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Postoperative Pain and Discomfort After Orbital Decompression

NCT ID: NCT03562611

Last Updated: 2018-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-08

Study Completion Date

2018-09-30

Brief Summary

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The purpose of this study is to evaluate the postoperative pain and discomfort using flurbiprofen axetil or nalbuphine administration after orbital decompression under general anesthesia.

Detailed Description

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To investigate postoperative analgesia achieved with intraoperative administration of intravenous nalbuphine and flurbiprofen axetil in patients undergoing orbital decompression

Conditions

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Surgery Anesthesia Pain

Keywords

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postoperative pain general anesthesia postoperative discomfort

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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flurbiprofen axetil

flurbiprofen axetil intraoperative administration 100mg

Group Type ACTIVE_COMPARATOR

Flurbiprofen Axetil

Intervention Type DRUG

Flurbiprofen axetil administration during surgery

nalbuphine

nalbuphine intraoperative administration 0.1mg/kg

Group Type EXPERIMENTAL

Nalbuphine

Intervention Type DRUG

Nalbuphine administration during surgery

nalbuphine and flurbiprofen axetil

flurbiprofen axetil intraoperative administration 100mg and nalbuphine intraoperative administration 0.1mg/kg

Group Type EXPERIMENTAL

Nalbuphine and Flurbiprofen Axetil

Intervention Type DRUG

Nalbuphine and Flurbiprofen Axetil administration during surgery

Interventions

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Nalbuphine

Nalbuphine administration during surgery

Intervention Type DRUG

Flurbiprofen Axetil

Flurbiprofen axetil administration during surgery

Intervention Type DRUG

Nalbuphine and Flurbiprofen Axetil

Nalbuphine and Flurbiprofen Axetil administration during surgery

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 16-75 years old
* diagnosed as thyroid eye disease
* bone removal orbital decompression under general anesthesia
* American Society of Anesthesiologists (ASA) physical status of I-II

Exclusion Criteria

* body mass index (BMI) \<18.5 or \>35
* any uncontrolled clinical problems
Minimum Eligible Age

16 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Huijing Ye

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Huijing Ye

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

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Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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201806

Identifier Type: -

Identifier Source: org_study_id