Oral Drotaverine and Aceclofenac Combination versus Aceclofenac alone for Postoperative Pain Relief: A Prospective Randomized Clinical Trial

Address for Correspondence: Dr Ashish Dey, Room 1317, Department of General Surgery, Sir Ganga Ram Hospital, Old Rajinder Nagar, New Delhi – 110060 E-mail: [email protected], [email protected] Indian Journal of Pharmacy Practice Volume 6 Issue 4 Oct Dec, 2013 18 Both male and female patients between 18 and 60 years of age admitted for laparoscopic surgeries of hollow visceral organs not necessitating restriction of oral feeds were recruited. Because both the drugs had o be given orally, procedures needing bowel resection or extensive bowel handling were excluded from this study that would have precluded early resumption of feeding. The exclusion criteria are mentioned in Table I. Randomization was done by a computer-generated s e q u e n c e , w i t h t h e h e l p o f t h e s o f t w a r e www.randomization.com, and stored in sealed opaque envelopes. Statistical analysis was performed by the SPSS program for Windows, version 17.0. Data was checked for normality before statistical analysis using ShaiproWilk test. Continuous variables are presented as mean ± Standard Deviation (SD) or Median Interquartile Range (IQR) if the data is non-normal, and categorical variables are presented as absolute numbers and percentage. The comparison of normally distributed continuous variables between the groups was performed using Student's t test to compare their relative efficacies. Nominal categorical data between the groups were compared using Chi-square test as appropriate. Non-normal distribution continuous variables were compared using Man Whitney U test and for all statistical tests, a p value less than 0.05 was taken to indicate a significant difference. A Sample size of 70 per group was calculated based on a difference of 1 in patients' 2 VAS scores between groups, a population variance of (2) , a two-sided α of 0.05, and a power of 80%.