Ibuprofen Use on Post-operative Pain Following Cholecystectomy

NCT06478758 | Completed Phase 4 DMC

• 1 other identifier: KAEK-230
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Post-operative Pain

Keywords

intravenous ibuprofen; acetaminophen; laparoscopic cholecystectomy; postoperative pain control; analgesia; anti-inflammatory agents

Outcome Measures

Primary Outcomes (1)

• VAS scores in the postoperative period

  Primary outcome was to reduce the VAS scores in the postoperative period. For this purpose the investigators recorded VAS scores at the 1, 2, 6, 12 and 24 h postoperatively.

  24 hour

Secondary Outcomes (1)

• Opioid consumption and length of stay

  24 hour

Study Arms (2)

Acetaminophen group

ACTIVE COMPARATOR

The acetaminophen group (n=35) received 1000 of mg acetaminophen intravenously in 100 mL saline at the end of the cholecystectomy.

Drug: Acetaminophen 100 MG/ML

Ibuprofen group

EXPERIMENTAL

The ibuprofen group (n=36) was administered 800 mg of ibuprofen at the end of the cholecystectomy.

Drug: Ibuprofen 400 mg

Interventions

Ibuprofen 400 mg DRUG

The ibuprofen group (n=36) was administered 800 mg of ibuprofen . All procedures were performed with the same team. During surgery, a 20% increase in the participant's heart rate and mean arterial pressure remifentanil infusion was administered. During the postoperative period, all participants continued to receive acetaminophen at 8-hour intervals, and tramadol was given to those with a visual analog score above 4. In the recovery room, the participants with a visual analog score of \> 4 were administered 100 mg of tramadol. All participants were prescribed acetaminophen every 8 hours postoperatively in whilst on the ward. Participants with a visual analog score of \> 4 received rescue analgesia with 100 mg of tramadol. Visual analog score and vital parameters were recorded at 1, 2, 6, 12 and 24 h postoperatively. The incidence of nausea and vomiting during the 24 h postoperative period was also recorded.

Ibuprofen group

Acetaminophen 100 MG/ML DRUG

The investigators administered 1000 mg of acetaminophen to the participants in Group A. A 20% increase in the participant's heart rate and mean arterial pressure was evaluated as pain and remifentanil infusion was administered. All participants continued to receive the routine application of acetaminophen at 8-hour intervals, and tramadol was given to those with a visual analog score above 4, postoperatively.In the recovery room, participants with a visual analog score of \> 4 were administered 100 mg of tramadol. All participants were prescribed acetaminophen every 8 hours postoperatively in whilst on the ward. Participants with a visual analog score of \> 4 received rescue analgesia with 100 mg of tramadol. Visual analog score and vital parameters were recorded at 1, 2, 6, 12 and 24 h postoperatively. The incidence of nausea and vomiting during the 24 h postoperative period was also recorded.

Acetaminophen group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Giresun University: lead

Study Sites (1)

Giresun University

Giresun, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 28225506 RESULT

• 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.

  PMID: 30474791 RESULT

• 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.

  PMID: 35592235 RESULT

• 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.

  PMID: 30022362 RESULT

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Interventions

Ibuprofen; Acetaminophen

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Study Officials

• Azime Bulut, MD

  Giresun University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Randomization of the participants was performed according to computer-generated random number tables, and allocation to a treatment group was performed using the envelope technique. For each participant taken the operating theater for laparoscopic cholecystectomy, an envelope was randomly selected and the code was recorded. The participants were unaware of which drug was being administered. The researcher who recorded the participants' demographic and follow-up data was also unaware of the type of drug being administered.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: June 27, 2024
• Study Start: February 1, 2024
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: June 27, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)