Comparison of Efficacy of Diclofenac versus Aceclofenac in Post Operative Pain in Lower limb fractures: a Double blind, Randomized Study

摘要

INTRODUCTION: Providing effective postoperative analgesia is a significant challenge in patients undergoing orthopedic surgery. Non steroidal anti-inflammatory group of drugs is used mostly to achieve it. This clinical study was done to investigate efficacy of Injectable Aceclofenac over inj. Diclofenac in patients with severe postoperative pain in lower limb fractures. METHODS: 100 patients (aged 18-60 yr) of lower limb fractures were enrolled as per inclusion criteria . They were randomly assigned to Group A or Group B (50 patients each ) .Severe pain was postoperative pain 7 or >7 on Numerical Rating Scale. For postoperative analgesia, in Group A Inj. Aceclofenac ( 12 hourly) and in Group B Inj. Diclofenac (8 hourly) was given . To abort pain in case of no relief Inj. Tramadol was given. Decrease in Numerical Rating Scale score in either the group and associated adverse effects were noted . Patients’ overall subjective response to therapy was rated as poor , fair , good or excellent .RESULTS: After treatment at 10 min. only the mean pain score had 47.8% fall in Group A and 40.3% in Group B. At the end of 20 min. percentage fall was more in Group A (88.1%) than Group B patients (68.9%).Group A patients received less rescue analgesia than Group B (p<0.05) .At the end of 24 hr period 60% patients in Group A and 40% patients in Group B reported outcome as good or excellent . CONCLUSION: The study demonstrated superiority of Inj.Aceclofenac to Inj. Diclofenac in providing postoperative pain relief. Aceclofenac demonstrated a favourable tolerability profile than Diclofenac along with lesser frequency of administration due to longer half life. Introduction Postoperative pain remains a routine problem in orthopedic surgery. Parenteral Nonsteroidal Ant inflammatory Drugs (NSAIDS) are an attractive option in providing postoperative analgesia. They are effective in a wide range of postoperative pain states as adverse effects with them are considerably less1. Aceclofenc a phenylacetic acid derivative (2-2,6-dichlorophenyl amino Phenylacetooxyacetic acid ) is related to Diclofenac . In injectable form it is clinically useful in reduction of postoperative pain2. . It acts by inhibition of cyclo-oxygenase , thus reducing bio synthesis of pain mediating and inflammatory prostaglandins and also by direct inhibition of spinal nociceptor processing3,4. The present study aims at the evaluation of the analgesic activity, efficacy and safety of Aceclofenac injection 150mg/ml versus Diclofenac injection 75 mg/3 ml in management of postoperative pain of severe intensity in patients with Lower Limb Fractures. Materials and Methods This was a prospective double blind randomized study conducted at Dr. Rajendra Prasad Medical College and Hospital Kangra (Tanda) in the year 2006-2008. Written informed consent was obtained from all participating patients. A total number of 100 patients , male and female aged 18-60 years with Lower Limb Fractures distal to knee joint , scheduled to undergo surgery were selected . Exclusion criteria for the present study were hypersensitivity to NSAID, severe hepatorenal or cardiac dysfunction , gastrointestinal bleed/clotting disorders, pregnant or lactating mothers and patients unwilling to comply with protocol requirements .At a presurgical visit, patients were evaluated for inclusion .Baseline assessment was performed including a medical history, diagnosis and nature of lower limb surgery to be performed. A careful examination including pulse rate and blood pressure recording was done prior to surgery and postoperatively immediately and at 10 min,20 min,30 min,1hr,4 hr,8hr and 12 hrs. Biochemical, hematological, urine examination and ECG were done in all the patients pre and postoperatively. Treatment with any analgesic was forbidden 8 hrs following injections of study medication. Alcohol, Anticoagulant therapy or any other cross reacting drugs were forbidden. Study medication was to be given to the patients on first