Cargando…

Effect of Nefopam-Based Patient-Controlled Analgesia with and without Fentanyl on Postoperative Pain Intensity in Patients Following Laparoscopic Cholecystectomy: A Prospective, Randomized, Controlled, Double-Blind Non-Inferiority Trial

Background and Objectives: We investigated the non-inferiority of patient-controlled analgesia (PCA), using either nefopam alone or combined nefopam-fentanyl for postoperative analgesia in patients undergoing laparoscopic cholecystectomy. Materials and Methods: In this prospective, randomized, contr...

Descripción completa

Detalles Bibliográficos
Autores principales: Jung, Ki Tae, So, Keum Young, Kim, Seung Chul, Kim, Sang Hun
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8067158/
https://www.ncbi.nlm.nih.gov/pubmed/33801705
http://dx.doi.org/10.3390/medicina57040316
_version_ 1783682736876158976
author Jung, Ki Tae
So, Keum Young
Kim, Seung Chul
Kim, Sang Hun
author_facet Jung, Ki Tae
So, Keum Young
Kim, Seung Chul
Kim, Sang Hun
author_sort Jung, Ki Tae
collection PubMed
description Background and Objectives: We investigated the non-inferiority of patient-controlled analgesia (PCA), using either nefopam alone or combined nefopam-fentanyl for postoperative analgesia in patients undergoing laparoscopic cholecystectomy. Materials and Methods: In this prospective, randomized, controlled study, 78 patients were allocated to receive nefopam 240 mg (Group N240) or nefopam 120 mg with fentanyl 600 μg (Group NF), equivalent to fentanyl 1200 μg, with a total PCA volume of 120 mL. Patients were given a loading dose (0.1 mL/kg) from the PCA device along with ramosetron (0.3 mg) and connected to a PCA device with a background infusion rate of 2 mL/h, bolus dose amount set at 2 mL, and lockout interval set at 15 min. Pain scores were obtained using the numeric rating scale (NRS) at 30 min after recovery room (RR) admission, as well as 8 and 24 h postoperatively. The primary outcome was analgesic efficacy evaluated using NRS-rated 8 h postoperatively. Other evaluated outcomes included the incidence rate of bolus demand, rescue analgesic and antiemetic requirements, and postoperative adverse effects. Results: NRS scores were not significantly different between the groups throughout the postoperative period (p = 0.539). NRS scores of group N240 were not inferior to those of group NF at 30 min after RR admission, or at 8 and 24 h postoperatively (mean difference [95% CI], −0.05 [−0.73 to 0.63], 0.10 [−0.29 to 0.50], and 0.28 [−0.06 to 0.62], respectively). Postoperative adverse effects were not significantly different between the two groups (p = 1.000) and other outcomes were also not significantly different between the two groups (p ≥ 0.225). Conclusions: PCA using nefopam alone has a non-inferior and effective analgesic efficacy and produces a lower incidence of postoperative adverse effects compared to a combination of fentanyl and nefopam after laparoscopic cholecystectomy.
format Online
Article
Text
id pubmed-8067158
institution National Center for Biotechnology Information
language English
publishDate 2021
publisher MDPI
record_format MEDLINE/PubMed
spelling pubmed-80671582021-04-25 Effect of Nefopam-Based Patient-Controlled Analgesia with and without Fentanyl on Postoperative Pain Intensity in Patients Following Laparoscopic Cholecystectomy: A Prospective, Randomized, Controlled, Double-Blind Non-Inferiority Trial Jung, Ki Tae So, Keum Young Kim, Seung Chul Kim, Sang Hun Medicina (Kaunas) Article Background and Objectives: We investigated the non-inferiority of patient-controlled analgesia (PCA), using either nefopam alone or combined nefopam-fentanyl for postoperative analgesia in patients undergoing laparoscopic cholecystectomy. Materials and Methods: In this prospective, randomized, controlled study, 78 patients were allocated to receive nefopam 240 mg (Group N240) or nefopam 120 mg with fentanyl 600 μg (Group NF), equivalent to fentanyl 1200 μg, with a total PCA volume of 120 mL. Patients were given a loading dose (0.1 mL/kg) from the PCA device along with ramosetron (0.3 mg) and connected to a PCA device with a background infusion rate of 2 mL/h, bolus dose amount set at 2 mL, and lockout interval set