The evaluation of the efficacy of etofenamate spray in postoperative cesarean pain: Randomized, double-blind, placebo-controlled trial

Objective: It was aimed to investigate the effect of etofenamate spray to be applied around the postoperative incision on pain control in cesarean section in this trial. Material and methods: This was a prospective, randomized, double-blind, and placebo-controlled trial. 187 patients (93 cases and 9...

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Main Authors: Kübra Bakİ Erİn, Recep Erİn, Safia Omar Sahal, Seyfi Kartal, Deniz Kulaksiz
Format: Article
Language:English
Published: Elsevier 2023-09-01
Series:Taiwanese Journal of Obstetrics & Gynecology
Subjects:
Online Access:http://www.sciencedirect.com/science/article/pii/S1028455923001833
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author Kübra Bakİ Erİn
Recep Erİn
Safia Omar Sahal
Seyfi Kartal
Deniz Kulaksiz
author_facet Kübra Bakİ Erİn
Recep Erİn
Safia Omar Sahal
Seyfi Kartal
Deniz Kulaksiz
author_sort Kübra Bakİ Erİn
collection DOAJ
description Objective: It was aimed to investigate the effect of etofenamate spray to be applied around the postoperative incision on pain control in cesarean section in this trial. Material and methods: This was a prospective, randomized, double-blind, and placebo-controlled trial. 187 patients (93 cases and 94 controls) were recruited for the study. In the trial group, we applied the etofenamate spray (Doline® 50 ml) after closing the cesarean skin incision and go on four times a day on the skin incision for 24 h. In the control group, we applied a placebo. All patients received paracetamol IV (Paracerol®) as standard analgesic doses. If analgesia was insufficient, tramadol (Contramal®) 50 mg IV doses were added and recorded. A visually analog pain scale (VAS) was performed on both groups at 6–12–18–24th hours. Independent t-tests were performed for data showing normal distributions. Results: There were no significant differences in the mean of differences VAS scores between the two groups at 6–12, and 6–18 h. However, a significant difference was obtained in the mean of differences VAS score at the 6-24th hour (p < 0.05). When the groups were compared in terms of additional paracetamol need, a significant difference was found again (p < 0.05). There was no significant difference between the groups in terms of tramadol need. Conclusion: Postoperative administration of etofenamate spray provided an analgesic effect at 24 h and additional analgesic usage decreased. Postoperative analgesia can also be used by administering NSAIDs around the cesarean section incision. In this way, the side effects of other systemic analgesics are avoided. Clinical trial id: PACTR201811864509898. Clinical trial web link: https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=5745.
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spelling doaj.art-a8899e9871704df7b37f1e58edf25d522023-09-07T04:43:03ZengElsevierTaiwanese Journal of Obstetrics & Gynecology1028-45592023-09-01625697701The evaluation of the efficacy of etofenamate spray in postoperative cesarean pain: Randomized, double-blind, placebo-controlled trialKübra Bakİ Erİn0Recep Erİn1Safia Omar Sahal2Seyfi Kartal3Deniz Kulaksiz4University of Health Sciences, Trabzon Kanuni Health Practice and Research Center, Department of Obstetrics and Gynecology, Trabzon, Turkey; Corresponding author. University of Health Sciences, Trabzon Kanuni Health Practice and Research Center, Trabzon, Turkey.University of Health Sciences, Trabzon Kanuni Health Practice and Research Center, Department of Obstetrics and Gynecology, Trabzon, Turkey; University of Health Sciences, Somalia Mogadishu Recep Tayyip Erdogan Health Practice and Research Center, Department of Obstetrics and Gynecology, Mogadishu, SomaliaUniversity of Health Sciences, Somalia Mogadishu Recep Tayyip Erdogan Health Practice and Research Center, Department of Obstetrics and Gynecology, Mogadishu, SomaliaUniversity of Health Sciences, Trabzon Kanuni Health Practice and Research Center, Department of Anesthesiology and Reanimation, Trabzon, TurkeyUniversity of Health Sciences, Trabzon Kanuni Health Practice and Research Center, Department of Obstetrics and Gynecology, Trabzon, Turkey; University of Health Sciences, Somalia Mogadishu Recep Tayyip Erdogan Health Practice and Research Center, Department of Obstetrics and Gynecology, Mogadishu, SomaliaObjective: It was aimed to investigate the effect of etofenamate spray to be applied around the postoperative incision on pain control in cesarean section in this trial. Material and methods: This was a prospective, randomized, double-blind, and placebo-controlled trial. 187 patients (93 cases and 94 controls) were recruited for the study. In the trial group, we applied the etofenamate spray (Doline® 50 ml) after closing the cesarean skin incision and go on four times a day on the skin incision for 24 h. In the control group, we applied a placebo. All patients received paracetamol IV (Paracerol®) as standard analgesic doses. If analgesia was insufficient, tramadol (Contramal®) 50 mg IV doses were added and recorded. A visually analog pain scale (VAS) was performed on both groups at 6–12–18–24th hours. Independent t-tests were performed for data showing normal distributions. Results: There were no significant differences in the mean of differences VAS scores between the two groups at 6–12, and 6–18 h. However, a significant difference was obtained in the mean of differences VAS score at the 6-24th hour (p < 0.05). When the groups were compared in terms of additional paracetamol need, a significant difference was found again (p < 0.05). There was no significant difference between the groups in terms of tramadol need. Conclusion: Postoperative administration of etofenamate spray provided an analgesic effect at 24 h and additional analgesic usage decreased. Postoperative analgesia can also be used by administering NSAIDs around the cesarean section incision. In this way, the side effects of other systemic analgesics are avoided. Clinical trial id: PACTR201811864509898. Clinical trial web link: https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=5745.http://www.sciencedirect.com/science/article/pii/S1028455923001833Cesarean sectionEtofenamateNSAIDsPostoperative analgesiaVisually numerical pain scale
spellingShingle Kübra Bakİ Erİn
Recep Erİn
Safia Omar Sahal
Seyfi Kartal
Deniz Kulaksiz
The evaluation of the efficacy of etofenamate spray in postoperative cesarean pain: Randomized, double-blind, placebo-controlled trial
Taiwanese Journal of Obstetrics & Gynecology
Cesarean section
Etofenamate
NSAIDs
Postoperative analgesia
Visually numerical pain scale
title The evaluation of the efficacy of etofenamate spray in postoperative cesarean pain: Randomized, double-blind, placebo-controlled trial
title_full The evaluation of the efficacy of etofenamate spray in postoperative cesarean pain: Randomized, double-blind, placebo-controlled trial
title_fullStr The evaluation of the efficacy of etofenamate spray in postoperative cesarean pain: Randomized, double-blind, placebo-controlled trial
title_full_unstemmed The evaluation of the efficacy of etofenamate spray in postoperative cesarean pain: Randomized, double-blind, placebo-controlled trial
title_short The evaluation of the efficacy of etofenamate spray in postoperative cesarean pain: Randomized, double-blind, placebo-controlled trial
title_sort evaluation of the efficacy of etofenamate spray in postoperative cesarean pain randomized double blind placebo controlled trial
topic Cesarean section
Etofenamate
NSAIDs
Postoperative analgesia
Visually numerical pain scale
url http://www.sciencedirect.com/science/article/pii/S1028455923001833
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