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Clinical Trials in Canada / NCT06353529
Recruiting Phase 4

Postop Pain Management in Pituitary Tumour Patients

NCT06353529 · tracked via the Priya Life Science Canada tracker
Phase
Phase 4
Started
2024-11-25
Last updated
2026-03-12

Condition(s) studied

PituitaryPain, Postoperative

Investigational drug(s) / intervention(s)

Bupivacaine-Epinephrine 0.5%-1:200,000 Injectable SolutionPlaceboSham Comparator

Bupivacaine-Epinephrine 0.5%-1:200,000 Injectable Solution: 2mL injection bilateral (4mL total) of 0.5% bupivacaine with 1:200,000 epinephrine solution, 20G needle, sterile, sphenopalatine ganglion; nerve block

Placebo: 2mL injection bilateral (4mL total) 0.9% saline solution, 20G needle, sterile, sphenopalatine ganglion; nerve block

Sham Comparator: Participants receive no additional study injections

Study summary

To assess the benefit of using an additional nerve block during minimally invasive pituitary surgery, to improve pain management after surgery. The medication (Bupivacaine) or a placebo (saline) will be injected during surgery and patients will be asked about their level of pain at multiple time points in the first 24 hours following surgery. Some patients will be randomized to a third, sham group that do not receive any additional injection. The aim is to improve patient outcomes and reduce the need for pain medication after surgery.

Eligibility

Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
Inclusion Criteria: * adult patients (18 yrs or older) * undergoing endonasal pituitary adenoma resection Exclusion Criteria: * Patients with pre-existing chronic pain conditions requiring antidepressants (serotonin reuptake inhibitors), benzodiazepines, gabapentin, or opioid drugs * contraindications to the performance of SPGB such as known allergy to used medications * chronic alcohol abuse * uncontrolled systemic arterial hypertension * severe kidney or liver diseases * cardiomyopathies or sustained cardiac arrhythmias (permanent paroxystic atrial fibrillation or other sustained supraventricular rhythmic anomalies)

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Hamilton General Hospital Hamilton Ontario Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06353529 on ClinicalTrials.gov ↗ ← All trials in Canada