Posoperativ PainOFPAINS-CSNCT07618130
Opioid-Free Anesthesia and Pain Study in Cardiac Surgery Patients
A study testing Opioid Free Anaesthesia and Opioid Anesthesia in people with Posoperativ Pain and Chronich Pain, run by Clinical Centre of Serbia at 1 site in Serbia.
Trial summary
The goal of this clinical trial is to compare the effect of opioid-free anesthesia on the intensity of acute and chronic postoperative pain in patients undergoing cardiac surgery. The study will also evaluate the safety of opioid-free anesthesia in this patient population. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Posoperativ Pain, Chronich Pain, Postoperativ Delirum
- What is being tested?
- Opioid Free Anaesthesia and Opioid Anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteSerbia
- Study dates
- 1 Jul 2026to 20 Nov 2027
- Phase
- Interventional
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- elective cardiac surgery patients
Who cannot join
- Emergecy cardiac surgery patients
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Assessment od the Effects of Opioid-Free Anesthesia on Acute and Chronich Postsurgical Pain in Cardiac Surgery Patinets: A Prospective Randomized Controlled Trial
The goal of this clinical trial is to compare the effect of opioid-free anesthesia on the intensity of acute and chronic postoperative pain in patients undergoing cardiac surgery. The study will also evaluate the safety of opioid-free anesthesia in this patient population.
The main questions it aims to answer are:
Read more
- Is opioid-free anesthesia effective in reducing the intensity of acute and chronic postoperative pain in cardiac surgery patients?
- Is this anesthetic technique safe in this patient population? Patients will be randomized before surgery into two groups. In the first group, anesthesia will be performed with opioids, while in the second group, anesthesia will be performed without opioids. Researchers will measure acute postoperative pain during the first 48 hours using the Numeric Rating Pain Scale (NRPS). Chronic postoperative pain will be assessed after 3 months via a telephone interview.
Additionally, the incidence of adverse events-including postoperative delirium (POD), hemodynamic instability, respiratory complications, constipation, and postoperative nausea and vomiting (PONV)-as well as overall treatment outcomes, will be evaluated.
- Being tested
- Opioid Free Anaesthesia, Opioid Anesthesia
- Keywords
- OPIOPID-FREE, ANESTHESIA, CARDIAC SURGERY, ACUT PAIN, CHRONICH PAIN, POD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opioid Free AnaesthesiaProcedure or surgery
Also called Opioid-free, Anesthesia
Anesthesia will consist of a multimodal combination of general non-opioid agents (propofol, dexmedetomidine, midazolam, sevoflurane, and esketamine) supplemented by regional anesthesia techniques, including the erector spinae plane block (ESPB), serratus anterior plane block, and parasternal block.
Opioid AnesthesiaProcedure or surgery
Also called sufentanil
This will include intraoperative opioids (e.g., fentanyl or sufentanil) in combination with general anesthetic agents such as propofol, sevoflurane, and midazolam, supplemented by additional analgesics as required. Regional anesthesia techniques (e.g., erector spinae plane block, serratus anterior plane block, or parasternal block) may also be performed at the discretion of the attending anesthesiologist
| Study group | Role | What they receive |
|---|---|---|
| Opioid-Free Anesthesia Groupe | Experimental | Patients in the opioid-free group will receive anesthesia without any opioids. Receives: Procedure: Opioid Free Anaesthesia |
| Opioid anesthesia groupe | Active comparator | In the opioid group, patients will receive conventional opioid-based anesthesia. Receives: Procedure: Opioid Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute postoperativ pain
Postoperative pain will be assessed using the Numeric Rating Pain Scale (NRPS/NRS 0-10) after cardiac surgery
Measured: Assessments will be performed upon extubation (T0) and then every 12 hours for the first 48 postoperative hours (at 12, 24, 36, and 48 hours).
Chronich postoperative pain
Assessed using NRS (0-10) for average and worst pain intensity. Analgesic medication use (type and dose) related to the surgery will also be recorded at this time point.
