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

NCT04670614 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2020-12-17

No results posted yet for this study

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.

Conditions

  • Post-operative Surgical Pain

Interventions

PROCEDURE

Nerve Block with ropivicaine 0.5% Injectable Solution

Peripheral nerve blocks using 0.5% ropivicaine

PROCEDURE

Nerve Block with Placebo sham control of 0.9% Normal Saline

Peripheral Nerve Block with placebo 0.9% normal saline

Sponsors & Collaborators

Principal Investigators

  • Una Srejic, MD · University of California, San Diego

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-01-15
Primary Completion
2018-12-25
Completion
2018-12-25

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04670614 on ClinicalTrials.gov