METHODS
PONV, postoperative pain, tumors, pain
SECONDARY, TUMORS
Following Institutional Review Board approval at the University of California, San Francisco, USA (UCSF), study enrollment was offered to adult patients (male and female) (aged 18-65) having an ASA (American Society of Anesthesiologists) physical status I or II scheduled for same day admit endoscopic endo-nasal trans-sphenoidal hypophysectomy to be performed by a single surgeon (SK).This is a prospective, randomized, double-blinded sham-controlled (preservative-free normal saline) regional anesthetic (supra-orbital and infra-orbital nerve (SION)) study to compare the systemic postoperative pain medication requirements in patients having trans-sphenoidal endoscopic, endo-nasal pituitary surgery under general anesthesia. The study protocol was performed in accordance with the relevant guidelines and is included in detail below. The primary endpoint was systemic morphine sulfate PCA (patient-controlled analgesia) opioid consumption by the 2 groups during the first 6 hours postoperatively (regional + general anesthesia vs. general anesthesia alone). The secondary endpoints included: (1) pain exposure experienced by the patients postoperatively, (2) incidence of PONV, (3) time to eligibility for PACU discharge, and (4) length of hospital stay/discharge. To our knowledge, this is the first published clinical trial examining the use of SION block to control postoperative pain after endonasal pituitary surgery. The results from the two groups were compared using an unpaired Student t-test. Additional inclusion criteria were: (1) elective pituitary surgery for tumors less than or equal to 2 cm diameter within the sella turcica and without cavernous sinus invasion, (2) both male or female patients, (3) English-speaking patients providing informed consent, (4) not on chronic pre-op pain medications (non-narcotics) in the last week prior to surgery as per the patient report, (5) no opioid pain medications pre-op in the last month before surgery as per the patient report, (6) no abuse of recreational drugs (cocaine, methampheta mines, marijuana, opioids, heroin, After written informed consent, the subjects were randomly assigned to 1 of 2 groups using randomization envelopes in 3 blocks of 20. A “triple mask design” was used: the subjects, healthcare providers (including the anesthesiologist in the operating room and anesthesiologist administering the SION blocks), randomization consent nurse, and data collection nurse, as well as the statistician, were all blinded to the treatment groups assigned (Fig. 