Perioperative Oral Melatonin, Pregabalin and their Combination for Management of Lower Limb Phantom Pain after Spinal Anesthesia
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- Category: Vol. 82, December 2014
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Perioperative Oral Melatonin, Pregabalin and their Combination for Management of Lower Limb Phantom Pain after Spinal Anesthesia, HOSAM M. ATEF
Abstract
Background: Persistent pain after amputation is an impor-tant Clinical problem with no reliably effective treatment. The aim of our study is to improve management of phantom limb pain in patients having lower limb amputations by comparing the effect of peri-operatively oral pregabalin, melatonin or their combination versus a control group regarding the incidence and severity of phantom limb pain.
Methods: This study was a randomized double-blind controlled Clinical trial on 84 ASA Physical status I, II, and III patients undergone above or below knee amputation under spinal anesthesia were done at the Suez Canal University Hospital in the emergency operative theatres, inward and the outpatient pain clinic.
Patients were randomly assigned into one of four equal groups:
Group C: Received an oral placebo; Group P: Received oral pregabalin capsules (150mg every 12 hours); Group M: Received oral melatonin tablets 9mg every 12 hours); Group PM: Received both oral pregabalin capsules (75mg every 12 hours) plus oral melatonin tablets (6mg every 12 hours). All medications were given at 50, 38, 26, 14 and 2 hours preop-eratively and 10, 22, 34 and 46 hours postoperatively. All patients were interviewed using several questionnaires at six endpoints. These questionnaires were Short-Form McGill Pain Questionnaire; Neuropathic Pain Diagnostic Question-naire; Daily Sleep Interference Scale; and Patients’ Global Impression of Change. Incidence, intensity (mild, moderate, severe) and frequency (daily, weekly, monthly) of PLP was recorded during the 3-month follow-up period. Postoperative morphine consumption was also recorded.
Endpoint 1: Before starting medication (48-hour preopera-tively).
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).
Results: Melatonin, pregabalin or their combination versus a placebo drug, showed that combination group followed by melatonin treatment achieved the best control of pain and neuropathy as well as least sleep interference with no incidence of phantom limb pain. This was evident preoperatively by lower VAS values just prior to Surgery, and post-operatively by lower morphine consumption; however, patients had the highest incidence of medication-related adverse effects. The melatonin group showed lower incidence of sleep interference with better control of neuropathic symptoms following ampu-tations compared to the control and pregabalin groups in preoperative periods.
Conclusion: Perioperative oral melatonin or pregabalin or their combination could be a proper additive to peri-operative therapy for phantom limb after spinal Anesthesia. A larger multicenter study is required.