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NCT Number: NCT07070050

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

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.

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Key information

Conditions

Analgesic Drugs Agnosia Analgesic Efficacy Analgesic, Nonopioid Analgetic Consumption Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Management Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Care Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

City Clinical Hospital named after S.S. Yudin

Moscow, Moscow Oblast, 115446, Russia

Location status: Recruiting

Location contact

Maria Shemetova, PhD

CONTACT

[email protected]

+79055617910

Maria Shemetova, PhD

PRINCIPAL_INVESTIGATOR

Natalia Smirnova

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ibuprofen continuous infusion

Drug
  • 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.
  • 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.
  • 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.

Ibuprofen bolus injection

Drug
  • 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.
  • 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).
  • 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.

Primary outcomes

  1. Opioid consumption

    Time frame: up to 28 days

    Evaluation of the overall consumption of opioid analgesics after surgery during the whole postoperative period

Secondary outcomes

  1. Pain intensity assessment

    Time frame: From admission to ICU until 48 hours postoperatively

    Evaluation of postoperative pain intensity using the Numerical Rating Scale (NRS); measurements at regular intervals and before rescue analgesia if pain exceeds NRS >5. The maximum value is 10, the minimum value is 0. The higher the value, the more severe patient's pain (worse).

Other outcomes

  1. NSAID-related Adverse Effects

    Time frame: up to 28 days

    Incidence and severity of adverse effects including respiratory depression, gastrointestinal dysfunction, hepatotoxicity, renal dysfunction, allergic reactions, and CNS effects.

  2. Length of ICU stay

    Time frame: 1 year

    The number of days between the day of discharge from the ICU (or in-hospital death) after initial admission and the day of randomization.

  3. Length of Hospital Stay

    Time frame: 1 year

    The number of days between the day of discharge from the hospital (or in-hospital death) after initial admission and the day of randomization.

  4. ICU Readmission

    Time frame: Within 28 days from randomization

    Incidence of readmission to the intensive care unit within 28 days from the day of randomization.

  5. In-hospital mortality

    Time frame: 1 year

    Number of patients who die from any cause during initial hospitalization

  6. 28-days mortality

    Time frame: From randomization to 28 days

    Number of patients who die from any cause within28 days after randomization

  7. 6-month mortality

    Time frame: From randomization to 6 months

    Number of patients who die from any cause within 6 months after randomization

Study contacts

Contact information is provided by the study sponsor or research team.

Kristina Kadantseva, PhD

CONTACT

[email protected]

+79168306947

Valery Likhvantsev, PhD

CONTACT

[email protected]

+79036235982

Sponsors and collaborators

Lead sponsor

Federal Research and Clinical Centre of Intensive Care Medicine and Rehabilitology

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 17, 2025
Registry last updated
Jul 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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