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

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.

Study Overview

• Status: Completed
• Conditions: Post-operative Surgical Pain
• Intervention / Treatment: Procedure: Nerve Block with ropivicaine 0.5% Injectable Solution; Procedure: Nerve Block with Placebo sham control of 0.9% Normal Saline

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.

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • UCSF Moffitt Long Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Nerve Block Procedure; Supra-orbital and Infra-orbital peripheral nerve blocks with 0.5% ropivicaine	Procedure: Nerve Block with ropivicaine 0.5% Injectable Solution; Peripheral nerve blocks using 0.5% ropivicaine
SHAM_COMPARATOR: Placebo sham control; sham control 0.9% Normal Saline	Procedure: Nerve Block with Placebo sham control of 0.9% Normal Saline; Peripheral Nerve Block with placebo 0.9% normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6 hour post-operative Morphine Requirements in milligrams (mg)	Systemic Intravenous (IV) morphine opioid consumption in mg in 2 groups during first 6 hours post-operatively (regional + general versus only general anesthesia)	6 hours post-op

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain exposure postoperative for 6 hours	Pain score out of max 10 (Scale 0-10). "O" (no Pain) and "10" (worst possible pain)	6 hours
Nausea and/or vomiting for 6 hours postoperatively	Nausea score out of max 10 (Scale 0-10)."O" (no nausea) and "10" (worst nausea possible). Presence of vomiting is minimum score of 5/10.	6 hours
Time to discharge from Post anesthesia care unit (PACU) in minutes	Time patient spends in PACU from entry time until discharge to the floor in minutes	post-operative period measured in minutes up to 120 minutes
Time to discharge from hospital in minutes	Time measured in minutes from surgery start to discharge from the hospital	post-operative time up to 36 hours

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Investigators: Principal Investigator: Una Srejic, MD, University of California, San Diego

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 15, 2017
• Primary Completion (ACTUAL): December 25, 2018
• Study Completion (ACTUAL): December 25, 2018

Study Registration Dates

• First Submitted: December 9, 2020
• First Submitted That Met QC Criteria: December 15, 2020
• First Posted (ACTUAL): December 17, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 17, 2020
• Last Update Submitted That Met QC Criteria: December 15, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: trigeminal nerve block; trans-sphenoidal endoscopic pituitary surgery; supra-orbital nerve block; infra-orbital nerve block
• Other Study ID Numbers: 15-15700

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No