RECRUITINGPhase 4INTERVENTIONAL

Postop Pain Management in Pituitary Tumour Patients

Effect of Sphenopalatine Ganglion Block With Bupivacaine on Postoperative Pain in Patients Undergoing Endoscopic Pituitary Adenoma Resection

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - adult patients (18 yrs or older) - undergoing endonasal pituitary adenoma resection Who Should NOT Join This Trial: - 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) Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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)

Treatments Being Tested

DRUG

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

DRUG

Placebo

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

DRUG

Sham Comparator

Participants receive no additional study injections

Locations (1)

Hamilton General Hospital

Hamilton, Ontario, Canada