: 7 days

Anesthesia data will be retrieved from patient records.

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

Mariagrazia Benedetti

Head Physical Medicine and Rehabilitation Unit

Istituto Ortopedico Rizzoli

研究点 (1)

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