Heart SurgeryVR-USPNCT07063394
Evaluation of Virtual Reality for Reducing Opioid Use After Cardiac and Thoracic Surgery
A study testing Interactive Virtual Reality and Passive Virtual Reality in people with Heart Surgery and Thoracic Surgery, run by Filomena R B G Galas at 1 site in Brazil.
Trial summary
This clinical trial aims to evaluate the efficacy of virtual reality (VR) as an adjunctive therapeutic method to reduce opioid consumption during the postoperative period of cardiac and thoracic surgeries. Read more about this study
- Who is it for?
- Ages 16 to 40 years
- Conditions the study is for
- Heart Surgery, Thoracic Surgery, Opioid
- What is being tested?
- Interactive Virtual Reality and Passive Virtual Reality
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 10 Dec 2024to 30 Dec 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 16 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients undergoing elective cardiac or thoracic surgeries at the Heart Institute (InCor) of the Hospital das Clínicas of the University of São Paulo.
- Eligible thoracic surgeries include: pulmonary decortication, thoracic sympathectomy, video-assisted thoracoscopic surgery (VATS), pulmonary biopsy, and pectus excavatum repair using the Nuss procedure.
- Patients aged between 16 and 40 years.
- Preserved cognitive function, indicated by a Mini-Mental State Examination (MMSE) score of ≥ 25.
Who cannot join
- Visual impairments.
- Cognitive impairment (MMSE ≤ 24).
- Severe upper limb motor limitations.
- Claustrophobia.
- Spatial disorientation.
- Motion sickness or vestibular disorders.
- Infectious or contagious diseases.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Incor - Heart Institute - University of Sao Paulo
São Paulo, São Paulo, 05403000
Filomena B Galas, PhD, +55 11 99319-0441, filomenagalas@hotmail.com
About this study
Official title: Evaluation of the Efficacy of Virtual Reality as a Therapeutic Method to Reduce Opioid Consumption in Postoperative Cardiac and Thoracic Surgery
This clinical trial aims to evaluate the efficacy of virtual reality (VR) as an adjunctive therapeutic method to reduce opioid consumption during the postoperative period of cardiac and thoracic surgeries. Conducted at InCor/HCFMUSP, this single-center, prospective, randomized trial will include 60 patients aged 16 to 40 undergoing procedures such as valve replacements, pulmonary decortication, and video-assisted thoracic surgeries.
Patients will be randomized into three groups. The Interactive VR group receives standard anesthesia protocol combined with interactive VR therapy using games and immersive environments. The Passive VR group receives standard protocol combined with passive 360-degree immersive videos. The Control group receives standard anesthesia protocol without VR intervention. The intervention occurs in three daily sessions lasting 30-45 minutes each over the first five postoperative days or until hospital discharge.
Read more
The primary objective is to measure the reduction in total opioid consumption through medical prescriptions and patient-controlled analgesia (PCA) pump usage. Secondary objectives include pain intensity assessed by the Visual Analogue Scale (VAS), incidence of postoperative nausea and vomiting (PONV), duration of mechanical and non-invasive ventilation, length of stay in the ICU and hospital, occurrence of paralytic ileus, patient satisfaction, and cognitive status using the Mini-Mental State Examination (MMSE).
Opioids are standard for postoperative pain but are associated with adverse effects like respiratory depression. VR offers an innovative approach by creating immersive environments that serve as cognitive distractions to modulate pain perception and reduce anxiety. The study anticipates that VR will enhance pain control and improve recovery metrics, serving as a safe and scalable complement to traditional postoperative management.
Read the detailed description
Postoperative pain management in major cardiac and thoracic surgeries remains a significant clinical challenge due to the side-effect profile of opioids, including respiratory depression and dependency. This study explores Virtual Reality (VR) as a non-pharmacological adjunct based on the gate control theory and the concept of immersive distraction. By engaging multiple sensory faculties, VR aims to compete with nociceptive stimuli for limited attentional resources, thereby modulating pain perception and reducing the emotional component of the pain experience.
This clinical trial compares two distinct VR modalities to identify the most effective mechanism for pain modulation in a high-complexity surgical setting. The Interactive VR arm utilizes high-fidelity devices to engage patients in tasks requiring motor coordination and active cognitive processing, such as interactive gaming. This level of engagement is hypothesized to induce a deeper state of presence. The Passive VR arm focuses on contemplative, 360-degree immersive environments designed to induce physiological relaxation and calmness through visual immersion in tranquil natural settings.
