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

• ClinicalTrials.gov Identifier: NCT03925207
• Recruitment Status: Completed
• First Posted: April 24, 2019
• Last Update Posted: December 19, 2020
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Information provided by (Responsible Party): Second Affiliated Hospital, School of Medicine, Zhejiang University

Study Description

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.

Condition or disease
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 Design

• Study Type: Observational
• Actual Enrollment: 300 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Retrobulbar Block and/or General Anesthesia for Orbital Ball Implants After Enucleation Surgery.: a Retrospective Observational Study
• Actual Study Start Date: June 28, 2019
• Actual Primary Completion Date: December 28, 2019
• Actual Study Completion Date: July 18, 2020

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Postoperative nausea and vomiting [ Time Frame: through study completion, an average of 24 hours ]
   Rate of postoperative nausea and vomiting

Eligibility Criteria

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

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.

Contacts and Locations

Locations

China

叶伟娣

Hangzhou, China

Weidi Ye

Hanzhou, China

Sponsors and Collaborators

Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

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

More Information

• Responsible Party: Second Affiliated Hospital, School of Medicine, Zhejiang University
• ClinicalTrials.gov Identifier: NCT03925207
• Other Study ID Numbers: 2019-2-18
• First Posted: April 24, 2019
• Last Update Posted: December 19, 2020
• Last Verified: December 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Second Affiliated Hospital, School of Medicine, Zhejiang University:

retrobulbar block; general anesthesia