at 15 min. Pain scores were obtained using the numeric rating scale (NRS) at 30 min after recovery room (RR) admission, as well as 8 and 24 h postoperatively. The primary outcome was analgesic efficacy evaluated using NRS-rated 8 h postoperatively. Other evaluated outcomes included the incidence rate of bolus demand, rescue analgesic and antiemetic requirements, and postoperative adverse effects. Results: NRS scores were not significantly different between the groups throughout the postoperative period (p = 0.539). NRS scores of group N240 were not inferior to those of group NF at 30 min after RR admission, or at 8 and 24 h postoperatively (mean difference [95% CI], −0.05 [−0.73 to 0.63], 0.10 [−0.29 to 0.50], and 0.28 [−0.06 to 0.62], respectively). Postoperative adverse effects were not significantly different between the two groups (p = 1.000) and other outcomes were also not significantly different between the two groups (p ≥ 0.225). Conclusions: PCA using nefopam alone has a non-inferior and effective analgesic efficacy and produces a lower incidence of postoperative adverse effects compared to a combination of fentanyl and nefopam after laparoscopic cholecystectomy. MDPI 2021-03-27 /pmc/articles/PMC8067158/ /pubmed/33801705 http://dx.doi.org/10.3390/medicina57040316 Text en © 2021 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) ).
spellingShingle Article
Jung, Ki Tae
So, Keum Young
Kim, Seung Chul
Kim, Sang Hun
Effect of Nefopam-Based Patient-Controlled Analgesia with and without Fentanyl on Postoperative Pain Intensity in Patients Following Laparoscopic Cholecystectomy: A Prospective, Randomized, Controlled, Double-Blind Non-Inferiority Trial
title Effect of Nefopam-Based Patient-Controlled Analgesia with and without Fentanyl on Postoperative Pain Intensity in Patients Following Laparoscopic Cholecystectomy: A Prospective, Randomized, Controlled, Double-Blind Non-Inferiority Trial
title_full Effect of Nefopam-Based Patient-Controlled Analgesia with and without Fentanyl on Postoperative Pain Intensity in Patients Following Laparoscopic Cholecystectomy: A Prospective, Randomized, Controlled, Double-Blind Non-Inferiority Trial
title_fullStr Effect of Nefopam-Based Patient-Controlled Analgesia with and without Fentanyl on Postoperative Pain Intensity in Patients Following Laparoscopic Cholecystectomy: A Prospective, Randomized, Controlled, Double-Blind Non-Inferiority Trial
title_full_unstemmed Effect of Nefopam-Based Patient-Controlled Analgesia with and without Fentanyl on Postoperative Pain Intensity in Patients Following Laparoscopic Cholecystectomy: A Prospective, Randomized, Controlled, Double-Blind Non-Inferiority Trial
title_short Effect of Nefopam-Based Patient-Controlled Analgesia with and without Fentanyl on Postoperative Pain Intensity in Patients Following Laparoscopic Cholecystectomy: A Prospective, Randomized, Controlled, Double-Blind Non-Inferiority Trial
title_sort effect of nefopam-based patient-controlled analgesia with and without fentanyl on postoperative pain intensity in patients following laparoscopic cholecystectomy: a prospective, randomized, controlled, double-blind non-inferiority trial
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8067158/
https://www.ncbi.nlm.nih.gov/pubmed/33801705
http://dx.doi.org/10.3390/medicina57040316
work_keys_str_mv AT jungkitae effectofnefopambasedpatientcontrolledanalgesiawithandwithoutfentanylonpostoperativepainintensityinpatientsfollowinglaparoscopiccholecystectomyaprospectiverandomizedcontrolleddoubleblindnoninferioritytrial
AT sokeumyoung effectofnefopambasedpatientcontrolledanalgesiawithandwithoutfentanylonpostoperativepainintensityinpatientsfollowinglaparoscopiccholecystectomyaprospectiverandomizedcontrolleddoubleblindnoninferioritytrial
AT kimseungchul effectofnefopambasedpatientcontrolledanalgesiawithandwithoutfentanylonpostoperativepainintensityinpatientsfollowinglaparoscopiccholecystectomyaprospectiverandomizedcontrolleddoubleblindnoninferioritytrial
AT kimsanghun effectofnefopambasedpatientcontrolledanalgesiawithandwithoutfentanylonpostoperativepainintensityinpatientsfollowinglaparoscopiccholecystectomyaprospectiverandomizedcontrolleddoubleblindnoninferioritytrial