Measured: Chronic postoperative pain will be assessed 3 months after cardiac surgery. Patients will be contacted by phone
Secondary outcomes (1)
Incidency of potsoperativ delirium
The occurrence of postoperative delirium will be monitored using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU). The incidence of delirium is defined as at least one positive C
Measured: Screening will begin after extubation and will be performed twice daily (once in the morning and once in the evening) for the first 5 postoperative days or until discharge from the hospital.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion20 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posoperativ PainStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinical Centre of Serbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dejan Markovic, Clinical Centre of Serbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07618130
- Sponsor's protocol ID
- 95/20
- Acronym
- OFPAINS-CS
- Status last verified
- May 2026
- First submitted
- 24 May 2026
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment od the Effects of Opioid-Free Anesthesia on Acute and Chronich Postsurgical Pain in Cardiac Surgery Patinets: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07618130
- Acronym / sponsor ID
- OFPAINS-CS / 95/20
- Keywords
- OPIOPID-FREE, ANESTHESIA, CARDIAC SURGERY, ACUT PAIN, CHRONICH PAIN, POD
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Clinical Centre of SerbiaUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 20 Nov 2027 (estimated)
- First posted
- 1 Jun 2026 (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.
The goal of this clinical trial is to compare the effect of opioid-free anesthesia on the intensity of acute and chronic postoperative pain in patients undergoing cardiac surgery. The study will also evaluate the safety of opioid-free anesthesia in this patient population.
The main questions it aims to answer are:
- Is opioid-free anesthesia effective in reducing the intensity of acute and chronic postoperative pain in cardiac surgery patients?
- Is this anesthetic technique safe in this patient population? Patients will be randomized before surgery into two groups. In the first group, anesthesia will be performed with opioids, while in the second group, anesthesia will be performed without opioids. Researchers will measure acute postoperative pain during the first 48 hours using the Numeric Rating Pain Scale (NRPS). Chronic postoperative pain will be assessed after 3 months via a telephone interview.
Additionally, the incidence of adverse events-including postoperative delirium (POD), hemodynamic instability, respiratory complications, constipation, and postoperative nausea and vomiting (PONV)-as well as overall treatment outcomes, will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Opioid-Free Anesthesia Groupe | Experimental | Procedure: Opioid Free AnaesthesiaPatients in the opioid-free group will receive anesthesia without any opioids. |
| Opioid anesthesia groupe | Active comparator | Procedure: Opioid AnesthesiaIn the opioid group, patients will receive conventional opioid-based anesthesia. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- elective cardiac surgery patients
Key exclusion criteria (1 listed)
- Emergecy cardiac surgery patients
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 |
|---|---|---|
| Opioid Free AnaesthesiaAlso: Opioid-free, AnesthesiaAnesthesia will consist of a multimodal combination of general non-opioid agents (propofol, dexmedetomidine, midazolam, sevoflurane, and esketamine) supplemented by regional anesthesia techniques, including the erector spinae plane block (ESPB), serratus anterior plane block, and parasternal block. | Procedure or surgery | Opioid-Free Anesthesia Groupe |
| Opioid AnesthesiaAlso: sufentanilThis will include intraoperative opioids (e.g., fentanyl or sufentanil) in combination with general anesthetic agents such as propofol, sevoflurane, and midazolam, supplemented by additional analgesics as required. Regional anesthesia techniques (e.g., erector spinae plane block, serratus anterior plane block, or parasternal block) may also be performed at the discretion of the attending anesthesiologist | Procedure or surgery | Opioid anesthesia groupe |
Primary outcome
Acute postoperativ pain
Time frame: Assessments will be performed upon extubation (T0) and then every 12 hours for the first 48 postoperative hours (at 12, 24, 36, and 48 hours).
Postoperative pain will be assessed using the Numeric Rating Pain Scale (NRPS/NRS 0-10) after cardiac surgery
Chronich postoperative pain
Time frame: Chronic postoperative pain will be assessed 3 months after cardiac surgery. Patients will be contacted by phone
Assessed using NRS (0-10) for average and worst pain intensity. Analgesic medication use (type and dose) related to the surgery will also be recorded at this time point.
1 secondary outcome
Incidency of potsoperativ delirium
Time frame: Screening will begin after extubation and will be performed twice daily (once in the morning and once in the evening) for the first 5 postoperative days or until discharge from the hospital.
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 1 Jun 2026.
- Individual participant dataSharing planned: Undecided
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Opioid Free Anaesthesia and Opioid Anesthesia in people with Posoperativ Pain and Chronich Pain, run by Clinical Centre of Serbia at 1 site in Serbia.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 1 Jun 2026. 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 Serbia. 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.
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 Dejan Markovic, MD, PhD, Associated Professor (+381668300903, drdejanmarkovic@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute postoperativ pain (time frame: Assessments will be performed upon extubation (T0) and then every 12 hours for the first 48 postoperative hours (at 12, 24, 36, and 48 hours).). The study lists 2 primary outcomes in all. 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 1 Jun 2026.