The intervention protocol is standardized to begin on the first postoperative day at the Heart Institute (InCor). Each session is supervised by the research team to ensure proper equipment usage and to monitor for potential adverse effects, such as cybersickness or spatial disorientation. By comparing these immersive levels against a control group receiving standard institutional care, the study seeks to quantify the opioid-sparing effect of digital therapeutics. Statistical analysis will utilize multivariate models to identify associations between VR exposure and improved recovery indicators, providing evidence for the integration of VR into multimodal analgesia strategies.
- Conditions
- Heart Surgery, Thoracic Surgery, Opioid, Virtual Reality, Pain
- Being tested
- Interactive Virtual Reality, Passive Virtual Reality
- Keywords
- Heart surgery, Thoracic Surgery, Opioid, Virtual Reality, Pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interactive Virtual RealityDevice
Patients will utilize the Meta Quest 2 headset to engage in interactive applications requiring motor and cognitive tasks, such as Fruit Ninja 2 and Beat Saber, along with passive immersive software like Youtube VR. This dual approach combined with the institutional anesthesia protocol aims to maximize cognitive distraction. The intervention consists of three daily sessions of 30 to 45 minutes for five days postoperatively.
Passive Virtual RealityDevice
Patients in the Passive VR arm will receive standard anesthesia protocol combined with passive Virtual Reality (VR) therapy. This involves the use of a VR headset to watch immersive 360-degree videos, such as tranquil natural landscapes or underwater scenes, designed to promote relaxation and reduce anxiety. The VR sessions do not require active participation, allowing patients to passively observe calming environments. The intervention will be administered for 3 sessions per day, lasting 30-45 minutes each, over 5 consecutive postoperative days.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Interactive Virtual Reality | Experimental | Participants in Arm 1 will receive standard postoperative care plus virtual reality (VR) therapy using both interactive games and passive imagery. The goal is to reduce opioid consumption and improve recovery through immersive distraction. VR sessions will be held three times daily, lasting 30-45 minutes each, for five consecutive postoperative days or until discharge. Games such as Fruit Ninja 2, Beat Saber, and Oculus First Contact offer stimulating experiences, while passive content from YouTube VR provides relaxing visual environments. Patients will be trained to operate the VR device and choose content based on their preference. All sessions will be supervised by the study team to ensure proper use and maximize therapeutic effect. Receives: Device: Interactive Virtual Reality |
| Arm 2: Passive Virtual Reality | Experimental | Participants in Arm 2 will receive standard postoperative care plus virtual reality (VR) therapy focused solely on passive imagery for distraction. VR sessions will occur three times daily, each lasting 30-45 minutes, for five consecutive postoperative days or until discharge. Patients will view calming, immersive content-such as nature scenes and relaxing landscapes-available on platforms like YouTube VR. These experiences aim to reduce opioid consumption and improve recovery by decreasing pain perception. Participants will be trained to use the device and guided by the study team, who will supervise each session to ensure proper use and maximize therapeutic effect. Receives: Device: Passive Virtual Reality |
| Arm 3: Standard Postoperative Care (Control) | No intervention | Participants in Arm 3 will serve as the control group, receiving standard postoperative care without virtual reality (VR) intervention. Standard care includes institutional pain management protocols, such as the use of opioids and non-opioid analgesics after cardiac or thoracic surgery. No immersive or distraction-based technologies will be provided. This group serves as a baseline for comparison with the VR groups (Groups 1 and 2), enabling evaluation of the impact of VR on opioid consumption, pain perception, and recovery outcomes. Data from Group 3 will help assess the added value of VR as a complementary tool in postoperative care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Opioid Consumption
Measured by the total dose of opioids administered postoperatively, converted to Morphine Milligram Equivalents (MME), over the first 5 days.
