ClinicalTrials.gg
Not yet recruitingNCT07763249Updated Aug 13, 2026

Comparison of Paravertebral Versus Epidural Block for Post-thoracotomy Pain Control

An interventional study of Continuous Thoracic Paravertebral Block and Continuous Thoracic Epidural Block in Postoperative Pain, sponsored by Hospital de Clinicas de Porto Alegre. Not yet recruiting at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-13.

Sponsored by Hospital de Clinicas de Porto Alegre · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 56 studies in Pain, Postoperative with a site in Brazil — 8 open to participants now, 8 under way, 1 of them phase 3. Pain, Postoperative · Brazil.

Planned enrollment
17th of 53
80 · median 70
Started
2026
with 3 others
No phase
21 of 56
6 open now
Registered
55th of 56
by date

Among the 56 studies in Pain, Postoperative with a site in Brazil, this one is the 17th largest by planned enrollment of the 53 interventional ones, is one of 4 that started in 2026, is one of 21 with no phase, and was the 55th registered.

By phase

56 studies; the count open now beside each. This study's row is marked.

No phasethis study21 · 6 open
Phase 420 · 0 open
Phase 35 · 0 open
Observational3 · 1 open
Phase 1/22 · 0 open
Phase 22 · 0 open
Phase 2/32 · 1 open
Phase 11 · 0 open

By the year they started

First in 1999; this study’s year is marked. 4 started in 2026.

Size and results

Median enrollment 70 across the 53 interventional studies, 800 across the 3 observational. Of the 36 that completed or were terminated, 3 (8%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 56 studies in Pain, Postoperative with a site in Brazil, or all of them as a file.
02

Study 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. 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.

03

Conditions studied

  • Postoperative Pain

Keywords

  • Postoperative Pain
  • Thoracotomy
  • Acute Pain
  • Thoracic Surgery
  • Regional Anesthesia
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients aged 18 years or older;
  • Elective thoracic surgeries requiring open thoracotomy;
  • (ASA) physical status I to III.

Exclusion criteria

Exclusion Criteria:

  • Pregnancy or lactation;
  • Urgent or emergency surgeries;
  • to epidural catheter insertion or neuraxial anesthesia;
  • Infection at the proposed block site;
  • Patient refusal to undergo the study blocks;
  • Video-assisted thoracic surgeries;
  • 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;
  • > 35 kg/m²;
  • Advanced liver or kidney failure ( C or estimated \< 50 mL/min/1.73 m²);
  • Severe cognitive impairment that prevents understanding of instructions or pain assessment.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Child-Pugh class

A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Paravertebral Block Group

    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.

    Procedure: Continuous Thoracic Paravertebral Block

  • Active comparator
    Epidural Block Group

    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.

    Procedure: Continuous Thoracic Epidural Block

Interventions

  • ProcedureContinuous Thoracic Paravertebral Block

    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.

  • ProcedureContinuous Thoracic Epidural Block

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6, 12, 24, and 48 hours after surgery

Secondary outcomes

  1. 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.

    Time frame: 6, 12, 24, and 48 hours after surgery

  2. 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.

    Time frame: 0 to 48 hours after surgery

  3. 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.

    Time frame: During the first 48 hours after surgery

  4. 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.

    Time frame: Up to 72 hours after surgery

  5. Length of hospital stay

    Total number of days from surgery until hospital discharge.

    Time frame: From surgery until hospital discharge (assessed up to 30 days)

  6. 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.

    Time frame: 48 hours after surgery

07

Study locations

1 site
08

References and documents

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 28061899 ↗
  • Talmor 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 10512270 ↗
  • Gupta 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 24623122 ↗
  • Weitzel NS. Anesthesia and airway surgery. Semin Cardiothorac Vasc Anesth. 2012 Dec;16(4):181. doi: 10.1177/1089253212465019. No abstract available. PubMed 23235989 ↗
  • Bard 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 ↗

Individual participant data

Plan to share: 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).

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Jan 2028, 16 months later.

Of 2,089 non-industry interventional studies with no phase under Pain, Postoperative, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 23. This study's planned 16 months is above that.

Counting every sponsor, half of 2,102 studies reached it within 11 months; a quarter within 6 and three quarters within 23.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 10, 2026
First posted
Aug 13, 2026
StartEst.
Sep 1, 2026
Primary completionEst.
Jan 31, 2028
CompletionEst.
Jul 31, 2028
Last update
Aug 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07763249
Responsible party
Sponsor
First posted
Aug 13, 2026
Start date
Sep 1, 2026 (estimated)
Primary completion
Jan 31, 2028 (estimated)
Completion
Jul 31, 2028 (estimated)
Last update
Aug 13, 2026

Study contacts

Cristiano F Andrade, MD, PhD
Contact
cfandrade@hcpa.edu.br
+55513359-6246
Andre P. Schmidt, MD, MSc, PhD
Contact
apschmidt@hcpa.edu.br
+5551996412212
Cristiano F Andrade, MD, PhD
principal investigator · Federal University of Rio Grande do Sul

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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