ABSTRACT
BACKGROUND: Hemorrhoidectomy is associated with intense postoperative pain that requires multimodal analgesia. It includes nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen, and local anesthetics to reach adequate pain control. There are data in literature preemptive analgesia could decrease postoperative pain after hemorrhoidectomy. The aim of this study is to assess the efficacy of preemptive analgesia with ketoprofen 100 mg 2 h before procedure per os with spinal anesthesia to decrease postoperative pain according to visual analog scale and to reduce the opioids and other analgesics consumption. METHODS: Patients of our clinic who meet the following inclusion criteria are included: hemorrhoids grade III-IV and the planned Milligan-Morgan hemorrhoidectomy. After signing the consent all participants are randomly divided into 2 groups: the first one gets a tablet with 100 mg ketoprofen, the second one gets a tablet containing starch per os 2 h before surgery (72 participants per arm). Patients of both arms receive spinal anesthesia and undergo open hemorrhoidectomy. Following the procedure the primary and secondary outcomes are evaluated: opioid administration intake, the pain at rest and during defecation, duration, and frequency of other analgesics intake, readmission rate, overall quality of life, time from the procedure to returning to work, and the complications rate. DISCUSSION: Multimodality pain management has been shown to improve pain control and decrease opioid intake in patients after hemorrhoidectomy in several studies. Gabapentin can be considered as an alternative approach to pain control as NSAIDs have limitative adverse effects. Systemic admission of ketorolac with local anesthetics also showed significant efficacy in patients undergoing anorectal surgery. We hope to prove the efficacy of multimodal analgesia including preemptive one for patients undergoing excisional hemorrhoidectomy that will help to hold postoperative pain levels no more than 3-4 points on VAS with minimal consumption of opioid analgesics. TRIAL REGISTRATION: ClinicalTrial.gov NCT04361695 . Registered on April 24, 2020, version 1.0.
Subject(s)
Analgesia , Hemorrhoidectomy , Hemorrhoids , Ketoprofen , Analgesia/adverse effects , Analgesics/adverse effects , Analgesics, Opioid/adverse effects , Anesthetics, Local/adverse effects , Anti-Inflammatory Agents, Non-Steroidal/therapeutic use , Double-Blind Method , Hemorrhoidectomy/adverse effects , Hemorrhoids/diagnosis , Hemorrhoids/surgery , Humans , Ketoprofen/adverse effects , Pain, Postoperative/diagnosis , Pain, Postoperative/etiology , Pain, Postoperative/prevention & control , Prospective Studies , Quality of Life , Randomized Controlled Trials as TopicSubject(s)
Hemorrhoidectomy , Hemorrhoids , Feces , Hemorrhoids/surgery , Humans , Lasers , Ligation , MaleABSTRACT
INTRODUCTION: Hemorrhoidal artery ligation (HAL) with Doppler guidance and suture fixation of hemorrhoidal nodes (RAR) is a popular minimally invasive technique for hemorrhoidal disease (HD) treatment which uses an ultrasound probe to detect hemorrhoidal arteries for further ligation. We hypothesized that ultrasound guidance has no advantages over manual hemorrhoidal arteries detection for HD treatment.The aim is to compare the results of HAL-RAR procedure in patients with stage II-III HD with Doppler and manual HA detection.In this ongoing randomized, controlled, single center clinical study 204 patients randomly divides into group A (HAL-RAR with Doppler US navigation) and group B (HAL with manual HA detection and mucopexy) are planned to be included. The primary endpoint was recurrence of any symptoms of HD; secondary endpoints were pain syndrome severity, treatment satisfaction (1 to 5 points), and need for the drug therapy in 30 days and 8 weeks after surgery. CONCLUSION: Ultrasound guidance technology of HAL with mucopexy could have the same efficacy the manual HA detection regarding the HD treatment effectiveness and patient satisfaction.
