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

NCT07763249 | Not Yet Recruiting DMC

• 2 other identifiers: 98467026.8.0000.53272026-0110
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Pain

Keywords

Postoperative Pain; Thoracotomy; Acute Pain; Thoracic Surgery; Regional Anesthesia

Outcome Measures

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.

  6, 12, 24, and 48 hours after surgery

Secondary Outcomes (6)

• Pain on movement

  6, 12, 24, and 48 hours after surgery

• Total opioid consumption in the first 48 hours

  0 to 48 hours after surgery

• Block-related complications

  During the first 48 hours after surgery

• Clinically significant pulmonary and cardiovascular complications

  Up to 72 hours after surgery

• Length of hospital stay

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

Study Arms (2)

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.

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.

Procedure: Continuous Thoracic Epidural Block

Interventions

Continuous Thoracic Paravertebral Block PROCEDURE

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.

Paravertebral Block Group

Continuous Thoracic Epidural Block PROCEDURE

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.

Epidural Block Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital de Clínicas de Porto Alegre (HCPA)

Porto Alegre, Rio Grande Do Sul (RS), 90410-000, Brazil

Location

Related Publications (5)

• 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.

  PMID: 28061899 BACKGROUND

• 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.

  PMID: 10512270 BACKGROUND

• 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.

  PMID: 24623122 BACKGROUND

• Weitzel NS. Anesthesia and airway surgery. Semin Cardiothorac Vasc Anesth. 2012 Dec;16(4):181. doi: 10.1177/1089253212465019. No abstract available.

  PMID: 23235989 BACKGROUND

• 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.

  PMID: 18784542 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Acute Pain

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Cristiano F Andrade, MD, PhD

  Federal University of Rio Grande do Sul

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cristiano F Andrade, MD, PhD

CONTACT

+55513359-6246; cfandrade@hcpa.edu.br

Andre P. Schmidt, MD, MSc, PhD

CONTACT

+5551996412212; apschmidt@hcpa.edu.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The study is single-blind (outcomes assessor blinded). Due to the nature of the interventions, patients and the clinicians performing or managing the blocks (thoracic surgeons and anesthesiologists) are not blinded. Outcome assessors who evaluate pain scores, opioid consumption, and complications remain blinded to participant allocation. Randomization is centralized with sealed numbered envelopes to ensure allocation concealment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 10, 2026
• First Posted: August 13, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: August 13, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)