Preemptive analgesia for hemorrhoidectomy: study protocol for a prospective, randomized, double-blind trial.
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
Humans
Ketoprofen
/ adverse effects
Pain, Postoperative
/ diagnosis
Prospective Studies
Quality of Life
Randomized Controlled Trials as Topic
Analgesics
Anorectal surgery
Hemorrhoidectomy
Pain management
Preemptive analgesia
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
27 Jun 2022
27 Jun 2022
Historique:
received:
07
12
2020
accepted:
15
02
2022
entrez:
27
6
2022
pubmed:
28
6
2022
medline:
30
6
2022
Statut:
epublish
Résumé
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. 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. 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. ClinicalTrial.gov NCT04361695 . Registered on April 24, 2020, version 1.0.
Sections du résumé
BACKGROUND
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
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
CONCLUSIONS
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
BACKGROUND
ClinicalTrial.gov NCT04361695 . Registered on April 24, 2020, version 1.0.
Identifiants
pubmed: 35761383
doi: 10.1186/s13063-022-06107-0
pii: 10.1186/s13063-022-06107-0
pmc: PMC9235219
doi:
Substances chimiques
Analgesics
0
Analgesics, Opioid
0
Anesthetics, Local
0
Anti-Inflammatory Agents, Non-Steroidal
0
Ketoprofen
90Y4QC304K
Banques de données
ClinicalTrials.gov
['NCT04361695']
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
536Informations de copyright
© 2022. The Author(s).
Références
AORN J. 2015 Jan;101(1):94-105.e8
pubmed: 25537330
Dis Colon Rectum. 1993 Mar;36(3):295-6
pubmed: 8449138
World J Surg. 2005 Apr;29(4):446-9
pubmed: 15776297
J Oral Facial Pain Headache. 2014 Spring;28(2):153-8
pubmed: 24822238
Dis Colon Rectum. 2018 Jul;61(7):824-829
pubmed: 29771804
Asian J Surg. 2018 Sep;41(5):431-437
pubmed: 28698000
J Clin Anesth. 2009 Nov;21(7):469-73
pubmed: 19914051
Anesth Analg. 2005 Jan;100(1):162-168
pubmed: 15616072
Acta Anaesthesiol Scand. 2000 Sep;44(8):934-9
pubmed: 10981569
J Clin Anesth. 2013 May;25(3):188-92
pubmed: 23567482
J Clin Pharmacol. 2003 Mar;43(3):305-14
pubmed: 12638400
Dis Colon Rectum. 2000 Jun;43(6):804-8
pubmed: 10859081
Int J Colorectal Dis. 2014 Dec;29(12):1565-9
pubmed: 25269619
World J Surg. 2016 Jan;40(1):215-24
pubmed: 26578318
Clin J Pain. 2009 Jul-Aug;25(6):485-9
pubmed: 19542795
Can J Anaesth. 1997 May;44(5 Pt 1):479-85
pubmed: 9161740
Cochrane Database Syst Rev. 2017 May 25;5:CD007355
pubmed: 28540716
Tech Coloproctol. 2020 Feb;24(2):145-164
pubmed: 31993837
J Clin Pharmacol. 1988 Dec;28(s1):S40-6
pubmed: 3072357
Physiology (Bethesda). 2018 Jan 1;33(1):63-73
pubmed: 29212893
Anesth Analg. 2006 May;102(5):1365-71
pubmed: 16632811