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Thoracic Epidural Anesthesia Versus Paravertebral Block for Awake Thoracotomy

Thoracic Epidural Anesthesia Versus Paravertebral Block for Awake Thoracotomy: A Randomized Non-inferiority Trial

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06974643
Enrollment
60
Registered
2025-05-16
Start date
2025-05-15
Completion date
2025-10-01
Last updated
2025-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thoracic Epidural Anesthesia, Paravertebral Block, Awake Thoracotomy

Brief summary

This study aims to compare paravertebral block and thoracic epidural in awake thoracotomy.

Detailed description

Pain can often persist after thoracotomy, and the incidence of chronic pain is high, with studies revealing that 30% to 50% of patients still experience pain up to five years after surgery. Thoracic epidural blockade (TEB) blocks nerves that supply the chest with local anesthetic bilaterally, at the spinal cord level. It acts by reducing the onward transmission of painful nerve signals, but may not abolish them altogether. Paravertebral blockade (PVB) involves injecting local anesthetic into the paravertebral space, which contains spinal nerves (and sometimes even extension of the dura), white and grey rami communicantes, the sympathetic chain, and intercostal vessels, on the side of surgery.

Interventions

Patients will preoperatively receive an awake thoracic epidural block.

OTHERParavertebral block

Patients will preoperatively receive a paravertebral block.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* Age from 18 to 60 years. * Both genders. * American Society of Anesthesiologists (ASA) physical status classification II or III. * Scheduled for thoracotomy.

Exclusion criteria

* Poor cardiac function (ejection fraction less than 50%). * Patients with bad pulmonary function testing (PFTs). Absolute contraindication to thoracic epidural anesthesia includes patient refusal, allergy to local anesthetics, coagulopathy, active neurologic disorders, skin infection at the insertion site, uncooperative patients, uncontrolled cough, and unfavorable anatomy for thoracic epidural. * Thoracic spine disorders require chest wall resection or emergency thoracic surgery. * Had a previous thoracotomy (scarring due to prior surgery can limit the effectiveness of paravertebral block, and these patients may have existing chronic pain).

Design outcomes

Primary

MeasureTime frameDescription
Intraoperative fentanyl consumptionIntraoperativelyAdditional bolus doses of fentanyl 0.5µg/kg will be given if the mean arterial blood pressure or heart rate rises above 20% of baseline levels.

Secondary

MeasureTime frameDescription
Mean arterial pressureTill the end of surgery (Up to 2 hours)Mean arterial pressure will be recorded at baseline, and every 15min till the end of surgery
Heart rateTill the end of surgery (Up to 2 hours)Heart rate will be recorded at baseline, and every 15min till the end of surgery
Total morphine consumption48 hours postoperativelyIf numeric rating scale (NRS)\>3 at rest will be observed, rescue analgesia via IV morphine 3 mg boluses will be administered.
Time to the 1st rescue analgesia48 hours postoperativelyTime to first request of rescue analgesia will be assessed from the end of surgery till first dose of morphine administrated.
Degree of patient satisfaction48 hours postoperativelyDegree of patient satisfaction will be assessed on a 5-point Likert scale patient satisfaction (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied; 5, extremely satisfied)
Incidence of adverse events48 hours postoperativelyIncidence of adverse events such as nausea, vomiting, respiratory depression, hypotension and bradycardia
Degree of pain48 hours postoperativelyThe patients will be instructed how to report pain by the numeric rating scale (NRS) \[on a scale from (0 to 10), zero means no pain and ten means the worst pain\]. NRS will be measured at post-anesthesia care unit (PACU), 1, 2, 4, 8, 12, 18, 24, 36, 48 hours postoperatively at rest and movement

Countries

Egypt

Contacts

Primary ContactMohamed E Abdel Fattah, MD
mohamed-elsaid@cu.edu.eg00201284475792

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026