RecruitingPhase 4NCT06353529

Postop Pain Management in Pituitary Tumour Patients

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


Sponsor

Hamilton Health Sciences Corporation

Enrollment

108 participants

Start Date

Nov 25, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 100 Years

Inclusion Criteria2

  • adult patients (18 yrs or older)
  • undergoing endonasal pituitary adenoma resection

Exclusion Criteria6

  • 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)

Interventions

DRUGBupivacaine-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

DRUGPlacebo

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

DRUGSham Comparator

Participants receive no additional study injections


Locations(1)

Hamilton General Hospital

Hamilton, Ontario, Canada

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06353529


Related Trials