RESUMO
BACKGROUND: Haemorrhoidectomy is associated with severe postoperative pain, a long rehabilitation, and QoL worsening for months. Most patients experience mild-to-moderate postoperative pain. We aimed to evaluate the intraoperative perineal block role for patients undergoing haemorrhoidectomy. METHODS: In this prospective randomized, double-blind, placebo-controlled study, eligible patients with III-IV stage haemorrhoids were randomized to the experimental group (EG) with intraoperative perineal block and spinal anaesthesia and the control one (CG) only with spinal anaesthesia. During the postoperative period, the opioid consumption rate was evaluated as a primary endpoint, and the postoperative pain level according to VAS, systemic analgesics consumption, readmission, and complication rate, the timing of returning to work, patients' QoL, and overall satisfaction according to SF-36 were evaluated as secondary endpoints. RESULTS: One hundred patients completed the study (48 in EG and 52 in CG). Patients of the EG had less postoperative pain intensity (P < 0.0001), required less opioid analgesia (P = 0.03), and had longer pain-free postoperative periods (P = 0.0002). 90% of patients in the CG required additional NSAID injections for adequate analgesia compared with only 58% in the EG. The average hospital stays, complication rate, and average operation duration didn't reach clinical significance. General health evaluation according to the SF-36 score and the median satisfaction rate was better in the EG (P < 0.001 and P = 0.012, respectively). CONCLUSIONS: The administration of the perianal block is safe and effective and should be administered to appropriate patients undergoing anorectal surgery.
RESUMO
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.