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

NCT07070050 | Recruiting Phase 4 DMC

• 1 other identifier: CALM
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

NSAID; pain management; analgesia; postoperative care; analgesic drug

Outcome Measures

Primary Outcomes (1)

• Opioid consumption

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

  up to 28 days

Secondary Outcomes (1)

• Pain intensity assessment

  From admission to ICU until 48 hours postoperatively

Other Outcomes (7)

• NSAID-related Adverse Effects

  up to 28 days

• Length of ICU stay

  1 year

• Length of Hospital Stay

  1 year

Study Arms (2)

NSAID bolus injection

ACTIVE COMPARATOR

Drug: Ibuprofen bolus injection

NSAID continuous infusion

EXPERIMENTAL

Drug: Ibuprofen continuous infusion

Interventions

Ibuprofen continuous infusion DRUG

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.

NSAID continuous infusion

Ibuprofen bolus injection DRUG

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.

NSAID bolus injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal Research and Clinical Centre of Intensive Care Medicine and Rehabilitology: lead

Study Sites (1)

City Clinical Hospital named after S.S. Yudin

Moscow, Moscow Oblast, 115446, Russia

RECRUITING

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Valery Likhvantsev, PhD

  Federal Research and Clinical Center of Intensive Care Medicine and Rehabilitology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Valery Likhvantsev, PhD

CONTACT

+79036235982; lik0704@gmail.com

Kristina Kadantseva, PhD

CONTACT

+79168306947; kristina161093@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2025
• First Posted: July 17, 2025
• Study Start: May 5, 2025
• Primary Completion (Estimated): May 20, 2026
• Study Completion (Estimated): November 20, 2026
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)