Postoperative PainNCT07763249
Comparison of Paravertebral Versus Epidural Block for Post-thoracotomy Pain Control
A study testing Continuous Thoracic Paravertebral Block and Continuous Thoracic Epidural Block in people with Postoperative Pain, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
This is a randomized, assessor-blinded, non-inferiority clinical trial comparing continuous thoracic paravertebral block (BPV) versus continuous thoracic epidural block (BPD) for postoperative pain control in adult patients undergoing elective open thoracotomy with one-lung ventilation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Continuous Thoracic Paravertebral Block and Continuous Thoracic Epidural Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Sep 2026to 31 Jul 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 years or older;
- Elective thoracic surgeries requiring open thoracotomy;
- American Society of Anesthesiologists (ASA) physical status I to III.
Who cannot join
- Pregnancy or lactation;
- Urgent or emergency surgeries;
- Contraindications to epidural catheter insertion or neuraxial anesthesia;
- Infection at the proposed block site;
- Patient refusal to undergo the study blocks;
- Video-assisted thoracic surgeries;
Show all 13Show fewer
- Anticipated need for invasive mechanical ventilation in the postoperative period;
- Chronic opioid use (daily use for more than 3 months of ≥10 mg oral morphine equivalent);
- Severe vertebral deformities or previous thoracic spine surgery that prevent safe performance of the blocks;
- Known allergy to local anesthetics, opioids, or study medications;
- Body mass index > 35 kg/m²;
- Advanced liver or kidney failure (Child-Pugh C or estimated glomerular filtration rate < 50 mL/min/1.73 m²);
- Severe cognitive impairment that prevents understanding of instructions or pain assessment.
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
Hospital de Clínicas de Porto Alegre (HCPA)
Porto Alegre, Rio Grande Do Sul (RS), 90410-000
Cristiano F Andrade, MD, PhD, +55513359-6246, cfandrade@hcpa.edu.br
About this study
Official title: Comparison Between Paravertebral Block and Epidural Block for the Management of Postoperative Pain in Patients Undergoing Thoracotomy and One-Lung Ventilation: A Prospective Non-inferiority Study.
This is a randomized, assessor-blinded, non-inferiority clinical trial comparing continuous thoracic paravertebral block (BPV) versus continuous thoracic epidural block (BPD) for postoperative pain control in adult patients undergoing elective open thoracotomy with one-lung ventilation. The primary outcome is the mean pain intensity at rest assessed by the Numeric Verbal Scale (NVS 0-10) during the first 48 hours after surgery. A total of 80 participants will be randomized 1:1 at Hospital de Clínicas de Porto Alegre, Brazil. The study aims to determine whether BPV provides non-inferior analgesia compared to BPD, with a potential advantage of less hemodynamic interference and better postoperative mobilization.
Read the detailed description
This is a randomized, assessor-blinded, non-inferiority clinical trial conducted at Hospital de Clínicas de Porto Alegre, Brazil, in adult patients undergoing elective open thoracotomy with one-lung ventilation. The objective is to compare the analgesic efficacy of continuous thoracic paravertebral block (BPV) versus continuous thoracic epidural block (BPD) for postoperative pain control during the first 48 hours after surgery.
Patients will be randomly allocated to two groups (40 per group). In the BPV group, the paravertebral catheter is inserted at the end of surgery under direct thoracoscopic vision (without ultrasound), using a bolus of ropivacaine 0.375% (15 mL fractionated) followed by continuous infusion of bupivacaine 0.125% at 0.10 mL/kg/h. In the BPD group, the epidural catheter is inserted at the beginning of surgery using the loss-of-resistance technique with the same bolus and infusion regimen. The target dermatomal level is T5-T7 (or T5-T9).
The primary outcome is the mean pain score at rest measured by the Numeric Verbal Scale (NVS 0-10) at 6, 12, 24, and 48 hours postoperatively. Secondary outcomes include pain on movement, total opioid consumption (converted to morphine equivalents), block-related complications (hypotension, urinary retention, technical failure, motor block), clinically significant pulmonary and cardiovascular complications, length of hospital stay, and patient satisfaction with analgesia.
