Pain, Postoperative, Pituitary
Conditions
Keywords
Nerve block, Bupivacaine, Sphenopalatine Ganglion
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.
Detailed 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.
Interventions
2mL injection bilateral (4mL total) of 0.5% bupivacaine with 1:200,000 epinephrine solution, 20G needle, sterile, sphenopalatine ganglion; nerve block
DRUGPlacebo
2mL injection bilateral (4mL total) 0.9% saline solution, 20G needle, sterile, sphenopalatine ganglion; nerve block
DRUGSham Comparator
Participants receive no additional study injections
Sponsors
Hamilton Health Sciences Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative pain score | through study completion, approximately 1 year | Pain score, measured by visual analog scale (scale of 0-10) at 6, 12 and 24 hours post-op |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative bleeding | through study completion, approximately 1 year | amount of post-op bleeding (mL) in first 24 hours |
| Post-operative complications | through study completion, approximately 1 year | record presence of post-op nausea/vomiting, headache, sore throat, difficulty swallowing in first 24 hours |
| Analgesic requirement | through study completion, approximately 1 year | List and dose of analgesics administered to patient in first 24 hours or time of discharge, whichever comes first |
| Length of stay | through study completion, approximately 1 year | Length of hospital stay in hours |
Countries
Canada
Contacts
CONTACTDr. Kesava Reddy, MD
CONTACTMs. Jessy Moore, MSc
PRINCIPAL_INVESTIGATORDr. Kesava Reddy, MD
Hamilton Health Sciences Corporatin
Outcome results
None listed