الفهرس 
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Abstract
Persistent pain after amputation is an important clinical problem with no reliably effective treatment[6]. Treatment of phantom pain has been attempted at all levels of pain transmission and perception: peripheral, spinal, and central. The underlying mechanisms are not understood, but it is clear that major changes occur in the peripheral and central nervous system in response to peripheral nerve injury and subsequent alterations in peripheral sensory input[15]. Central sensitization, occurring at the level of the spinal cord, is likely to play a key role in ongoing pain[16]. Clinical studies implicate that the transmission of noxious afferent input from the periphery to the spinal cord induces a prolonged state of central neural sensitization, which amplifies subsequent input leading to persistent neuropathic pain[17, 18].
The aim of our study is to improve management of phantom limb pain (PLP) in patients having lower limb amputations by assessing and comparing the effect of peri-operatively modulating sensory input within pregabalin and tramadol groups and their combination versus a control group regarding the incidence and severity of phantom limb pain (PLP).
This study was a randomized double-blind controlled clinical trial on 84 American Society of Anesthesiologists (ASA) physical status I, ІІ, and III patients[180] undergoing above or below knee amputation under spinal anesthesia that took place at Suez Canal University Hospital in the emergency surgical theatres, surgical inward and outpatient pain clinic.
Patients were randomly assigned into one of four equal groups;
Group C: (21 patients) received oral placebo 50, 38, 26, 14 and 2 hours preoperatively and 10, 22, 34 and 46 hours postoperatively.
Group P: (21 patients) received oral pregabalin capsules (150 mg every 12 hours) 50, 38, 26, 14 and 2 hours preoperatively and 10, 22, 34 and 46 hours postoperatively.
Group T: (21 patients) received oral tramadol tablets (100 mg every 12 hours) 50, 38, 26, 14 and 2 hours preoperatively and 10, 22, 34 and 46 hours postoperatively.
Group PT: (21 patients) received both oral pregabalin capsules (150 mg every 12 hours) and oral tramadol tablets (100mg every 12 hours) 50, 38, 26, 14 and 2 hours preoperatively and 10, 22, 34 and 46 hours postoperatively.
All patients were assessed preoperatively for demographic, clinical characteristics and laboratory findings. They were interviewed using several questionnaires at 6 endpoints. These questionnaires were Short-Form McGill Pain Questionnaire (SF-MPQ) [28] [for assessment of PPI & overall pain intensity VAS]; and DN4 Neuropathic Pain Diagnostic Questionnaire[29] [for presence of neuropathy]; Daily Sleep Interference Scale (DSIS)[30] [for assessment of sleep quality]; and change in the patient’s overall status using Patients’ Global Impression of Change (PGIC)[31]. Incidence, intensity (mild, moderate, severe) and frequency (daily, weekly, monthly) of PLP were recorded during the 3-month follow-up period.. Postoperative morphine consumption was also recorded.
Endpoint 1: Before starting the study medication (48-hr preoperatively)
Endpoint 2: Before induction of Anesthesia (Spinal anesthesia)
Endpoint 3: After the last dose of postoperative medication (48-hr postoperatively)
Endpoint 4: At 4-week endpoint (4 weeks postoperatively)
Endpoint 5: At 8-week endpoint (8 weeks postoperatively)
Endpoint 6: At 12-week endpoint (12 weeks postoperatively)
Patients who developed residual (stump) limb pain during the follow-up period continued participation in the study for the remaining follow-up period. They were counseled and managed in Suez Canal University Hospital outpatient surgical clinic. Incidence on RLP was recorded.
Comparing tramadol, pregabalin or their combination versus a placebo drug, showed that the best analgesic efficiency was in the combination therapy followed by tramadol treatment. This was evident preoperatively by lower VAS values just prior to surgery, and post-operatively by lower morphine consumption. Pregabalin group showed lower incidence of sleep interference with better control of neuropathic symptoms following amputations compared to the control and tramadol groups. Combination group showed the best control for pain and neuropathy as well as least sleep interference with no incidence of phantom limb pain; however, patients had the highest incidence of medication-related adverse effects.
We recommend that routine adequate analgesic pain control regimen for an appropriate duration prior and after major lower limb amputations is essential to prevent phantom limb pain and either tramadol or pregabalin or their combination could be a proper additive to peri-operative therapy of phantom limb if not contraindicated, although a larger multicenter study is required