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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
108
2mL injection bilateral (4mL total) of 0.5% bupivacaine with 1:200,000 epinephrine solution, 20G needle, sterile, sphenopalatine ganglion; nerve block
2mL injection bilateral (4mL total) 0.9% saline solution, 20G needle, sterile, sphenopalatine ganglion; nerve block
Participants receive no additional study injections
Hamilton General Hospital
Hamilton, Ontario, Canada
RECRUITINGPost-operative pain score
Pain score, measured by visual analog scale (scale of 0-10) at 6, 12 and 24 hours post-op
Time frame: through study completion, approximately 1 year
Post-operative bleeding
amount of post-op bleeding (mL) in first 24 hours
Time frame: 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
Time frame: 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
Time frame: through study completion, approximately 1 year
Length of stay
Length of hospital stay in hours
Time frame: through study completion, approximately 1 year
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