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Ibuprofen Use on Post-operative Pain Following Cholecystectomy

Ibuprofen Use on Post-operative Pain Following Cholecystectomy

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06478758
Enrollment
71
Registered
2024-06-27
Start date
2024-02-01
Completion date
2024-04-30
Last updated
2024-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Post-operative Pain

Keywords

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

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.

Interventions

DRUGIbuprofen 400 mg

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.

DRUGAcetaminophen 100 MG/ML

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.

Sponsors

Giresun University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Masking description

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.

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
VAS scores in the postoperative period24 hourPrimary 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.

Secondary

MeasureTime frameDescription
Opioid consumption and length of stay24 hourSecondary outcome was any decrease in opioid consumption and hospitalization.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026