Pain in Trans Femoral and Trans Tibial Amputees

NCT03789435 | Completed

• 1 other identifier: 0013569
• Study Type: observational
• Target: 73
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• 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.

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

  7 days

• 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.

  Anesthesia data will be retrieved from patient records.

  7 days

Study Arms (1)

Amputees

Patients underwent trans-tibial and trans-femoral amputation of any etiology at the Rizzoli Orthopedic Institute from 2015 to 2017 with the presence of analgesia data for surgery in a computerized record (SIR, Rizzoli information system). A questionnaire for the detection of residual limb pain will be administrate to all the survivors.

Diagnostic Test: Questionnaire

Interventions

Questionnaire DIAGNOSTIC_TEST

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)

Amputees

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients amputated above and below the knee at the Orthopedic Divisions of the Rizzoli Orthopedic Institute

You may qualify if:

• Patients undergoing trans-tibial and trans-femoral amputation of any etiology at the Rizzoli Orthopedic Institute from 2015 to 2017
• Presence of analgesia data for surgery in a computerized record (SIR, Rizzoli information system)
• Patients who have accepted to join the study

You may not qualify if:

• Patients with a medical record inaccessible via SIR (not yet digitized)
• Deceased patients
• Patients under the age of 18
• Non-ambulatory patients

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead
• I.R.C.C.S. Fondazione Santa Lucia: collaborator

Study Sites (1)

IRCCS-Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location

MeSH Terms

Interventions

Pain Measurement

Intervention Hierarchy (Ancestors)

Neurologic Examination; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Maria Grazia Benedetti

  IRCCS-Istituto Ortopedico Rizzoli

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head Physical Medicine and Rehabilitation Unit

Study Record Dates

• First Submitted: December 27, 2018
• First Posted: December 28, 2018
• Study Start: March 7, 2019
• Primary Completion: August 31, 2019
• Study Completion: September 30, 2019
• Last Updated: January 13, 2020

Record last verified: 2020-01

Locations

IT (1)