Randomization is centralized using variable block sizes and sealed numbered envelopes. Outcome assessors are blinded to allocation. Both groups receive identical multimodal analgesia and a standardized rescue protocol. The sample size of 80 participants was calculated to demonstrate non-inferiority with a margin of 1 point on the NVS (expected SD = 1.5; 80% power; one-sided α = 0.025).
The study was approved by the Research Ethics Committee of HCPA (Opinion No. 8.544.882; CAAE 98467026.8.0000.5327) and will be conducted in accordance with the Declaration of Helsinki and current Brazilian regulations.
- Conditions
- Postoperative Pain
- Being tested
- Continuous Thoracic Paravertebral Block, Continuous Thoracic Epidural Block
- Keywords
- Postoperative Pain, Thoracotomy, Acute Pain, Thoracic Surgery, Regional Anesthesia
- Medical subject headings
- Pain, Postoperative, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Thoracic Paravertebral BlockProcedure or surgery
Participants randomized to the continuous thoracic paravertebral block (BPV) group. At the end of surgery and before chest tube placement, a paravertebral catheter is inserted under direct thoracoscopic vision (without ultrasound) using a Tuohy needle. A bolus of ropivacaine 0.375% (15 mL, fractionated) is administered, followed by continuous infusion of bupivacaine 0.125% at 0.10 mL/kg/h. The target level is T5-T7 (or T5-T9). The catheter remains in place for at least 48 hours postoperatively.
Continuous Thoracic Epidural BlockProcedure or surgery
Participants randomized to the continuous thoracic epidural block (BPD) group. At the beginning of surgery, an epidural catheter is inserted at the thoracic level using the loss-of-resistance technique. A bolus of ropivacaine 0.375% (15 mL, fractionated) is administered, followed by continuous infusion of bupivacaine 0.125% at 0.10 mL/kg/h. The target level is T5-T7 (or T5-T9). The catheter remains in place for at least 48 hours postoperatively.
| Study group | Role | What they receive |
|---|---|---|
| Paravertebral Block Group | Experimental | Participants randomized to the continuous thoracic paravertebral block (BPV) group. At the end of surgery and before chest tube placement, a paravertebral catheter is inserted under direct thoracoscopic vision (without ultrasound) using a Tuohy needle. A bolus of ropivacaine 0.375% (15 mL, fractionated) is administered, followed by continuous infusion of bupivacaine 0.125% at 0.10 mL/kg/h. The target level is T5-T7 (or T5-T9). The catheter remains in place for at least 48 hours postoperatively. Receives: Procedure: Continuous Thoracic Paravertebral Block |
| Epidural Block Group | Active comparator | Participants randomized to the continuous thoracic epidural block (BPD) group. At the beginning of surgery, an epidural catheter is inserted at the thoracic level using the loss-of-resistance technique. A bolus of ropivacaine 0.375% (15 mL, fractionated) is administered, followed by continuous infusion of bupivacaine 0.125% at 0.10 mL/kg/h. The target level is T5-T7 (or T5-T9). The catheter remains in place for at least 48 hours postoperatively. Receives: Procedure: Continuous Thoracic Epidural Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean pain intensity at rest during the first 48 hours after surgery
Mean of the pain scores at rest measured by the Numeric Verbal Scale (NVS 0-10) at 6, 12, 24, and 48 hours postoperatively. This composite measure is the primary endpoint for the non-inferiority comparison between continuous thoracic paravertebral block and continuous thoracic epidural block.
Measured: 6, 12, 24, and 48 hours after surgery
Secondary outcomes (6)
Pain on movement
Pain intensity during movement (e.g., coughing, sitting, or walking) assessed by Numeric Verbal Scale (0-10) at 6, 12, 24, and 48 hours postoperatively.
Measured: 6, 12, 24, and 48 hours after surgery
Total opioid consumption in the first 48 hours
Total opioid consumption (converted to intravenous morphine equivalents in mg) from the end of surgery until 48 hours postoperatively.
Measured: 0 to 48 hours after surgery
Block-related complications
Incidence of complications related to the regional blocks, including hypotension (systolic BP < 100 mmHg or >20% drop from baseline), urinary retention requiring catheterization, motor block (modified Bromage scale), and technical failure of the block.
