Preemptive analgesia for hemorrhoidectomy: study protocol for a prospective, randomized, double-blind trial

Ekaterina Kazachenko, Tatiana Garmanova, Alexander Derinov, Daniil Markaryan, Hanjoo Lee, Sabrina Magbulova, Petr Tsarkov, Ekaterina Kazachenko, Tatiana Garmanova, Alexander Derinov, Daniil Markaryan, Hanjoo Lee, Sabrina Magbulova, Petr Tsarkov

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.

Keywords: Analgesics; Anorectal surgery; Hemorrhoidectomy; Pain management; Preemptive analgesia.

Conflict of interest statement

The authors declare that they have no competing interests.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Trial flow diagram

References

    1. Sneddon LU. Comparative physiology of nociception and pain. Physiology (Bethesda). 2018;33(1):63–73. doi: 10.1152/physiol.00022.2017.
    1. Van Backer JT, Jordan MR, Leahy DT, Moore JS, Callas P, Dominick T, et al. Preemptive analgesia decreases pain following anorectal surgery: a prospective, randomized, double-blinded, placebo-controlled trial. Dis Colon Rectum. 2018;61(7):824–829. doi: 10.1097/DCR.0000000000001069.
    1. Gallo G, Martellucci J, Sturiale A, Clerico G, Milito G, Marino F, Cocorullo G, Giordano P, Mistrangelo M, Trompetto M. Consensus statement of the Italian Society of Colorectal Surgery (SICCR): management and treatment of hemorrhoidal disease. Tech Coloproctol. 2020;24(2):145–164. doi: 10.1007/s10151-020-02149-1.
    1. Penprase B, Brunetto E, Dahmani E, Forthoffer JJ, Kapoor S. The efficacy of preemptive analgesia for postoperative pain control: a systematic review of the literature. AORN J. 2015;101(1):94–105.e8. doi: 10.1016/j.aorn.2014.01.030.
    1. Huang YJ, Chen CY, Chen RJ, Kang YN, Wei PL. Topical diltiazem ointment in post-hemorrhoidectomy pain relief: a meta-analysis of randomized controlled trials. Asian J Surg. 2018;41(5):431–437. doi: 10.1016/j.asjsur.2017.06.002.
    1. Liu JW, Lin CC, Kiu KT, Wang CY, Tam KW. Effect of glyceryl trinitrate ointment on pain control after hemorrhoidectomy: a meta-analysis of randomized controlled trials. World J Surg. 2016;40(1):215–224. doi: 10.1007/s00268-015-3344-6.
    1. Frasco PE, Sprung J, Trentman TL. The impact of the joint commission for accreditation of healthcare organizations pain initiative on perioperative opiate consumption and recovery room length of stay. Anesth Analg. 2005;100(1):162–168. doi: 10.1213/01.ANE.0000139354.26208.1C.
    1. Poylin V, Quinn J, Messer K, Nagle D. Gabapentin significantly decreases posthemorrhoidectomy pain: a prospective study. Int J Colorectal Dis. 2014;29(12):1565–1569. doi: 10.1007/s00384-014-2018-4.
    1. Wu JI, Lu SF, Chia YY, Yang LC, Fong WP, Tan PH. Sevoflurane with or without antiemetic prophylaxis of dexamethasone in spontaneously breathing patients undergoing outpatient anorectal surgery. J Clin Anesth. 2009;21(7):469–473. doi: 10.1016/j.jclinane.2008.11.007.
    1. Khalili G, Janghorbani M, Saryazdi H, Emaminejad A. Effect of preemptive and preventive acetaminophen on postoperative pain score: a randomized, double-blind trial of patients undergoing lower extremity surgery. J Clin Anesth. 2013;25(3):188–192. doi: 10.1016/j.jclinane.2012.09.004.
    1. Richman IM. Use of Toradol in anorectal surgery. Dis Colon Rectum. 1993;36(3):295–296. doi: 10.1007/BF02053515.
    1. Chen JY, Ko TL, Wen YR, Wu SC, Chou YH, Yien HW, Kuo CD. Opioid-sparing effects of ketorolac and its correlation with the recovery of postoperative bowel function in colorectal surgery patients: a prospective randomized double-blinded study. Clin J Pain. 2009;25(6):485–489. doi: 10.1097/AJP.0b013e31819a506b.
    1. Aubrun F, Langeron O, Heitz D, Coriat P, Riou B. Randomised, placebo-controlled study of the postoperative analgesic effects of ketoprofen after spinal fusion surgery. Acta Anaesthesiol Scand. 2000;44(8):934–939. doi: 10.1034/j.1399-6576.2000.440807.x.
    1. Fletcher D, Nègre I, Barbin C, François A, Carreres C, Falgueirettes C, Barboteu A, Samii K. Postoperative analgesia with i.v. propacetamol and ketoprofen combination after disc surgery. Can J Anaesth. 1997;44(5 Pt 1):479–485. doi: 10.1007/BF03011934.
    1. Hiller A, Meretoja OA, Korpela R, Piiparinen S, Taivainen T. The analgesic efficacy of acetaminophen, ketoprofen, or their combination for pediatric surgical patients having soft tissue or orthopedic procedures. Anesth Analg. 2006;102(5):1365–1371. doi: 10.1213/.
    1. Oberhofer D, Skok J, Nesek-Adam V. Intravenous ketoprofen in postoperative pain treatment after major abdominal surgery. World J Surg. 2005;29(4):446–449. doi: 10.1007/s00268-004-7612-0.
    1. Velásquez GC, Santa Cruz LA, Espinoza MA. Ketoprofen is more effective than diclofenac after oral surgery when used as a preemptive analgesic: a pilot study. J Oral Facial Pain Headache. 2014;28(2):153–158. doi: 10.11607/ofph.1200.
    1. Gaskell H, Derry S, Wiffen PJ, Moore RA. Single dose oral ketoprofen or dexketoprofen for acute postoperative pain in adults. Cochrane Database Syst Rev. 2017;5(5):CD007355. doi: 10.1002/14651858.CD007355.pub3.
    1. Bjørnsson GA, Haanaes HR, Skoglund LA. Ketoprofen 75 mg qid versus acetaminophen 1000 mg qid for 3 days on swelling, pain, and other postoperative events after third-molar surgery. J Clin Pharmacol. 2003;43(3):305–314. doi: 10.1177/0091270002250603.
    1. Place RJ, Coloma M, White PF, Huber PJ, Van Vlymen J, Simmang CL. Ketorolac improves recovery after outpatient anorectal surgery. Dis Colon Rectum. 2000;43(6):804–808. doi: 10.1007/bf02238018.
    1. Cooper SA. Ketoprofen in oral surgery pain: a review. J Clin Pharmacol. 1988;28(s1):S40–S46. doi: 10.1002/j.1552-4604.1988.tb05976.x.

Source: PubMed

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