Continuous vs. Bolus Administration of NSAIDs After Laparoscopic Surgery for Multimodal Analgesia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ibuprofen continuous infusion, Ibuprofen bolus injection.
- Who it may be relevant to
- Registry conditions: Analgesic Drugs, Analgesic, Nonopioid, Analgesic Efficacy, Analgetic Consumption. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Russia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Continuous vs. Bolus Administration of NSAIDs After Laparoscopic Surgery for Multimodal Analgesia: Pilot Randomized Controlled Trial
Overview
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.
Interventions
- Drug Ibuprofen 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 infusi - Drug Ibuprofen 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 dilut
Primary outcome measures
- Opioid consumption [Time frame: up to 28 days]
Secondary outcome measures (1)
- Pain intensity assessment [Time frame: From admission to ICU until 48 hours postoperatively]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Russia · 1 center
- City Clinical Hospital named after S.S. Yudin — Moscow
Identifiers
NCT: NCT07070050 · CALM