NCT07907692|Not Yet Recruiting
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Sponsor study identifier
interventional
40
1 country
1
Study Start
September 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
May 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
May 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
The high thoracic paravertebral block is a regional anesthesia technique commonly used for oncologic breast surgery. Local anesthetic is injected into the paravertebral space to provide anesthesia and pain relief. Case reports suggest that cephalad spread of local anesthetic may occasionally affect the phrenic nerve and lead to temporary hemidiaphragmatic dysfunction, but the incidence of this complication is unknown. The goal of this prospective interventional study is to evaluate the impact of high thoracic paravertebral block on diaphragmatic function in patients undergoing unilateral oncologic breast surgery. Diaphragmatic function will be assessed using ultrasound before and after the block. The study will also evaluate postoperative pain, opioid consumption, respiratory symptoms, and other postoperative outcomes.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 26, 2026
Actual (reported)October 30, 2026
Actual (reported)May 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
May 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Incidence of ipsilateral hemidiaphragmatic dysfunction determined by diaphragm ultrasonography
The incidence of ipsilateral hemidiaphragmatic paralysis following high thoracic paravertebral block, assessed by diaphragm ultrasonography using the diaphragmatic thickening fraction (DTF).
Postoperative assessment in the PACU, approximately 1-3 hours after block placement.
Change in ipsilateral diaphragmatic excursion
Baseline (before block) and postoperative assessment in the PACU, approximately 1-3 hours after block placement.
Postoperative dyspnea
From PACU admission to PACU discharge (approximately 1-3 hours).
Participants undergoing unilateral oncologic breast surgery will receive an ultrasound-guided high thoracic paravertebral block using a standardized two-injection technique. After baseline diaphragmatic ultrasound assessment, a regional anesthesiologist will perform the block at the T1-T2 level and at a second thoracic level selected according to the surgical site using a total of 30 mL of local anesthetic (15 mL per injection). The block will be performed with the ultrasound transducer in the sagittal position about 2.5 to 3 centimeters (cm) lateral to the spinous process using a caudal to cranial in-plane needle approach. The thoracic vertebral levels will be identified by finding the first rib under ultrasound guidance and counting down levels appropriately. The needle (80 mm 22-gauge echogenic SonoPlex needle from Pajunk) will be introduced in-plane in a caudal to cranial. Diaphragmatic ultrasound measurements will be repeated in the post-anesthesia care unit following surgery.
already described in arm description
Maisonneuve-Rosemont Hospital
Montreal, Quebec, H1T 2M4, Canada
Ariane Clairoux, MD
Maisonneuve-Rosemont Hospital / CIUSSS de l'Est-de-l'Île-de-Montréal
First Submitted
October 26, 2026
First Posted
October 30, 2026
Study Start
September 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Oxygen desaturation
From PACU admission to PACU discharge (approximately 1-3 hours).
Supplemental oxygen requirement
From PACU admission to PACU discharge (approximately 1-3 hours).
Postoperative pain intensity
From PACU admission to PACU discharge (approximately 1-3 hours).
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Primary Completion
May 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
May 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 30, 2026
Record last verified: 2026-10
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Source: ClinicalTrials.gov.
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