Measured: During the first 48 hours after surgery
Clinically significant pulmonary and cardiovascular complications
Incidence of clinically significant pulmonary complications (e.g., atelectasis requiring intervention, pneumonia) and cardiovascular complications (e.g., arrhythmias requiring treatment, ischemic events) in the first 72 hours after surgery.
Measured: Up to 72 hours after surgery
Length of hospital stay
Total number of days from surgery until hospital discharge.
Measured: From surgery until hospital discharge (assessed up to 30 days)
Patient satisfaction with analgesia
Patient satisfaction with postoperative pain control assessed by a 5-point Likert scale (1 = very dissatisfied to 5 = very satisfied) at 48 hours after surgery.
Measured: 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- 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 two-arm, parallel-group, randomized controlled non-inferiority trial. Participants are randomly assigned in a 1:1 ratio to either the continuous thoracic paravertebral block group (BPV) or the continuous thoracic epidural block group (BPD). Both groups receive catheter-based regional analgesia using the same initial bolus (ropivacaine 0.375%, 15 mL) and continuous infusion (bupivacaine 0.125% at 0.10 mL/kg/h). The parallel design allows direct head-to-head comparison of the two techniques for non-inferiority in postoperative pain control during the first 48 hours, with blinded outcome assessment.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cristiano F Andrade, MD, PhD, Principal investigator, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07763249
- Sponsor's protocol ID
- 98467026.8.0000.5327
- Other IDs
- 2026-0110
- Status last verified
- Aug 2026
- First submitted
- 10 Aug 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers. Only aggregated and de-identified results will be published. All data will be stored securely and confidentially in accordance with institutional policies and Brazilian data protection laws (LGPD).
Publications
Perumal-Pillay VA, Suleman F. Selection of essential medicines for South Africa - an analysis of in-depth interviews with national essential medicines list committee members. BMC Health Serv Res. 2017 Jan 7;17(1):17. doi: 10.1186/s12913-016-1946-9.
PubMed 28061899Talmor D, Merkind V, Artru AA, Shapiro O, Geva D, Roytblat L, Shapira Y. Treatments to support blood pressure increases bleeding and/or decreases survival in a rat model of closed head trauma combined with uncontrolled hemorrhage. Anesth Analg. 1999 Oct;89(4):950-6. doi: 10.1097/00000539-199910000-00024.
PubMed 10512270Gupta T, Gupta SK, Sahni D. Anatomy of the tentorial segment of the trochlear nerve in reference to its preservation during surgery for skull base lesions. Surg Radiol Anat. 2014 Dec;36(10):967-71. doi: 10.1007/s00276-014-1278-6. Epub 2014 Mar 13.
PubMed 24623122Weitzel NS. Anesthesia and airway surgery. Semin Cardiothorac Vasc Anesth. 2012 Dec;16(4):181. doi: 10.1177/1089253212465019. No abstract available.
PubMed 23235989Bard RL, Gillespie BW, Patel H, Nicklas JM. Prognostic ability of resting periodic breathing and ventilatory variation in closely matched patients with heart failure. J Cardiopulm Rehabil Prev. 2008 Sep-Oct;28(5):318-22. doi: 10.1097/01.HCR.0000336143.02064.0e.
PubMed 18784542
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Paravertebral Block and Epidural Block for the Management of Postoperative Pain in Patients Undergoing Thoracotomy and One-Lung Ventilation: A Prospective Non-inferiority Study.
- ClinicalTrials.gov ID
- NCT07763249
- Acronym / sponsor ID
- 98467026.8.0000.5327
- Conditions
- Postoperative Pain
- Keywords
- Postoperative Pain, Thoracotomy, Acute Pain, Thoracic Surgery, Regional Anesthesia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 13 Aug 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.
This is a randomized, assessor-blinded, non-inferiority clinical trial comparing continuous thoracic paravertebral block (BPV) versus continuous thoracic epidural block (BPD) for postoperative pain control in adult patients undergoing elective open thoracotomy with one-lung ventilation. The primary outcome is the mean pain intensity at rest assessed by the Numeric Verbal Scale (NVS 0-10) during the first 48 hours after surgery. A total of 80 participants will be randomized 1:1 at Hospital de Clínicas de Porto Alegre, Brazil. The study aims to determine whether BPV provides non-inferior analgesia compared to BPD, with a potential advantage of less hemodynamic interference and better postoperative mobilization.
