Lower Limb Amputation Above Knee Clinical Trial
Official title:
Medium-term Incidence Study of Phantom Limb Syndrome in Trans Femoral and Trans Tibial Amputated Patients
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.
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.
Methods Administration (post delivery and supervised compilation by telephone) of the
Prosthetic Evaluation Questionnaire (PEQ), of the Houghton Scale of Prosthetic Use in People
with Lower-Extremity Amputations and collection of general information : presence and
severity of the stump pain, phantom limb pain and phantom limb sensation, weight, height,
type of prosthesis and time of use, specific rehabilitation for phantom limb, pharmacological
therapy in place.
Type of anesthesia used during surgery and general and local analgesic therapy (perinervous
or peridural catheters) used will be retrieved from clinical folders.
Timetable Month 1
- Request to the Institute Informatic System of the identification of patient records with
amputation above or below the knee in the years 2015-2017
- Search for computerized folders and data collection of anesthesia and analgesia in a
database Month 2
- Identification of patients eligible for the study with consultation of the registry for
the search for the deceased
- Sending patient questionnaires and phone calls for completion Month 3
- Collection of questionnaires
- Completion of the database
- Statistic analysis
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03578237 -
Cryoanalgesia to Prevent Acute and Chronic Pain Following Surgery: A Randomized, Double-Masked, Sham-Controlled Study
|
N/A |