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

NCT ID: NCT04670614

Last Updated: 2020-12-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-15
• Study Completion Date: 2018-12-25

Brief 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.

Conditions

Post-operative Surgical Pain

Keywords

trigeminal nerve block; trans-sphenoidal endoscopic pituitary surgery; supra-orbital nerve block; infra-orbital nerve block

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Nerve Block Procedure

Supra-orbital and Infra-orbital peripheral nerve blocks with 0.5% ropivicaine

Group Type: OTHER

Nerve Block with ropivicaine 0.5% Injectable Solution

Intervention Type: PROCEDURE

Peripheral nerve blocks using 0.5% ropivicaine

Placebo sham control

sham control 0.9% Normal Saline

Group Type: SHAM_COMPARATOR

Nerve Block with Placebo sham control of 0.9% Normal Saline

Intervention Type: PROCEDURE

Peripheral Nerve Block with placebo 0.9% normal saline

Interventions

Nerve Block with ropivicaine 0.5% Injectable Solution

Peripheral nerve blocks using 0.5% ropivicaine

Intervention Type: PROCEDURE

Nerve Block with Placebo sham control of 0.9% Normal Saline

Peripheral Nerve Block with placebo 0.9% normal saline

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Una Srejic, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

UCSF Moffitt Long Hospital

San Francisco, California, United States

Countries

United States

References

Srejic U, Litonius E, Gandhi S, Talke P, Maties O, Siegmueller C, Magsaysay A, Hasen D, Kunwar S, Seth R, Gibson L, Bickler P. Bilateral Superficial Trigeminal Nerve Blocks are not More Effective than a Placebo in Abolishing Post-operative Headache Pain in Pituitary Transsphenoidal Neurosurgery: A Prospective, Randomized, Doubleblinded Clinical Trial. Rev Recent Clin Trials. 2023;18(3):228-237. doi: 10.2174/1574887118666230227113217.

Reference Type: DERIVED

PMID: 36843368 (View on PubMed)

Other Identifiers

15-15700

Identifier Type: -

Identifier Source: org_study_id