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

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

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.

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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

Resource links provided by the National Library of Medicine





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



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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03925207


Locations
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China
叶伟娣
Hangzhou, China
Weidi Ye
Hanzhou, China
Sponsors and Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
Investigators
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Study Chair: Zhiying Wu, Doctor Second Affiliated Hospital, School of Medicine, Zhejiang University
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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    Key Record Dates
Last Update Posted: December 19, 2020
Last Verified: December 2020

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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