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Pain in Trans Femoral and Trans Tibial Amputees

NCT03789435 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 73

Last updated 2020-01-13

No results posted yet for this study

Summary

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.

Conditions

  • Lower Limb Amputation Above Knee
  • Lower Limb Amputation Below Knee

Interventions

DIAGNOSTIC_TEST

Questionnaire

A questionnaire from which the session dedicated to the evaluation of the stump pain, the phantom limb and the sensation of the phantom limb has been extracted will be administered: this is the Prosthetic Evaluation Questionnaire (PEQ) validated in Italian by Ferrero et al. 2005. In the questionnaire sent to patients will be asked also for anthropometric data (weight, height) in addition to the characteristics of the worn prosthesis and if they have followed a period of rehabilitation.The time of use of the prosthesis will be evaluated through the Houghton Scale of Prosthetic Use in People with Lower- Extremity Amputations (19)

Sponsors & Collaborators

  • I.R.C.C.S. Fondazione Santa Lucia

    collaborator OTHER

  • Istituto Ortopedico Rizzoli

    lead OTHER

Principal Investigators

  • Maria Grazia Benedetti · IRCCS-Istituto Ortopedico Rizzoli

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-07
Primary Completion
2019-08-31
Completion
2019-09-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03789435 on ClinicalTrials.gov