Detailed description
This is a randomized, assessor-blinded, non-inferiority clinical trial conducted at Hospital de Clínicas de Porto Alegre, Brazil, in adult patients undergoing elective open thoracotomy with one-lung ventilation. The objective is to compare the analgesic efficacy of continuous thoracic paravertebral block (BPV) versus continuous thoracic epidural block (BPD) for postoperative pain control during the first 48 hours after surgery.
Patients will be randomly allocated to two groups (40 per group). In the BPV group, the paravertebral catheter is inserted at the end of surgery under direct thoracoscopic vision (without ultrasound), using a bolus of ropivacaine 0.375% (15 mL fractionated) followed by continuous infusion of bupivacaine 0.125% at 0.10 mL/kg/h. In the BPD group, the epidural catheter is inserted at the beginning of surgery using the loss-of-resistance technique with the same bolus and infusion regimen. The target dermatomal level is T5-T7 (or T5-T9).
The primary outcome is the mean pain score at rest measured by the Numeric Verbal Scale (NVS 0-10) at 6, 12, 24, and 48 hours postoperatively. Secondary outcomes include pain on movement, total opioid consumption (converted to morphine equivalents), block-related complications (hypotension, urinary retention, technical failure, motor block), clinically significant pulmonary and cardiovascular complications, length of hospital stay, and patient satisfaction with analgesia.
Randomization is centralized using variable block sizes and sealed numbered envelopes. Outcome assessors are blinded to allocation. Both groups receive identical multimodal analgesia and a standardized rescue protocol. The sample size of 80 participants was calculated to demonstrate non-inferiority with a margin of 1 point on the NVS (expected SD = 1.5; 80% power; one-sided α = 0.025).
The study was approved by the Research Ethics Committee of HCPA (Opinion No. 8.544.882; CAAE 98467026.8.0000.5327) and will be conducted in accordance with the Declaration of Helsinki and current Brazilian regulations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a two-arm, parallel-group, randomized controlled non-inferiority trial. Participants are randomly assigned in a 1:1 ratio to either the continuous thoracic paravertebral block group (BPV) or the continuous thoracic epidural block group (BPD). Both groups receive catheter-based regional analgesia using the same initial bolus (ropivacaine 0.375%, 15 mL) and continuous infusion (bupivacaine 0.125% at 0.10 mL/kg/h). The parallel design allows direct head-to-head comparison of the two techniques for non-inferiority in postoperative pain control during the first 48 hours, with blinded outcome assessment.
| Arm | Type | Receives |
|---|---|---|
| Paravertebral Block Group | Experimental | Procedure: Continuous Thoracic Paravertebral BlockParticipants randomized to the continuous thoracic paravertebral block (BPV) group. At the end of surgery and before chest tube placement, a paravertebral catheter is inserted under direct thoracoscopic vision (without ultrasound) using a Tuohy needle. A bolus of ropivacaine 0.375% (15 mL, fractionated) is administered, followed by continuous infusion of bupivacaine 0.125% at 0.10 mL/kg/h. The target level is T5-T7 (or T5-T9). The catheter remains in place for at least 48 hours postoperatively. |
| Epidural Block Group | Active comparator | Procedure: Continuous Thoracic Epidural BlockParticipants randomized to the continuous thoracic epidural block (BPD) group. At the beginning of surgery, an epidural catheter is inserted at the thoracic level using the loss-of-resistance technique. A bolus of ropivacaine 0.375% (15 mL, fractionated) is administered, followed by continuous infusion of bupivacaine 0.125% at 0.10 mL/kg/h. The target level is T5-T7 (or T5-T9). The catheter remains in place for at least 48 hours postoperatively. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 18 years or older;
- Elective thoracic surgeries requiring open thoracotomy;
- American Society of Anesthesiologists (ASA) physical status I to III.
