Clinical trial NCT06478758: Ibuprofen Use on Post-operative Pain Following Cholecystectomy
Official title: Ibuprofen Use on Post-operative Pain Following Cholecystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Post-operative Pain
Keywords: intravenous ibuprofen
acetaminophen
laparoscopic cholecystectomy
postoperative pain control
analgesia
anti-inflammatory agents
Lead sponsor: Giresun University
Sponsor class: OTHER
First posted: 2024-06-27
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The present study included ASA grade I-II participants aged 18-65 years scheduled for laparoscopic cholecystectomy. Participants with a history of allergies or hypersensitivity to the aforementioned agents, renal, hepatic or gastrointestinal disease, significant cognitive impairment, recent use of long-term nonsteroid anti-inflammatory and opioids, oral anticoagulant use or known bleeding disorders, diabetes or any other neuropathic diseases and those who were pregnant or breastfeeding were excluded from the study.
Primary purpose: TREATMENT

Brief summary: In this study, the investigators compared the effects of IV forms of ibuprofen and acetaminophen on pain perception and opioid consumption following laparoscopic cholecystectomy. Participants in Group I (group ibuprofen, n=35) were administered 800 mg of IV ibuprofen; participants in Group A (group acetaminophen, n=36) were administered 1000 mg of IV acetaminophen.

Detailed description: Ibuprofen is a widely used NSAID that has antipyretic, analgesic, and anti-inflammatory effects. In this study, the investigators compared the effects of IV forms of ibuprofen and acetaminophen on pain perception and opioid consumption following laparoscopic cholecystectomy.The participants in this study were randomized into two groups. Participants in Group I (group ibuprofen, n=35) were administered 800 mg of IV ibuprofen; participants in Group A (group acetaminophen, n=36) were administered 1000 mg of IV acetaminophen. The investigators recorded demographic data including gender, age, ASA, BMI, duration of anesthesia and surgery, poNV, LOS, VAS scores and opioid consumption postoperatively.

Eligibility criteria: Inclusion Criteria:

* ASA grade I-II patients
* Aged 18-65 years

Exclusion Criteria:

* History of allergies or hypersensitivity to the aforementioned agents
* Renal, hepatic or gastrointestinal disease
* Significant cognitive impairment
* Recent use of long-term nonsteroid anti-inflammatory and opioids
* Oral anticoagulant use or known bleeding disorders
* Diabetes or any other neuropathic diseases
* Pregnancy or breastfeeding

Primary outcomes:
measure: VAS scores in the postoperative period
timeFrame: 24 hour
Secondary outcomes:
measure: Opioid consumption and length of stay
timeFrame: 24 hour
Other outcomes:
Locations:
city: Giresun
country: Turkey
facility: Giresun University
Study officials:
affiliation: Giresun University
name: Azime Bulut, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ahiskalioglu EO, Ahiskalioglu A, Aydin P, Yayik AM, Temiz A. Effects of single-dose preemptive intravenous ibuprofen on postoperative opioid consumption and acute pain after laparoscopic cholecystectomy. Medicine (Baltimore). 2017 Feb;96(8):e6200. doi: 10.1097/MD.0000000000006200.
citation: Ciftci B, Ekinci M, Celik EC, Kaciroglu A, Karakaya MA, Demiraran Y, Ozdenkaya Y. Comparison of Intravenous Ibuprofen and Paracetamol for Postoperative Pain Management after Laparoscopic Sleeve Gastrectomy. A Randomized Controlled Study. Obes Surg. 2019 Mar;29(3):765-770. doi: 10.1007/s11695-018-3613-1.
citation: Mohammadian Erdi A, Arabzadeh A, Isazadehfar K, Masoumzadeh M, Bahadoram M. Comparing the Efficacy and Side Effects of Intravenous Ibuprofen and Acetaminophen in Pain Control Following Laparoscopic Cholecystectomy. World J Plast Surg. 2022 Mar;11(1):117-124. doi: 10.52547/wjps.11.1.117.
citation: Celik EC, Kara D, Koc E, Yayik AM. The comparison of single-dose preemptive intravenous ibuprofen and paracetamol on postoperative pain scores and opioid consumption after open septorhinoplasty: a randomized controlled study. Eur Arch Otorhinolaryngol. 2018 Sep;275(9):2259-2263. doi: 10.1007/s00405-018-5065-6. Epub 2018 Jul 18.