Recruiting

Observational Study

Sponsor:

Hamilton Health Sciences Corporation

Code:

NCT06353529

Conditions

Pituitary

Pain, Postoperative

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Bupivacaine-Epinephrine 0.5%-1:200,000 Injectable Solution

Placebo

Sham Comparator

Study Details

Brief 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.

Conditions

Pituitary

Pain, Postoperative

Study ID

NCT06353529

Start date

Nov 25, 2024

Status verified date

Sep, 2025

Completion date

Jul, 2026

Anticipated

Primary completion date

Apr, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

108 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

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

Primary outcome measure

  • Post-operative pain score [ Time Frame: through study completion, approximately 1 year ]

Central Contacts and Locations

Central contacts

Dr. Kesava Reddy, MD

905-521-2100reddy@hhsc.ca

Ms. Jessy Moore, MSc

289-686-8827moorej@hhsc.ca

Locations

Hamilton General Hospital

Recruiting

Hamilton, Ontario, Canada, L8L 2X2

Contacts

Dr. Kesava Reddy, MD

905-521-2100reddy@hhsc.ca

Ms. Jessy Moore, MSc

289-686-8827moorej@hhsc.ca

More Information

Sponsor

Hamilton Health Sciences Corporation

Last update posted

Mar 12, 2026

Last verified

Sep, 2025

Keywords

  • Nerve block
  • Bupivacaine
  • Sphenopalatine Ganglion

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hamilton Health Sciences Corporation on 2026-03-12.