Analgesic DrugsPhase 4NCT07070050
Continuous vs. Bolus Administration of NSAIDs After Laparoscopic Surgery for Multimodal Analgesia
A Phase 4 study testing Ibuprofen continuous infusion and Ibuprofen bolus injection in people with Analgesic Drugs and Analgesic, Nonopioid, run by Federal Research and Clinical Centre of Intensive Care Medicine and Rehabilitology at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Analgesic Drugs, Analgesic, Nonopioid, Analgesic Efficacy
- What is being tested?
- Ibuprofen continuous infusion and Ibuprofen bolus injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteRussia
- Study dates
- 5 May 2025to 20 Nov 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
City Clinical Hospital named after S.S. Yudin
Moscow, Moscow Oblast, 115446
Maria Shemetova, PhD, +79055617910, mshemetova@mail.ru
Maria Shemetova, PhD
About this study
Official title: Continuous vs. Bolus Administration of NSAIDs After Laparoscopic Surgery for Multimodal Analgesia: Pilot Randomized Controlled Trial
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
- Being tested
- Ibuprofen continuous infusion, Ibuprofen bolus injection
- Keywords
- NSAID, pain management, analgesia, postoperative care, analgesic drug
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ibuprofen continuous infusionDrug
- 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 injectionDrug
- 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.
| Study group | Role | What they receive |
|---|---|---|
| NSAID bolus injection | Active comparator | Not described Receives: Drug: Ibuprofen bolus injection |
| NSAID continuous infusion | Experimental | Not described Receives: Drug: Ibuprofen continuous infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid consumption
Evaluation of the overall consumption of opioid analgesics after surgery during the whole postoperative period
Measured: up to 28 days
Secondary outcomes (1)
Pain intensity assessment
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).
Measured: From admission to ICU until 48 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start5 May 2025
- Primary completion20 May 2026 (estimated)
- Study completion20 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Analgesic DrugsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal Research and Clinical Centre of Intensive Care Medicine and Rehabilitology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valery Likhvantsev, PhD, Principal investigator, Federal Research and Clinical Center of Intensive Care Medicine and Rehabilitology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07070050
- Sponsor's protocol ID
- CALM
- Status last verified
- Jul 2025
- First submitted
- 30 Jun 2025
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous vs. Bolus Administration of NSAIDs After Laparoscopic Surgery for Multimodal Analgesia: Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07070050
- Acronym / sponsor ID
- CALM
- Conditions
- Analgesic Drugs, Analgesic, Nonopioid, Analgesic Efficacy, Analgetic Consumption, Postoperative Care, Pain Management
- Keywords
- NSAID, pain management, analgesia, postoperative care, analgesic drug
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Federal Research and Clinical Centre of Intensive Care Medicine and RehabilitologyUniversity, hospital or other
- Study start
- 5 May 2025 (actual)
- Primary completion
- 20 May 2026 (estimated)
- Study completion
- 20 Nov 2026 (estimated)
- First posted
- 17 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NSAID bolus injection | Active comparator | Drug: Ibuprofen bolus injection |
| NSAID continuous infusion | Experimental | Drug: Ibuprofen continuous infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ibuprofen continuous infusion1. 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. | Drug | NSAID continuous infusion |
| Ibuprofen bolus injection1. 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. | Drug | NSAID bolus injection |
Primary outcome
Opioid consumption
Time frame: up to 28 days
Evaluation of the overall consumption of opioid analgesics after surgery during the whole postoperative period
1 secondary outcome
Pain intensity assessment
Time frame: From admission to ICU until 48 hours postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Valery Likhvantsev, PhD principal investigator
Federal Research and Clinical Center of Intensive Care Medicine and Rehabilitology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ibuprofen continuous infusion and Ibuprofen bolus injection in people with Analgesic Drugs and Analgesic, Nonopioid, run by Federal Research and Clinical Centre of Intensive Care Medicine and Rehabilitology at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Valery Likhvantsev, PhD (+79036235982, lik0704@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid consumption (time frame: up to 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2025.