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

Enucleated; Eye Clinical Trial

— pprb  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03925207
• Other study ID #: 2019-2-18
• Status: Completed
• Start date: June 28, 2019
• Est. completion date: July 18, 2020

Study information

• Verified date: December 2020
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: July 18, 2020
• Est. primary completion date: December 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Enucleated; Eye

Locations

Country	Name	City	State
China	???	Hangzhou
China	Weidi Ye	Hanzhou

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	analgesic consumption	Dose of analgesic consumption	through study completion: an average of 24 hours
Primary	rescue analgesia	Rate of rescue analgesia	through study completion, an average of 24 hours
Secondary	Postoperative nausea and vomiting	Rate of postoperative nausea and vomiting	through study completion, an average of 24 hours