Measured: From the end of surgery up to 5 days after surgery
Secondary outcomes (8)
Occurrence of Nausea and Vomiting
Frequency of postoperative nausea and vomiting episodes
Measured: Within 5 days after surgery
Length of ICU Stay
Number of days spent in the ICU
Measured: Within 5 days after surgery
Length of Hospital Stay
Number of days hospitalized
Measured: Within 30 days after surgery
Length of Mechanical Ventilation
Hours of mechanical ventilation
Measured: Within 5 days after surgery
Length of Non-Invasive Ventilation
Hours of non-invasive ventilation
Measured: Within 5 days after surgery
Occurrence of Paralytic Ileus
Presence of paralytic ileus postoperatively
Measured: Within 5 days after surgery
Patient Satisfaction
Patient satisfaction will be assessed using a Likert scale ranging from 1 to 5, where 1 indicates "very dissatisfied" and 5 indicates "very satisfied". Higher scores represent a better outcome (greater satisfaction).
Measured: Within 5 days after surgery
Postoperative Pain
Pain intensity will be measured using the Visual Analog Scale (VAS), which ranges from 0 to 10. A score of 0 represents "no pain" and 10 represents the "worst pain imaginable". Higher scores represent a worse outcome (greater pain intensity).
Measured: Within 5 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start10 Dec 2024
- Primary completion15 May 2026 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Heart SurgeryStudies 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
- Model description
- This is a prospective, randomized, single-center, parallel-group trial with three arms. Participants undergoing elective cardiac or thoracic surgery will be randomized in a 1:1:1 ratio to receive: (1) standard postoperative care plus virtual reality (VR) with interactive games and/or passive imagery; (2) standard care plus VR with passive contemplative imagery only; or (3) standard postoperative care alone (control). The VR intervention will be administered over five consecutive postoperative days, with three supervised sessions per day, each lasting 30 to 45 minutes.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Filomena R B G Galas
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Filomena R B G Galas, Instituto do Coracao
- Investigators
- Filomena Regina B. G. Galas, MD PhD, Principal investigator, Instituto do Coracao (InCor) - HCFMUSP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07063394
- Sponsor's protocol ID
- 6.889.108
- Other IDs
- 6.889.108
- Acronym
- VR-USP
- Status last verified
- Apr 2026
- First submitted
- 3 Jul 2025
- Last updated
- 15 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kodvavi MS, Asghar MA, Ghaffar RA, Nadeem I, Bhimani S, Kumari V, Rabbani A, Iqbal M, Naeem R, Nasir AM, Hassan SS, Ghazni MS. Effectiveness of virtual reality in managing pain and anxiety in adults during periprocedural period: a systematic review and meta-analysis. Langenbecks Arch Surg. 2023 Aug 9;408(1):301. doi: 10.1007/s00423-023-03046-5.
PubMed 37556082Lind A, Ahsan M, Totzeck M, Al-Rashid F, Haddad A, Dubler S, Brenner T, Skarabis A, El Gabry M, Rassaf T, Janosi RA. Virtual reality-assisted distraction during transcatheter aortic valve implantation under local anaesthesia: A randomised study. Int J Cardiol. 2023 Sep 15;387:131130. doi: 10.1016/j.ijcard.2023.131130. Epub 2023 Jun 22.
PubMed 37355243
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Virtual Reality as a Therapeutic Method to Reduce Opioid Consumption in Postoperative Cardiac and Thoracic Surgery
- ClinicalTrials.gov ID
- NCT07063394
- Acronym / sponsor ID
- VR-USP / 6.889.108
- Conditions
- Heart Surgery, Thoracic Surgery, Opioid, Virtual Reality, Pain
- Keywords
- Heart surgery, Thoracic Surgery, Opioid, Virtual Reality, Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Filomena R B G GalasOther government
- Study start
- 10 Dec 2024 (actual)
- Primary completion
- 15 May 2026 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 14 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.
This clinical trial aims to evaluate the efficacy of virtual reality (VR) as an adjunctive therapeutic method to reduce opioid consumption during the postoperative period of cardiac and thoracic surgeries. Conducted at InCor/HCFMUSP, this single-center, prospective, randomized trial will include 60 patients aged 16 to 40 undergoing procedures such as valve replacements, pulmonary decortication, and video-assisted thoracic surgeries.
Patients will be randomized into three groups. The Interactive VR group receives standard anesthesia protocol combined with interactive VR therapy using games and immersive environments. The Passive VR group receives standard protocol combined with passive 360-degree immersive videos. The Control group receives standard anesthesia protocol without VR intervention. The intervention occurs in three daily sessions lasting 30-45 minutes each over the first five postoperative days or until hospital discharge.
