Retrobulbar Block and/or General Anesthesia for Orbital Ball Implants After Enucleation Surgery. (pprb)

Retrobulbar Block and/or General Anesthesia for Orbital Ball Implants After Enucleation Surgery.: a Retrospective Observational Study

Retrobulbar block is used to provide perioperative analgesia and anesthesia for orbital ball implants after enucleation surgery in the investigator's hospital. Retrobulbar block alone can provide quicker recovery, decreased time to discharge, opioid sparing, reduced costs. However, patients undergoing orbital ball implants after enucleation surgery with retrobulbar block alone suffered more preoperative and intraoperative anxiety，postoperative pain, and postoperative nausea and vomiting. General anesthesia alone is administered to patients undergoing orbital ball implants after enucleation surgery and opioids are used in adjunct with general anesthesia to suppress pain and hemodynamic stress associated with surgical trauma. GA only associated with more systemic opioids, short-term cognitive impairment, somnolence, and postoperative nausea and vomiting that can increase patient morbidity and delay discharge. Opioids, however, can result in adverse effects such as nausea and vomiting, pruritus, sedation. As a result of this growing demand of efficient and effective anesthesia management for orbital ball implants after enucleation surgery is becoming increasingly important. Numerous studies have reported benefits of an retrobulbar block for orbital ball implants after enucleation surgery, including quicker recovery and decreased time to discharge, decreased pain scores, opioid sparing, reduced costs, less intraoperative hemodynamic variability, improved patient satisfaction, and, in some cases, reduced GA- and/or opioid-related side effects. A recent systematic review examining all modes of postoperative pain management following orbital ball implants after enucleation surgery concluded that retrobulbar block are superior to all other forms of postoperative pain control.

Study Overview

• Status: Completed
• Conditions: Enucleated; Eye

Detailed Description

This retrospective review examined postoperative outcomes for orbital ball implants after enucleation surgery patients who underwent surgery with general anesthesia (GA), single-shot retrobulbar block, or retrobulbar block combined with GA. The primary outcome included postoperative pain upon arrival at and discharge from the PACU, analgesic consumption and rescue analgesia. Secondary outcomes was time to discharge from the postanesthesia care unit (PACU) as well as GA and opioid-related side effects and retrobulbar block- associated neurological complications. The investigators speculated that patients who received an retrobulbar block before GA had less postoperative pain, and reduced analgesic requirements when compared with patients who received GA Only or retrobulbar block alone.

• Study Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• China
  • Hangzhou, China
    • 叶伟娣
  • Hanzhou, China
    • Weidi Ye

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients were included if they underwent orbital ball implants after enucleation surgery by one ophthalmologist surgeon specializing in oculoplastic and orbital surgery at our centre above 18 years old

Description

Inclusion Criteria:

• Patients were included if they underwent orbital ball implants after enucleation surgery by one ophthalmologist surgeon specializing in oculoplastic and orbital surgery at our centre.

Exclusion Criteria:

• Patients were excluded if they underwent other concurrent surgical procedures, or were under 18 yr of age.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative pain upon arrival at and discharge from the postanesthesia care unit	Visual Analogue Scale score（0-10, no pain - worse） of postoperative pain,	through study completion: an average of 24 hour
analgesic consumption	Dose of analgesic consumption	through study completion: an average of 24 hours
rescue analgesia	Rate of rescue analgesia	through study completion, an average of 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative nausea and vomiting	Rate of postoperative nausea and vomiting	through study completion, an average of 24 hours

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Study Chair: Zhiying Wu, Doctor, Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2019
• Primary Completion (Actual): December 28, 2019
• Study Completion (Actual): July 18, 2020

Study Registration Dates

• First Submitted: February 26, 2019
• First Submitted That Met QC Criteria: April 21, 2019
• First Posted (Actual): April 24, 2019

Study Record Updates

• Last Update Posted (Actual): December 19, 2020
• Last Update Submitted That Met QC Criteria: December 16, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: general anesthesia; retrobulbar block
• Other Study ID Numbers: 2019-2-18

Drug and device information, study documents

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