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

Federal Research and Clinical Centre of Intensive Care Medicine and Rehabilitology

Status and phase

Enrolling

Phase 4

Conditions

Analgetic Consumption

Postoperative Care

Analgesic Efficacy

Pain Management

Analgesic Drugs

Analgesic, Nonopioid

Treatments

Drug: Ibuprofen bolus injection

Drug: Ibuprofen continuous infusion

Study type

Interventional

Funder types

Other

Identifiers

NCT07070050

CALM

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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