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

NCT ID: NCT03925207

Last Updated: 2020-12-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-06-28
• Study Completion Date: 2020-07-18

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.

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.

Conditions

Enucleated; Eye

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zhiying Wu, Doctor

Role: STUDY_CHAIR

Second Affiliated Hospital, School of Medicine, Zhejiang University

Locations

叶伟娣

Hangzhou, , China

Weidi Ye

Hanzhou, , China

Countries

China

Other Identifiers

2019-2-18

Identifier Type: -

Identifier Source: org_study_id