The primary objective is to measure the reduction in total opioid consumption through medical prescriptions and patient-controlled analgesia (PCA) pump usage. Secondary objectives include pain intensity assessed by the Visual Analogue Scale (VAS), incidence of postoperative nausea and vomiting (PONV), duration of mechanical and non-invasive ventilation, length of stay in the ICU and hospital, occurrence of paralytic ileus, patient satisfaction, and cognitive status using the Mini-Mental State Examination (MMSE).
Opioids are standard for postoperative pain but are associated with adverse effects like respiratory depression. VR offers an innovative approach by creating immersive environments that serve as cognitive distractions to modulate pain perception and reduce anxiety. The study anticipates that VR will enhance pain control and improve recovery metrics, serving as a safe and scalable complement to traditional postoperative management.
Detailed description
Postoperative pain management in major cardiac and thoracic surgeries remains a significant clinical challenge due to the side-effect profile of opioids, including respiratory depression and dependency. This study explores Virtual Reality (VR) as a non-pharmacological adjunct based on the gate control theory and the concept of immersive distraction. By engaging multiple sensory faculties, VR aims to compete with nociceptive stimuli for limited attentional resources, thereby modulating pain perception and reducing the emotional component of the pain experience.
This clinical trial compares two distinct VR modalities to identify the most effective mechanism for pain modulation in a high-complexity surgical setting. The Interactive VR arm utilizes high-fidelity devices to engage patients in tasks requiring motor coordination and active cognitive processing, such as interactive gaming. This level of engagement is hypothesized to induce a deeper state of presence. The Passive VR arm focuses on contemplative, 360-degree immersive environments designed to induce physiological relaxation and calmness through visual immersion in tranquil natural settings.
The intervention protocol is standardized to begin on the first postoperative day at the Heart Institute (InCor). Each session is supervised by the research team to ensure proper equipment usage and to monitor for potential adverse effects, such as cybersickness or spatial disorientation. By comparing these immersive levels against a control group receiving standard institutional care, the study seeks to quantify the opioid-sparing effect of digital therapeutics. Statistical analysis will utilize multivariate models to identify associations between VR exposure and improved recovery indicators, providing evidence for the integration of VR into multimodal analgesia strategies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This is a prospective, randomized, single-center, parallel-group trial with three arms. Participants undergoing elective cardiac or thoracic surgery will be randomized in a 1:1:1 ratio to receive: (1) standard postoperative care plus virtual reality (VR) with interactive games and/or passive imagery; (2) standard care plus VR with passive contemplative imagery only; or (3) standard postoperative care alone (control). The VR intervention will be administered over five consecutive postoperative days, with three supervised sessions per day, each lasting 30 to 45 minutes.
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Interactive Virtual Reality | Experimental | Device: Interactive Virtual RealityParticipants in Arm 1 will receive standard postoperative care plus virtual reality (VR) therapy using both interactive games and passive imagery. The goal is to reduce opioid consumption and improve recovery through immersive distraction. VR sessions will be held three times daily, lasting 30-45 minutes each, for five consecutive postoperative days or until discharge. Games such as Fruit Ninja 2, Beat Saber, and Oculus First Contact offer stimulating experiences, while passive content from YouTube VR provides relaxing visual environments. Patients will be trained to operate the VR device and choose content based on their preference. All sessions will be supervised by the study team to ensure proper use and maximize therapeutic effect. |
| Arm 2: Passive Virtual Reality | Experimental | Device: Passive Virtual RealityParticipants in Arm 2 will receive standard postoperative care plus virtual reality (VR) therapy focused solely on passive imagery for distraction. VR sessions will occur three times daily, each lasting 30-45 minutes, for five consecutive postoperative days or until discharge. Patients will view calming, immersive content-such as nature scenes and relaxing landscapes-available on platforms like YouTube VR. These experiences aim to reduce opioid consumption and improve recovery by decreasing pain perception. Participants will be trained to use the device and guided by the study team, who will supervise each session to ensure proper use and maximize therapeutic effect. |
| Arm 3: Standard Postoperative Care (Control) | No intervention | –Participants in Arm 3 will serve as the control group, receiving standard postoperative care without virtual reality (VR) intervention. Standard care includes institutional pain management protocols, such as the use of opioids and non-opioid analgesics after cardiac or thoracic surgery. No immersive or distraction-based technologies will be provided. This group serves as a baseline for comparison with the VR groups (Groups 1 and 2), enabling evaluation of the impact of VR on opioid consumption, pain perception, and recovery outcomes. Data from Group 3 will help assess the added value of VR as a complementary tool in postoperative care. |
Who may qualify
- Ages
- 16 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Patients undergoing elective cardiac or thoracic surgeries at the Heart Institute (InCor) of the Hospital das Clínicas of the University of São Paulo.
