Postop Pain Management in Pituitary Tumour Patients
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-100
SponsorHamilton Health Sciences Corporation
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
adult patients (18 yrs or older)
undergoing endonasal pituitary adenoma resection
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Bupivacaine-Epinephrine 0.5%-1:200,000 Injectable Solution
Drug2mL injection bilateral (4mL total) of 0.5% bupivacaine with 1:200,000 epinephrine solution, 20G needle, sterile, sphenopalatine ganglion; nerve block
Placebo
Drug2mL injection bilateral (4mL total) 0.9% saline solution, 20G needle, sterile, sphenopalatine ganglion; nerve block
Sham Comparator
DrugParticipants receive no additional study injections
Treatment groups
108 Participants
are divided into 3 treatment groupsGroup A: Bupivacaine injectionExperimental treatment 1 intervention
Group B: Placebo ControlPlacebo comparator 1 intervention
Group C: Sham - no injectionSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Post-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 yearSecondary outcomes
1
Post-operative bleeding
amount of post-op bleeding (mL) in first 24 hours
Time frame
through study completion, approximately 1 year2
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 year3
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 year4
Length of stay
Length of hospital stay in hours
Time frame
through study completion, approximately 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov