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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative bleeding | amount of post-op bleeding (mL) in first 24 hours | through study completion, approximately 1 year |
| Post-operative complications | record presence of post-op nausea/vomiting, headache, sore throat, difficulty swallowing in first 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kesava Reddy, MD | Contact | 905-521-2100 | reddy@hhsc.ca | |
| Ms. Jessy Moore, MSc | Contact | 289-686-8827 | moorej@hhsc.ca |
| Name | Affiliation | Role |
|---|---|---|
| Dr. Kesava Reddy, MD | Hamilton Health Sciences Corporatin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hamilton General Hospital | Recruiting | Hamilton | Ontario | L8L 2X2 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34013619 | Result | 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. | |
| 30719401 | Result |
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Patient data will be de-identified and the data will be analyzed as a whole before becoming available to other researchers.
De-identified IPD may be shared with other researchers if necessary based on occurrence of adverse events occurrence, circumstantial findings, etc.
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| ID | Term |
|---|---|
| D010900 | Pituitary Diseases |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Placebo | Drug | 2mL injection bilateral (4mL total) 0.9% saline solution, 20G needle, sterile, sphenopalatine ganglion; nerve block |
|
| Sham Comparator | Drug | Participants receive no additional study injections |
|
| through study completion, approximately 1 year |
| 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 |
| Length of stay | Length of hospital stay in hours | through study completion, approximately 1 year |
| 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. |
| 30296912 | 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. |
| 21739090 | 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. |
| 33388988 | 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. |
| D004700 | Endocrine System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |