Survey
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
6. BRIEF RESUME OF THE INTENDED WORK: 6.1 Need for the study: The International Association for the Study of Pain defines pain as “an unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage”. In case of postoperative pain the cause is tissue injury. Untreated postoperative pain can lead to some of the acute effects like sympathetic nervous system activation and neuroendocrine stress response resulting in increased morbidity and mortality. It is also an important predictive factor in the development of long term chronic pain. The goal of postoperative pain management is to reduce or eliminate pain and discomfort with minimum side effects. There are many methods to control pain, of which opioid analgesics are one of the corner stone option in the management of pain. However opioid drugs differ from each other with respect to efficacy, potency, sedation and side effects. Tramadol is an weak opioid agonist. It also inhibit the reuptake of the serotonin and norepinephrine and used in mild to moderate pain relief. Nalbuphine is a newer opioid drug with antagonism at μ receptor and agonism at κ receptor. Hence my study is selected to compare the efficacy and side effects of these two drugs. 6.2 Review of Literature: In a study of 40 patients posted for abdominal hysterectomy, 20 patients received intravenous bolus nalbuphine followed by continuous infusion. The other 20 received intravenous bolus tramadol followed by continuous infusion. They concluded that more supplemental analgesia was required in the tramadol group and general well being was better in the nalbuphine group.1 In a study of 24 children aged 1-10 years undergoing scheduled surgical procedure, half of them received intravenous bolus dose of nalbuphine followed by infusion and the other half received intravenous bolus dose of tramadol followed by infusion, both for a duration of 72 hr. Sedation was more in the nalbuphine group whereas vomiting was more in tramadol group. The requirement of extra bolus dose was three times more frequent in the nalbuphine group compared to tramadol group. 2 A study was conducted on 56 postoperative patients to compare the relative analgesic potency of intramuscular nalbuphine and morphine. It was concluded that nalbuphine was 0.8 to 0.9 times as potent as morphine with no psychomimetic reactions which is more common with morphine.3 In a study on 80 patients posted for elective hip and knee arthroplasty to assess the clinical efficacy of tramadol and morphine using PCA delivery system, it was concluded patient satisfaction was more with morphine. Nausea and vomiting was more with tramadol. Morphine produced more sleepiness.4 In a study of 126 patient under going abdominal hysterectomy the analgesic effectiveness and side effects of intravenous patient controlled morphine,pethidine and tramadol were compared. All the three drug have equivalent pain scores and side effects but tramadol group required more frequent use of rescue analgesic.5 In another study comparing nalbuphine hydrochloride with pethidine after elective orthopaedic surgery, both drugs were given intramuscularly on the first day postoperatively. It was observed that nalbuphine had a longer duration of action whereas pethidine had more respiratory depressant action.6 6.3 Objectives of the study: 1. To compare the analgesic efficacy of tramadol with nalbuphine in the postoperative period. 2. To compare the propensity to cause sedation between tramadol and nalbuphine. 3. To determine the occurrence of adverse effects with tramadol and nalbuphine. 7. Materials and Methods: 7.1 Source of Data: Patients aged between 35-60 years, ASAgrade 1-3 posted for lower abdominal surgeries under subarachnoid block in A. J. Hospital, Mangalore between september 2009 and september 2010. 7.2 Method of the Collection of the Data (Including sampling procedures if any) : 50 patients aged between 35-60 years posted for lower abdominal surgeries were divided in to two groups (Group N & Group T) on the basis of random sampling method. Group N will receive 0.1mg/kg body weight of nalbuphine intravenously when pain is complained of postoperatively and repeated every 6th hourly for 24hours. Group T will receive 1mg/kg body weight of tramadol intravenously when pain is complained of postoperatively and repeated every 6th hourly for 24hours. The same analgesic is to be repeated intravenously, half the dosage for breakthrough pain. Inclusion criteria: Fifty patients of ASAgrade 1-3 between the age group of 35-60 yr posted for lower abdominal surgeries. Exclusion criteria: 1. Patients allergic to the study drugs. 2.Patients on oral anticoagulant therapy neuroleptic agent MAO inhibitor 3. Patients with History of epilepsy Increased intracranial tension History of motion sickness History of opioid use over the last 1 month Parameters to be studied: 1) Analgesic efficacy of study drugs as evidenced by Visual Analogue Scale and Verbal Category Scale at 30 minutes, 3 hours, 6 hours after each dose over the first 24 hours postoperatively. 2) Sedation score at 30minunes, 3hours, 6hours after each dose over the first 24 hours postoperatively 3) Vitals of the patient i.e pulse rate, blood pressure, respiratory rate and peripheral oxygen saturation hourly over the first 24 hours postoperatively. 7.3 Does the study require any investigations or interventions to be conducted on patients or other humans or animals? If so, please describe briefly. Yes, routine investigations namely complete haemogram, E.C.G, urine analysis, blood sugar, renal function tests have to be done. 8. List of References: 1) Alon E, Atanassoff PG, Biro P.Intravenous postoperative pain management using nalbuphine and tramadol. Anaesthesist 1992 Feb;41(2):83-87 2) Moyao-Garcia D, Hernandaz-Palacios JC, Ramfrez-Mora JC, . Nava-ocampa AA. A pilot study of nalbuphine versus tramadol administered through continuous intravenous infusion for postoperative pain control in children.Acta Biomed. 2009 ;84 :124-130. 3) Beaver WT, Feise GA. A comparison of the analgesic effect of intramuscular nalbuphine and morphine in patient with postoperative pain. Pharmacology and Experimental Therapeutics.1978;204(2):487-496. 4) Pang WW, Mok MS, Lin CH, Huang MH. Comparison of patient controlled analgesia with tramadol or morphine.Can J Anesth 1999;46(11): 1030-1035. 5) Unlugene H, Vardar MA, Tetiker S. A Comparitive study of the analgesic effect of patient controlled morphine, pethidine, and tramadol for postoperative pain management after abdominal hysterectomy. Anesth Analg 2008; 106:309-312. 6) Brock – Utne J.G, Ritchie P, .Downing J.W. A comparison of nalbuphine and pethidine for post operative pain relief after orthopaedic surgery.S Afr Med J 1985; 68:391-393.