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

NCT03925207 | Completed DMC

• 1 other identifier: 2019-2-18
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Enucleated; Eye

Keywords

retrobulbar block; general anesthesia

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Postoperative nausea and vomiting

  through study completion, an average of 24 hours

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (2)

叶伟娣

Hangzhou, China

Location

Weidi Ye

Hanzhou, China

Location

Study Officials

• Zhiying Wu, Doctor

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2019
• First Posted: April 24, 2019
• Study Start: June 28, 2019
• Primary Completion: December 28, 2019
• Study Completion: July 18, 2020
• Last Updated: December 19, 2020

Record last verified: 2020-12

Locations

CN (2)