Postop Pain Management in Pituitary Tumour Patients
- Conditions
- PituitaryPain, Postoperative
- Interventions
- Drug: PlaceboDrug: Sham Comparator
- Registration Number
- NCT06353529
- Lead Sponsor
- Hamilton Health Sciences Corporation
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 108
- adult patients (18 yrs or older)
- undergoing endonasal pituitary adenoma resection
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Control Placebo 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Post-operative bleeding through study completion, approximately 1 year amount of post-op bleeding (mL) 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
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
Trial Locations
- Locations (1)
Hamilton General Hospital
🇨🇦Hamilton, Ontario, Canada