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

NCT ID: NCT07070050

Last Updated: 2025-07-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-05
• Study Completion Date: 2026-11-20

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

NSAID bolus injection

Group Type: ACTIVE_COMPARATOR

Ibuprofen bolus injection

Intervention Type: 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 continuous infusion

Group Type: EXPERIMENTAL

Ibuprofen continuous infusion

Intervention Type: 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.

Interventions

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 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.

Intervention Type: 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 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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal Research and Clinical Centre of Intensive Care Medicine and Rehabilitology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Valery Likhvantsev, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal Research and Clinical Center of Intensive Care Medicine and Rehabilitology

Locations

City Clinical Hospital named after S.S. Yudin

Moscow, Moscow Oblast, Russia

Site Status: RECRUITING

Countries

Russia

Central Contacts

Valery Likhvantsev, PhD

Role: CONTACT

lik0704@gmail.com

+79036235982

Kristina Kadantseva, PhD

Role: CONTACT

kristina161093@gmail.com

+79168306947

Facility Contacts

Maria Shemetova, PhD

Role: primary

mshemetova@mail.ru

+79055617910

Other Identifiers

CALM

Identifier Type: -

Identifier Source: org_study_id