Sphenopalatine Ganglion Block for Postop Pain Management

Pain, Postoperative Clinical Trial

— SPGB  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06353529
• Other study ID #: 17065
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: May 2024
• Est. completion date: May 2025

Study information

• Verified date: April 2024
• Source: Hamilton Health Sciences Corporation
• Contact: Dr. Kesava Reddy, MD
• Phone: 905-521-2100
• Email: reddy[@]hhsc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. The aim is to improve patient outcomes and reduce the need for pain medication after surgery.

Description:

To further improve the quality of the early postoperative course, the investigators propose the use of the sphenopalatine ganglion (SPG) block (SPGB) for pain management in the context of an enhanced recovery after surgery (ERAS) protocol for minimally invasive (MIS) endoscopic transsphenoidal pituitary surgery. The SPG is the main sensory innervation to the nasal mucosa, and several studies have shown the analgesic efficacy of SPGB following sinus surgery and showed positive results for endoscopic sinus surgery. However, there is limited research on the use of SPGB in the context of pituitary surgery.

In this randomized placebo-controlled trial, the investigators aim to assess the benefit of SPGB with bupivacaine in addition to multimodal general anesthesia on pain management, after MIS pituitary surgery. The results of the trial will provide valuable insights into the potential benefits of SPGB and its optimal use for pituitary surgery.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 52
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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)

Related Conditions & MeSH terms

• Ganglion Cysts
• Pain, Postoperative
• Pituitary
• Pituitary Diseases

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Canada	Hamilton General Hospital	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation

Country where clinical trial is conducted

Canada, 

References & Publications (5)

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 — View Citation

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. — View Citation

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. Ep — View Citation

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: 10.1177/21526567188212 — View Citation

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 Ja — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Post-operative bleeding	amount of post-op bleeding (mL) in first 24 hours	through study completion, approximately 1 year
Secondary	Post-operative complications	record presence of post-op nausea/vomiting, headache, sore throat, difficulty swallowing in first 24 hours	through study completion, approximately 1 year
Secondary	Analgesic requirement	List and dose of analgesics administered to patient in first 24 hours or time of discharge, whichever comes first	through study completion, approximately 1 year
Secondary	Length of stay	Length of hospital stay in hours	through study completion, approximately 1 year