Article PDF :

Veiw Full Text PDF

Article type :

Original Article

Author :

Kawita Bapat, Abhijeet Kumar*, Prashant Katke, Ketan Kulkarni, Sachin Suryawanshi

Volume :

11

Issue :

3

Abstract :

Background: Management of acute post-operative pain and swelling after the obstetric and gynaecological (OBG) surgeries is crucial part of patient care. Reduction or complete elimination of post-operative pain & swelling, without excessive sedation is the most preferred treatment strategy helping patient’s recovery in terms of rapid mobilization and return to independence. Serratiopeptidase a proteolytic enzyme used for its anti-inflammatory properties. Diclofenac Sodium is commonly used to treat the pain and swelling. Objective: This study aimed to evaluate the effectiveness and tolerability of the fixed dose combination (FDC) of Serratiopeptidase (10 mg) with Diclofenac Sodium (50 mg) gastro-resistant tablets in day care OBG surgery. Materials and Methods: This was a single centre, retrospective, observational data collection in real-life scenario. Data of adult women who had undergone day care OBG surgery and received a FDC of Serratiopeptidase (10 mg) with Diclofenac Sodium (50 mg) gastro-resistant tablets TID for period of 24 hours was retrieved and analysed. VAS (Visual Analogue Scale) data on post-operative pain at rest and pain on movement as well as post-operative swelling were analyzed in conjunction with monitoring for adverse events. Result: Among 61 patient’s data included in the study, 40 (65.57%) had undergone Minimally Invasive Vaginal Hysterectomy (MIVH), 4 (6.56%) had MIVH with Bilateral Salpingo-oophorectomy, and 17 (27.87%) had other OBG surgeries. The average VAS scores for pain at rest (VAS), pain on movement (VAS) and swelling were significantly reduced compared to baseline at all-time points (p>0.001). Clinical global impression of efficacy and safety for 95% physician’s and 93.3% patients was good to very good. FDC was found to be well tolerated without any serious adverse reaction. Conclusion: The results of this clinical study confirms the effectiveness and tolerability of FDC of Serratiopeptidase and Diclofenac sodium in day care OBG surgeries in the early post-operative period.