Comparative Efficacy of Topical Trailokya Vijaya Gel Versus 2% Lignocaine Gel for Postoperative Pain Management in Anorectal Surgeries: A Randomized, Open-Label Clinical Trial
Authors: Dr. Tanishka Gupta, Dr. Sanjay Srivastava, Dr. Maninder Singh Sisodiya, Dr. Shaloni Sharma
Background: Postoperative pain following anorectal surgeries is a significant clinical challenge, affecting approximately 50% of patients and impeding recovery. Lignocaine gel 2%, though effective, offers only short-duration analgesia. Trailokya Vijaya Gel, a herbal formulation derived from Cannabis sativa (Bhanga) and Bambusa manna (Tugakshiri), was hypothesized to provide sustained analgesic, anti-inflammatory, and wound-healing benefits via cannabinoid-mediated mechanisms.
Aim: To evaluate and compare the onset, peak efficacy, and duration of analgesia of Trailokya Vijaya Gel versus 2% Lignocaine Gel in postoperative pain management following anorectal surgeries.
Methods: A randomized, open-label, comparative clinical trial was conducted on 40 patients undergoing anorectal surgeries (haemorrhoidectomy, fistulotomy, fissurectomy, Ksharasutra ligation) at Sanjeevani Ayurveda Hospital, DSRRAU, Jodhpur. Patients were equally allocated to Group A (Lignocaine Gel 2%, n=20) and Group B (Trailokya Vijaya Gel, n=20). Pain intensity was assessed using the Visual Analogue Scale (VAS) at baseline and at 1, 2, 5, 10, 20 minutes and 2, 4, 6, 8, 10 hours post-intervention. Statistical analysis used the Wilcoxon signed-rank test for intra-group and Mann-Whitney U test for inter-group comparisons.
Results: Both interventions significantly reduced postoperative pain from baseline (p<0.001). Group B demonstrated a markedly faster onset: 49.18% pain relief at 1 minute versus no change in Group A (p<0.001). Peak analgesic efficacy was comparable between groups at 10-20 minutes (Group A: ~73%; Group B: ~70%; p>0.05). However, Group B maintained significantly superior pain control throughout the 2-10 hour observation period (Group B: 30.60-60.66% relief versus Group A: 20.25-55.21%; p<0.05 to p<0.001 at all intervals). No adverse reactions were recorded in either group.
Conclusion: Trailokya Vijaya Gel exhibited faster onset, equivalent peak analgesia, and significantly prolonged duration of pain relief compared to Lignocaine Gel 2%, with an excellent safety profile. It represents a promising herbal-based alternative for postoperative analgesia in anorectal surgery, warranting further large-scale investigation.
Introduction
The text describes a clinical research study comparing a traditional Ayurvedic formulation (Trailokya Vijaya Gel) with standard 2% lignocaine gel for managing postoperative pain after anorectal surgeries.
Postoperative anorectal pain is common due to the high nerve supply in the region and can delay recovery if not properly managed. While lignocaine gel provides short-term local anesthesia, its effect is brief and limited. Ayurvedic medicine, particularly Cannabis-based Bhanga combined with Bambusa-derived Tugakshiri, is proposed to have analgesic, anti-inflammatory, and wound-healing properties, forming the basis of Trailokya Vijaya Gel.
A randomized clinical trial with 40 patients compared both treatments. Pain levels were measured using the Visual Analogue Scale over time after application. Results showed that Trailokya Vijaya Gel acted faster, providing significant pain relief within 1 minute, while lignocaine had a delayed onset. Both treatments had similar peak pain relief, but the Ayurvedic gel provided longer-lasting analgesia over several hours. No adverse effects were reported in either group.
The study concludes that Trailokya Vijaya Gel may be a safe and effective alternative to lignocaine, offering quicker onset and prolonged pain relief for postoperative anorectal pain.
Conclusion
Trailokya Vijaya Gel, formulated from standardised Bhanga (Cannabis sativa) and Tugakshiri (Bambusa manna) extracts, demonstrated statistically significant advantages over 2% Lignocaine Gel in postoperative pain management following anorectal surgeries. It exhibited a markedly faster onset of analgesia (within 1 minute), comparable peak analgesic efficacy at 10-20 minutes, and significantly prolonged pain control sustained throughout a 10-hour observation period, with an excellent safety profile and no adverse reactions. These findings provide clinical validation for the Ayurvedic concept of Vedanasthapana and support the integration of this evidence-based herbal formulation into multimodal postoperative analgesia protocols for anorectal surgery. The study supports the alternate hypothesis that a significant difference exists between the two formulations, favouring Trailokya Vijaya Gel. Larger randomised controlled trials with blinded assessment, pharmacokinetic analysis, and extended follow-up are recommended to consolidate these findings and facilitate clinical adoption.
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