Journal of minimal access surgery · 2025
Effectiveness of multimodal analgesic regimen versus standard care during laparoscopic cholecystectomy: A randomised controlled trial.
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Badkur Mayank, Patel Seema, Choudhary Indra Singh, Karthik N, Raj Shakti, Goel Akhil Dhanesh, Paliwal Bharat, Shukla Kamla Kant, Lodha Mahendra, Meena Satya Prakash, Singh Radhey Shyam
Аннотация
INTRODUCTION: Laparoscopic cholecystectomy is associated with significant post-operative pain, often hindering same-day discharge. Multimodal analgesia (MMA) combining non-opioid agents is advocated to address this challenge, yet standardised protocols remain elusive. This trial evaluates the efficacy of a structured MMA regimen versus standard care (SOC) in reducing pain, opioid use and surgical stress.
PATIENTS AND METHODS: This randomised controlled trial enrolled 121 patients undergoing laparoscopic cholecystectomy, assigning 60 to standard care and 61 to MMA. The MMA group received intraoperative 0.5% ropivacaine at incision sites, gall bladder fossa and subdiaphragmatic region. The primary outcome was 24-h post-operative pain intensity, measured using the Visual Analogue Scale (VAS). The secondary outcomes included rescue analgesia requirements, inflammatory markers such as C-reactive protein (CRP), cortisol, interleukin-6 (IL-6) and tumour necrosis factor-alpha (TNF-α). Intention-to-treat and per-protocol analyses were conducted using the Mann-Whitney U -test, the Chi-square test and linear mixed-effects models.
RESULTS: MMA significantly reduced median VAS scores by 40% at 3 h (5 [Interquartile range: 4-8] vs. 9 [8-10], P < 0.001, effect size r = 0.61) and 20% at 24 h (3 [1-4] vs. 5 [4-6], P < 0.001, r = 0.49). Rescue analgesia use was 63% lower in the MMA group (67.2% vs. 85%, odds ratio = 0.37, P = 0.02). Inflammatory markers - CRP and cortisol were significantly reduced in the MMA group, while IL-6 and TNF-α showed no differences at the 24 h post-operative period.
CONCLUSION: The MMA regimen effectively reduces post-operative pain, opioid reliance and surgical stress in laparoscopic cholecystectomy, aligning with enhanced recovery protocols. The attenuation of CRP and cortisol highlights MMA's anti-inflammatory benefits.
PATIENTS AND METHODS: This randomised controlled trial enrolled 121 patients undergoing laparoscopic cholecystectomy, assigning 60 to standard care and 61 to MMA. The MMA group received intraoperative 0.5% ropivacaine at incision sites, gall bladder fossa and subdiaphragmatic region. The primary outcome was 24-h post-operative pain intensity, measured using the Visual Analogue Scale (VAS). The secondary outcomes included rescue analgesia requirements, inflammatory markers such as C-reactive protein (CRP), cortisol, interleukin-6 (IL-6) and tumour necrosis factor-alpha (TNF-α). Intention-to-treat and per-protocol analyses were conducted using the Mann-Whitney U -test, the Chi-square test and linear mixed-effects models.
RESULTS: MMA significantly reduced median VAS scores by 40% at 3 h (5 [Interquartile range: 4-8] vs. 9 [8-10], P < 0.001, effect size r = 0.61) and 20% at 24 h (3 [1-4] vs. 5 [4-6], P < 0.001, r = 0.49). Rescue analgesia use was 63% lower in the MMA group (67.2% vs. 85%, odds ratio = 0.37, P = 0.02). Inflammatory markers - CRP and cortisol were significantly reduced in the MMA group, while IL-6 and TNF-α showed no differences at the 24 h post-operative period.
CONCLUSION: The MMA regimen effectively reduces post-operative pain, opioid reliance and surgical stress in laparoscopic cholecystectomy, aligning with enhanced recovery protocols. The attenuation of CRP and cortisol highlights MMA's anti-inflammatory benefits.