RecruitingPhase 4NCT07070050

Continuous vs. Bolus Administration of NSAIDs After Laparoscopic Surgery for Multimodal Analgesia

Continuous vs. Bolus Administration of NSAIDs After Laparoscopic Surgery for Multimodal Analgesia: Pilot Randomized Controlled Trial

Sponsor

Federal Research and Clinical Centre of Intensive Care Medicine and Rehabilitology

Enrollment

100 participants

Start Date

May 5, 2025

Study Type

INTERVENTIONAL

Conditions

Pain Management Postoperative Care Analgesic Drugs Analgesic, Nonopioid Analgesic Efficacy Analgetic Consumption

Summary

Currently the prevalent approach to perioperative management of patients is ERAS (Enhanced Recovery After Surgery) concept. This approach includes numerous aspects, among which the perioperative use of multimodal analgesia takes one of the leading places. Within the ERAS guidelines all sorts of minimization of opioid analgesics use in schemes of postoperative analgesia are appreciated. Thus, new pharmacological approaches are being actively developed currently in order to achieve adequate analgesia and to minimize the use of this group of drugs. One of the most perspective trends within the multimodal analgesia concept is continuous infusion of non-steroidal anti-inflammatory drugs (NSAID). Up to date there are papers that both confirm the effectiveness of this method for maintaining adequate postoperative analgesia and show its limitations and deny the advantages of the continuous use of NSAID. Up to this time the main attention of the medical community was paid for such drugs as paracetamol and ketoprofen. Nevertheless, one of the most common and safe NSAID is ibuprofen. In spite of this, there are no studies that explore the effectiveness of the continuous infusion of this drug. Thus, the lack of even low-quality evidence led to setting up a study of effectiveness and safety of continuous infusion of ibuprofen in comparison to its bolus injection.

Eligibility

Min Age: 18 Years

Inclusion Criteria5

Age \> 18 years old
Elective laparoscopic surgery
General anesthesia
Signed informed consent from the patient to participate in the study
RASS scale from -2 to +1 on admission to a surgical department or ICU

Exclusion Criteria8

History of ibuprofen allergy
Active erosive or ulcerative lesions of the gastrointestinal tract
Chronic use of opioid analgesics or NSAIDs prior to enrollment
Chronic kidney disease ≥ 3b stage according to the KDIGO classification
Liver dysfunction (three times exceeding the upper reference limit of ALT or AST)
A history of bronchial asthma
A history of hereditary coagulopathies
A history of use of anticoagulants

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Interventions

DRUGIbuprofen continuous infusion

1. The first bolus: ibuprofen 400 mg diluted in 0,9% NaCl 200 ml is intravenous injected during the first hour right after the admission to the department. The drug is injected during the first hour at the rate of 4 mg/kg/h for the ideal body weight. 2. Continuous infusion: * Ibuprofen 1200 mg diluted in 0,9% NaCl 300 ml is intravenous injected on the first day with the speed of 1 mg/kg/h (for the ideal body weight) during the remaining 23 hours. * On the second day the intravenous infusion of ibuprofen 1600 mg diluted in 0,9% NaCl 400 ml with the speed of 1 mg/kg/h is continued during the 24 hours. 3. Imitation of bolus: Every 8 hours placebo (0, 9% NaCl 200 ml) is intravenous injected to create an imitation of bolus injection. Placebo is injected during the first hour.

DRUGIbuprofen bolus injection

1. The first bolus: ibuprofen 400 mg diluted in 0, 9% NaCl 200 ml is intravenous injected during the first hour right after the admission to the department. The drug is injected during the first hour at the rate of 4 mg/kg/h for the ideal body weight. 2. Bolus injection: * Every 8 hours a intravenous bolus of ibuprofen 800 mg diluted in 0,9% NaCl 200 ml is injected during 1 hour (3 boluses per day in total). * On the second day the every 8 hours intravenous bolus of ibuprofen 800 mg diluted in 0, 9% NaCl 200 ml is injected during 1 hour (3 boluses per day in total). 3. Placebo continuous infusion: Between the boluses a placebo (0,9% NaCl) continuous intravenous infusion is performed with the speed imitating the speed of ibuprofen infusion in the experimental group.