Shahram Ala1, Mina Alvandipour2, Majid Saeedi3, Maliheh Hamidian1, Afshin Shiva4, Nasrin Rahmani5, Fatemeh Faramarzi1. 1. Department of Clinical Pharmacy, Faculty of Pharmacy, Pharmaceutical Research Center, Mazandaran University of Medical Sciences, Sari, Mazandaran Province, Iran. 2. Department of Surgery, Faculty of Medicine, Mazandaran University of Medical Sciences, Sari, Mazandaran Province, Iran. Minaalvh@yahoo.com. 3. Department of Pharmaceutics, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Mazandaran Province, Iran. 4. Department of Clinical Pharmacy, Faculty of Pharmacy, Inpatient's Safety Research Center, Urmia University of Medical Sciences, Urmia, Iran. 5. Department of Surgery, Faculty of Medicine, Mazandaran University of Medical Sciences, Sari, Mazandaran Province, Iran.
Abstract
BACKGROUND:Atorvastatin is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA) reductase inhibitor widely used in treatment of hypercholesterolemia and prevention of coronary heart disease and has various pleiotropic effects. In this study, the efficacy of atorvastatin emulgel (2 %) in reducing postoperative pain at rest, pain during defecation and analgesic requirement after open hemorrhoidectomy was investigated. METHODS: A total of 66 patients with third- and fourth-degree hemorrhoids undergoing openhemorrhoidectomy were included in this prospective, double-blind, randomized controlled trial. The patients were randomly assigned to either atorvastatin emulgel or placebo immediately after surgery and then every 12 h for 14 days. The primary outcomes were intensity of pain at rest and during defecation, measured with a visual analog scale, and the analgesic requirement, measured by amount of pethidine and acetaminophen consumption, and percent of wound healing. RESULTS: There was no significant difference in the average postoperative pain scores in the first 48 h (P 12h = 1, P 24h = 0.128 and P 48h = 0.079) after the surgery between the two groups, but at the week 1 the pain scores during defecation were considerably lower in the atorvastatin group than in placebo group (P = 0.004), which also was the same at the week 2 (P = 0.03). There was no significant difference in the average pethidine and acetaminophen (mg) administration at 12 h and 24 h between the two groups after surgery. Regarding the data about wound healing, at the week two the healing was much better in the treatment group than it was in control group and the difference was statistically significant (P = 0.04). CONCLUSIONS: Compared with placebo, atorvastatin emulgel reduced postoperative pain at rest and on defecation and could improve the healing process after open hemorrhoidectomy. TRIAL REGISTRATION NUMBER: IRCT201404013014N8.
RCT Entities:
BACKGROUND:Atorvastatin is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA) reductase inhibitor widely used in treatment of hypercholesterolemia and prevention of coronary heart disease and has various pleiotropic effects. In this study, the efficacy of atorvastatin emulgel (2 %) in reducing postoperative pain at rest, pain during defecation and analgesic requirement after open hemorrhoidectomy was investigated. METHODS: A total of 66 patients with third- and fourth-degree hemorrhoids undergoing open hemorrhoidectomy were included in this prospective, double-blind, randomized controlled trial. The patients were randomly assigned to either atorvastatin emulgel or placebo immediately after surgery and then every 12 h for 14 days. The primary outcomes were intensity of pain at rest and during defecation, measured with a visual analog scale, and the analgesic requirement, measured by amount of pethidine and acetaminophen consumption, and percent of wound healing. RESULTS: There was no significant difference in the average postoperative pain scores in the first 48 h (P 12h = 1, P 24h = 0.128 and P 48h = 0.079) after the surgery between the two groups, but at the week 1 the pain scores during defecation were considerably lower in the atorvastatin group than in placebo group (P = 0.004), which also was the same at the week 2 (P = 0.03). There was no significant difference in the average pethidine and acetaminophen (mg) administration at 12 h and 24 h between the two groups after surgery. Regarding the data about wound healing, at the week two the healing was much better in the treatment group than it was in control group and the difference was statistically significant (P = 0.04). CONCLUSIONS: Compared with placebo, atorvastatin emulgel reduced postoperative pain at rest and on defecation and could improve the healing process after open hemorrhoidectomy. TRIAL REGISTRATION NUMBER: IRCT201404013014N8.
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