Effect of Sphenopalatine Ganglion Block with Bupivacaine on Postoperative Pain in Patients Undergoing Endoscopic Pituitary Adenoma Resection
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:
• adult patients (18 yrs or older)
• undergoing endonasal pituitary adenoma resection
Locations
Other Locations
Canada
Hamilton General Hospital
RECRUITING
Hamilton
Contact Information
Primary
Dr. Kesava Reddy, MD
reddy@hhsc.ca
905-521-2100
Backup
Ms. Jessy Moore, MSc
moorej@hhsc.ca
289-686-8827
Time Frame
Start Date: 2024-11-25
Estimated Completion Date: 2026-01
Participants
Target number of participants: 108
Treatments
Experimental: Bupivacaine injection
This group will receive bilateral injection of 0.5% bupivacaine with 1:200,000 epinephrine using a 20G needle and comprising 2mL of fluid on each side (4mL total) into the sphenopalatine ganglion.
Placebo_comparator: Placebo Control
This group will receive bilateral injection of 0.9% saline solution using a 20G needle and comprising 2mL of fluid on each side (4mL total) into the sphenopalatine ganglion.
Sham_comparator: Sham - no injection
Participants randomized to this arm will not receive any additional study injections and will undergo the current standard procedure for patients undergoing endoscopic endonasal surgery.
Related Therapeutic Areas
Sponsors
Leads: Hamilton Health Sciences Corporation