Regional Anesthesia (Supra-Orbital and Infra-Orbital Nerve Block) (SION) for Pain Management in Trans-sphenoidal Hypophysectomy
Condition: Post-operative Surgical Pain
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      Combined regional and general anesthesia for surgery is known to provide superior pain
      control in the peri-operative period (intra and post-operative). Of particular interest in
      neurosurgery are more rapid patient awakening and earlier ability to perform adequate
      post-operative neurological exam. In addition to this, regional anesthesia can decrease the
      total amount of systemic pain medications necessary and thus decrease their associated side
      effects. Consequently, less systemic pain medications can benefit the patient in many ways.

      By modifying the postop pain regime to include intraoperative regional anesthesia, there
      could be increased patient satisfaction, and significant economic gains to the hospital
      through a more streamlined, shorter, more pleasant hospital course for the patient. Patients
      who have this trans-sphenoidal pituitary surgery are usually same day admission patients who,
      following their surgery, are admitted for up to 24 hours postoperatively. Usually prolonged
      admissions result from headache and nausea +/- vomiting. Etiology of the headache is likely
      multifactorial. One theory is that stimulation of the peripheral trigeminal (Cranial Nerve
      Number V) fibers in the V1 and V2 distribution of the face by the surgical endoscope and
      surgical trauma may lead to release of inflammatory mediators and post-operative migraine. It
      has been shown that repetitive injection of local anesthetics in the distribution of
      supra-orbital nerve V1 and infra-orbital nerve V2 can decrease the incidence of chronic
      idiopathic migraine headaches not related to surgery. By administering regional anesthesia to
      the patient intra-operatively during their general anesthetic for the surgery, pain scores
      may be reduced, PONV (postoperative nausea and vomiting) decreased, and hospital stay
      shortened.This study will be examining the use of regional anesthesia (infra-orbital and
      supra-orbital nerve blocks) combined with general anesthesia versus general anesthesia to
      observe the systemic opioid consumptions of adult transsphenoidal pituitary surgery patients.
      Secondary endpoints of the study will be: (1) presence of PONV, (2) time in PACU (post
      anesthesia care unit) and finally, (3) duration of hospital stay until discharge.
    

Intervention name(s): Nerve Block with ropivicaine 0.5% Injectable Solution; Nerve Block with Placebo sham control of 0.9% Normal Saline
Intervention type(s): Procedure; Procedure
Intervention description(s): Peripheral nerve blocks using 0.5% ropivicaine; Peripheral Nerve Block with placebo 0.9% normal saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: trigeminal nerve block; trans-sphenoidal endoscopic pituitary surgery; supra-orbital nerve block; infra-orbital nerve block