Key exclusion criteria (13 listed)
- Pregnancy or lactation;
- Urgent or emergency surgeries;
- Contraindications to epidural catheter insertion or neuraxial anesthesia;
- Infection at the proposed block site;
- Patient refusal to undergo the study blocks;
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 |
|---|---|---|
| Continuous Thoracic Paravertebral BlockParticipants randomized to the continuous thoracic paravertebral block (BPV) group. At the end of surgery and before chest tube placement, a paravertebral catheter is inserted under direct thoracoscopic vision (without ultrasound) using a Tuohy needle. A bolus of ropivacaine 0.375% (15 mL, fractionated) is administered, followed by continuous infusion of bupivacaine 0.125% at 0.10 mL/kg/h. The target level is T5-T7 (or T5-T9). The catheter remains in place for at least 48 hours postoperatively. | Procedure or surgery | Paravertebral Block Group |
| Continuous Thoracic Epidural BlockParticipants randomized to the continuous thoracic epidural block (BPD) group. At the beginning of surgery, an epidural catheter is inserted at the thoracic level using the loss-of-resistance technique. A bolus of ropivacaine 0.375% (15 mL, fractionated) is administered, followed by continuous infusion of bupivacaine 0.125% at 0.10 mL/kg/h. The target level is T5-T7 (or T5-T9). The catheter remains in place for at least 48 hours postoperatively. | Procedure or surgery | Epidural Block Group |
Primary outcome
Mean pain intensity at rest during the first 48 hours after surgery
Time frame: 6, 12, 24, and 48 hours after surgery
Mean of the pain scores at rest measured by the Numeric Verbal Scale (NVS 0-10) at 6, 12, 24, and 48 hours postoperatively. This composite measure is the primary endpoint for the non-inferiority comparison between continuous thoracic paravertebral block and continuous thoracic epidural block.
6 secondary outcomes
Pain on movement
Time frame: 6, 12, 24, and 48 hours after surgery
Total opioid consumption in the first 48 hours
Time frame: 0 to 48 hours after surgery
Block-related complications
Time frame: During the first 48 hours after surgery
Clinically significant pulmonary and cardiovascular complications
Time frame: Up to 72 hours after surgery
Length of hospital stay
Time frame: From surgery until hospital discharge (assessed up to 30 days)
Patient satisfaction with analgesia
Time frame: 48 hours 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 13 Aug 2026.
- Background: PubMed 28061899Perumal-Pillay VA, Suleman F. Selection of essential medicines for South Africa - an analysis of in-depth interviews with national essential medicines list committee members. BMC Health Serv Res. 2017 Jan 7;17(1):17. doi: 10.1186/s12913-016-1946-9.
- Background: PubMed 10512270Talmor D, Merkind V, Artru AA, Shapiro O, Geva D, Roytblat L, Shapira Y. Treatments to support blood pressure increases bleeding and/or decreases survival in a rat model of closed head trauma combined with uncontrolled hemorrhage. Anesth Analg. 1999 Oct;89(4):950-6. doi: 10.1097/00000539-199910000-00024.
- Background: PubMed 24623122Gupta T, Gupta SK, Sahni D. Anatomy of the tentorial segment of the trochlear nerve in reference to its preservation during surgery for skull base lesions. Surg Radiol Anat. 2014 Dec;36(10):967-71. doi: 10.1007/s00276-014-1278-6. Epub 2014 Mar 13.
- Background: PubMed 23235989Weitzel NS. Anesthesia and airway surgery. Semin Cardiothorac Vasc Anesth. 2012 Dec;16(4):181. doi: 10.1177/1089253212465019. No abstract available.
- Background: PubMed 18784542Bard RL, Gillespie BW, Patel H, Nicklas JM. Prognostic ability of resting periodic breathing and ventilatory variation in closely matched patients with heart failure. J Cardiopulm Rehabil Prev. 2008 Sep-Oct;28(5):318-22. doi: 10.1097/01.HCR.0000336143.02064.0e.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers. Only aggregated and de-identified results will be published. All data will be stored securely and confidentially in accordance with institutional policies and Brazilian data protection laws (LGPD).
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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.
Cristiano F Andrade, MD, PhD principal investigator
Federal University of Rio Grande do Sul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Thoracic Paravertebral Block and Continuous Thoracic Epidural Block in people with Postoperative Pain, run by Hospital de Clinicas de Porto Alegre 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 3 inclusion and 13 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 13 Aug 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 Cristiano F Andrade, MD, PhD (+55513359-6246, cfandrade@hcpa.edu.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean pain intensity at rest during the first 48 hours after surgery (time frame: 6, 12, 24, and 48 hours 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 NCT07763249, which also lists 5 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 13 Aug 2026.