- Eligible thoracic surgeries include: pulmonary decortication, thoracic sympathectomy, video-assisted thoracoscopic surgery (VATS), pulmonary biopsy, and pectus excavatum repair using the Nuss procedure.
- Patients aged between 16 and 40 years.
- Preserved cognitive function, indicated by a Mini-Mental State Examination (MMSE) score of ≥ 25.
Key exclusion criteria (7 listed)
- Visual impairments.
- Cognitive impairment (MMSE ≤ 24).
- Severe upper limb motor limitations.
- Claustrophobia.
- Spatial disorientation.
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 |
|---|---|---|
| Interactive Virtual RealityPatients will utilize the Meta Quest 2 headset to engage in interactive applications requiring motor and cognitive tasks, such as Fruit Ninja 2 and Beat Saber, along with passive immersive software like Youtube VR. This dual approach combined with the institutional anesthesia protocol aims to maximize cognitive distraction. The intervention consists of three daily sessions of 30 to 45 minutes for five days postoperatively. | Device | Arm 1: Interactive Virtual Reality |
| Passive Virtual RealityPatients in the Passive VR arm will receive standard anesthesia protocol combined with passive Virtual Reality (VR) therapy. This involves the use of a VR headset to watch immersive 360-degree videos, such as tranquil natural landscapes or underwater scenes, designed to promote relaxation and reduce anxiety. The VR sessions do not require active participation, allowing patients to passively observe calming environments. The intervention will be administered for 3 sessions per day, lasting 30-45 minutes each, over 5 consecutive postoperative days. | Device | Arm 2: Passive Virtual Reality |
Primary outcome
Reduction in Opioid Consumption
Time frame: From the end of surgery up to 5 days after surgery
Measured by the total dose of opioids administered postoperatively, converted to Morphine Milligram Equivalents (MME), over the first 5 days.
8 secondary outcomes
Occurrence of Nausea and Vomiting
Time frame: Within 5 days after surgery
Length of ICU Stay
Time frame: Within 5 days after surgery
Length of Hospital Stay
Time frame: Within 30 days after surgery
Length of Mechanical Ventilation
Time frame: Within 5 days after surgery
Length of Non-Invasive Ventilation
Time frame: Within 5 days after surgery
Occurrence of Paralytic Ileus
Time frame: Within 5 days after surgery
Patient Satisfaction
Time frame: Within 5 days after surgery
Postoperative Pain
Time frame: Within 5 days after surgery
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 15 Apr 2026.
- Results publication: PubMed 37556082Kodvavi MS, Asghar MA, Ghaffar RA, Nadeem I, Bhimani S, Kumari V, Rabbani A, Iqbal M, Naeem R, Nasir AM, Hassan SS, Ghazni MS. Effectiveness of virtual reality in managing pain and anxiety in adults during periprocedural period: a systematic review and meta-analysis. Langenbecks Arch Surg. 2023 Aug 9;408(1):301. doi: 10.1007/s00423-023-03046-5.
- Results publication: PubMed 37355243Lind A, Ahsan M, Totzeck M, Al-Rashid F, Haddad A, Dubler S, Brenner T, Skarabis A, El Gabry M, Rassaf T, Janosi RA. Virtual reality-assisted distraction during transcatheter aortic valve implantation under local anaesthesia: A randomised study. Int J Cardiol. 2023 Sep 15;387:131130. doi: 10.1016/j.ijcard.2023.131130. Epub 2023 Jun 22.
- 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.
Filomena Regina B. G. Galas, MD PhD principal investigator
Instituto do Coracao (InCor) - HCFMUSP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interactive Virtual Reality and Passive Virtual Reality in people with Heart Surgery and Thoracic Surgery, run by Filomena R B G Galas at 1 site in Brazil.
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 4 inclusion and 7 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 15 Apr 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 Brazil. 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 Filomena Regina B Galas, PhD (+55 11 99319-0441, filomenagalas@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in Opioid Consumption (time frame: From the end of surgery up to 5 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07063394, which also lists 2 linked publications.
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 15 Apr 2026.