Postop Pain Management in Pituitary Tumour Patients

NCT06353529 | Recruiting Phase 4

• 1 other identifier: 17065
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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

Keywords

Nerve block; Bupivacaine; Sphenopalatine Ganglion

Outcome Measures

Primary Outcomes (1)

• Post-operative pain score

  Pain score, measured by visual analog scale (scale of 0-10) at 6, 12 and 24 hours post-op

  through study completion, approximately 1 year

Secondary Outcomes (4)

• Post-operative bleeding

  through study completion, approximately 1 year

• Post-operative complications

  through study completion, approximately 1 year

• Analgesic requirement

  through study completion, approximately 1 year

• Length of stay

  through study completion, approximately 1 year

Study Arms (3)

Bupivacaine injection

EXPERIMENTAL

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.

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

Placebo Control

PLACEBO COMPARATOR

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.

Drug: Placebo

Sham - no injection

SHAM COMPARATOR

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.

Drug: Sham Comparator

Interventions

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

2mL injection bilateral (4mL total) of 0.5% bupivacaine with 1:200,000 epinephrine solution, 20G needle, sterile, sphenopalatine ganglion; nerve block

Bupivacaine injection

Placebo DRUG

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

Placebo Control

Sham Comparator DRUG

Participants receive no additional study injections

Sham - no injection

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead

Study Sites (1)

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

RECRUITING

Related Publications (5)

• Morisse M, Rysman B, Szymanski C, Fackeure R, Mouawad F, Mortuaire G. A randomized placebo-controlled trial assessing sphenopalatine ganglion block in endoscopic sinus surgery. Int Forum Allergy Rhinol. 2021 Sep;11(9):1384-1386. doi: 10.1002/alr.22804. Epub 2021 May 19. No abstract available.

  PMID: 34013619 RESULT

• Rezaeian A, Hashemi SM, Dokhanchi ZS. Effect of Sphenopalatine Ganglion Block With Bupivacaine on Postoperative Pain in Patients Undergoing Endoscopic Sinus Surgery. Allergy Rhinol (Providence). 2019 Jan 23;10:2152656718821282. doi: 10.1177/2152656718821282. eCollection 2019 Jan-Dec.

  PMID: 30719401 RESULT

• Kim DH, Kang H, Hwang SH. The Effect of Sphenopalatine Block on the Postoperative Pain of Endoscopic Sinus Surgery: A Meta-analysis. Otolaryngol Head Neck Surg. 2019 Feb;160(2):223-231. doi: 10.1177/0194599818805673. Epub 2018 Oct 9.

  PMID: 30296912 RESULT

• Kesimci E, Ozturk L, Bercin S, Kiris M, Eldem A, Kanbak O. Role of sphenopalatine ganglion block for postoperative analgesia after functional endoscopic sinus surgery. Eur Arch Otorhinolaryngol. 2012 Jan;269(1):165-9. doi: 10.1007/s00405-011-1702-z. Epub 2011 Jul 8.

  PMID: 21739090 RESULT

• Wang P. The efficacy of sphenopalatine ganglion block for pain management after endoscopic sinus surgery: a meta-analysis of randomized controlled studies. Eur Arch Otorhinolaryngol. 2021 Aug;278(8):2681-2687. doi: 10.1007/s00405-020-06484-9. Epub 2021 Jan 3.

  PMID: 33388988 RESULT

MeSH Terms

Conditions

Pituitary Diseases; Pain, Postoperative

Condition Hierarchy (Ancestors)

Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Dr. Kesava Reddy, MD

  Hamilton Health Sciences Corporatin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Kesava Reddy, MD

CONTACT

905-521-2100; reddy@hhsc.ca

Ms. Jessy Moore, MSc

CONTACT

289-686-8827; moorej@hhsc.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2024
• First Posted: April 9, 2024
• Study Start: November 25, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: March 12, 2026

Record last verified: 2025-09

Locations

CA (1)