A randomized placebo-controlled trial assessing sphenopalatine ganglion block in endoscopic sinus surgery.
Martin Morisse, Bénédicte Rysman, Claire Szymanski...
https://pubmed.ncbi.nlm.nih.gov/34013619Actively Recruiting
Phase 4
Age: 18Years - 100Years
All Genders
ID06353529
Effect of Sphenopalatine Ganglion Block With Bupivacaine on Postoperative Pain in Patients Undergoing Endoscopic Pituitary Adenoma Resection
Led by Hamilton Health Sciences Corporation · Updated on 2026-03-12
108
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of an additional nerve block called the sphenopalatine ganglion block (SPGB) during minimally invasive endoscopic pituitary surgery to improve pain management after surgery. This study aims to determine whether adding SPGB with bupivacaine to standard general anesthesia can reduce postoperative pain and the need for pain medication. The trial is randomized and placebo-controlled, focusing on patients undergoing pituitary adenoma resection. Participants are divided into three groups: one group receives bilateral injections of 0.5% bupivacaine with epinephrine into the sphenopalatine ganglion, another group receives a placebo injection of saline solution in the same manner, and a third group undergoes the standard surgery without any additional injections. The injections are given during surgery using a 20G needle, with 2 mL of fluid injected on each side. During the study, patients will be asked to report their pain levels multiple times within the first 24 hours after surgery. Researchers will monitor post-operative pain scores, bleeding, complications, pain medication use, and length of hospital stay over about one year. The study includes regular assessments and safety monitoring to help understand the potential benefits and risks of using SPGB for pain relief after pituitary surgery.
CONDITIONS
Brief Title
Postop Pain Management in Pituitary Tumour Patients
Who Can Participate
Age: 18Years - 100Years
All Genders
Eligibility Criteria
You may qualify if you...
- Adult patients aged 18 years or older
- Undergoing endonasal pituitary adenoma resection
You will not qualify if you...
- Patients with chronic pain conditions requiring antidepressants, benzodiazepines, gabapentin, or opioid drugs
- Known allergy to medications used for sphenopalatine ganglion block
- Chronic alcohol abuse
- Uncontrolled systemic arterial hypertension
- Severe kidney or liver diseases
- Cardiomyopathies or sustained cardiac arrhythmias (such as permanent or paroxysmal atrial fibrillation or other sustained supraventricular rhythm anomalies)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Surgery day and immediate postoperative period
Participants undergo minimally invasive endoscopic transsphenoidal pituitary surgery and receive either a sphenopalatine ganglion block with bupivacaine, a placebo injection, or no additional injection as part of their pain management.
1 visit (in-person)
Post-operative Follow-up
Duration - Approximately 1 year
Participants are monitored for postoperative pain, bleeding, complications, analgesic requirements, and length of hospital stay for up to approximately 1 year after surgery.
Regular follow-up visits during the year after surgery
Trial Site Locations
Total: 1 location
1
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2
Actively Recruiting
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Research Team
D
Dr. Kesava Reddy, MD
M
Ms. Jessy Moore, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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Published Research Related To This Trial
Effect of Sphenopalatine Ganglion Block With Bupivacaine on Postoperative Pain in Patients Undergoing Endoscopic Sinus Surgery.
Ahmad Rezaeian, Seyed Mostafa Hashemi, Zeinab Sadat Dokhanchi
https://pubmed.ncbi.nlm.nih.gov/30719401The Effect of Sphenopalatine Block on the Postoperative Pain of Endoscopic Sinus Surgery: A Meta-analysis.
Do Hyun Kim, Haram Kang, Se Hwan Hwang
https://pubmed.ncbi.nlm.nih.gov/30296912Role of sphenopalatine ganglion block for postoperative analgesia after functional endoscopic sinus surgery.
Elvin Kesimci, Levent Öztürk, Sami Bercin...
https://pubmed.ncbi.nlm.nih.gov/21739090The efficacy of sphenopalatine ganglion block for pain management after endoscopic sinus surgery: a meta-analysis of randomized controlled studies.
Ping Wang
https://pubmed.ncbi.nlm.nih.gov/33388988