Sphenopalatine Ganglion Block for Postop Pain Management

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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)

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06353529
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 4
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Hamilton Health Sciences Corporation
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Dr. Kesava Reddy, MD
Principal Investigator Affiliation	Hamilton Health Sciences Corporatin
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries	Canada
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Pituitary, Pain, Postoperative

Additional Details

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.

Arms & Interventions

Arms

Experimental: Bupivacaine injection

This group will receive bilateral injection of 0.5% bupivacaine with 1:200,000 epinephrine using a 20G needle and comprising 2mL of fluid on each side (4mL total) into the sphenopalatine ganglion.

Placebo Comparator: Placebo Control

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.

Interventions

Drug: - Bupivacaine-Epinephrine 0.5%-1:200,000 Injectable Solution

2mL injection bilateral (4mL total) of 0.5% bupivacaine with 1:200,000 epinephrine solution, 20G needle, sterile, sphenopalatine ganglion; nerve block

Drug: - Placebo

2mL injection bilateral (4mL total) 0.9% saline solution, 20G needle, sterile, sphenopalatine ganglion; nerve block

Contact a Trial Team

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International Sites

Hamilton General Hospital, Hamilton, Ontario, Canada

Status

Address

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2

Site Contact

Dr. Kesava Reddy, MD

[email protected]

905-521-2100

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