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Trial Title:
Sphenopalatine Ganglion Block for Postop Pain Management
NCT ID:
NCT06353529
Condition:
Pituitary
Pain, Postoperative
Conditions: Official terms:
Ganglion Cysts
Pituitary Diseases
Pain, Postoperative
Epinephrine
Bupivacaine
Conditions: Keywords:
Nerve block
Bupivacaine
Sphenopalatine Ganglion
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
Bupivacaine-Epinephrine 0.5%-1:200,000 Injectable Solution
Description:
2mL injection bilateral (4mL total) of 0.5% bupivacaine with 1:200,000 epinephrine
solution, 20G needle, sterile, sphenopalatine ganglion; nerve block
Arm group label:
Bupivacaine injection
Intervention type:
Drug
Intervention name:
Placebo
Description:
2mL injection bilateral (4mL total) 0.9% saline solution, 20G needle, sterile,
sphenopalatine ganglion; nerve block
Arm group label:
Placebo Control
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. 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.
Criteria for eligibility:
Criteria:
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)
Gender:
All
Minimum age:
18 Years
Maximum age:
100 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Hamilton General Hospital
Address:
City:
Hamilton
Zip:
L8L 2X2
Country:
Canada
Contact:
Last name:
Dr. Kesava Reddy, MD
Phone:
905-521-2100
Email:
reddy@hhsc.ca
Contact backup:
Last name:
Ms. Jessy Moore, MSc
Phone:
289-686-8827
Email:
moorej@hhsc.ca
Start date:
May 2024
Completion date:
May 2025
Lead sponsor:
Agency:
Hamilton Health Sciences Corporation
Agency class:
Other
Source:
Hamilton Health Sciences Corporation
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06353529
