Regional Anesthesia (Supra-Orbital and Infra-Orbital Nerve Block) (SION) for Pain Management in Trans-sphenoidal Hypophysectomy

Completed · Not applicable · Has a placebo group

Conditions studied: Post-operative Surgical Pain

In brief

This is a prospective, randomized, blinded, sham controlled regional anesthetic (supra-orbital and infra-orbital nerve block) pain study to compare the systemic postoperative pain medication requirements in patients having Trans-sphenoidal Pituitary surgery. The patients will receive general anesthesia +/- regional anesthesia for trans-sphenoidal pituitary surgery and systemic pain medication during the intra-operative and postoperative (6hrs) period. The amount of systemic pain medication requirements will be compared between those patients receiving regional and general anesthesia versus general anesthesia alone.

Key facts

Study ID

NCT04670614

Run by

University of California, San Francisco

People needed

49

Starts

2017-01-15

Expected to finish

2018-12-25

Last updated by the study team

2020-12-17

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Adult age between 18 and 65
• American Society of Anesthesiology (ASA) 1-2
• Elective pituitary tumor surgery, tumor less than or equal to 2 cm diameter within the sella and no cavernous
• sinus invasion
• Single surgeon, Dr. Kunwar
• Male and female patients
• English speaking
• Informed consent
• Not on chronic pre-opertaive pain medications (non-narcotics) in the last 1 week prior to surgery
• No opioid pain medications pre-op in the last 1 month before surgery
• No abuse of recreational drugs (cocaine, methamphetamines, THC (tetrahydrocannabinol), opioids/heroin)
• No herbal medications for pain in the 1-month prior to surgery

You may not qualify if…

• Age less than 18 years
• Non-English speaking
• Allergy to: Ropivicaine
• Chronic pain condition, including idiopathic migraine as defined by the ICHD (International Classification of Headache Disorders) II criteria, requiring the use of pain medications
• Inability to comprehend or adhere to study protocol

Where it is running

• UCSF Moffitt Long Hospital — San Francisco, California, United States

Full record on ClinicalTrials.gov

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