Postoperative Pain and Discomfort After Orbital Decompression

Sponsor

Sun Yat-sen University (Other)

Overall Status

Completed

CT.gov ID

NCT03562611

Collaborator

(none)

Enrollment

Location

Arms

3.7

Actual Duration (Months)

16.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Surgery Anesthesia Pain	Drug: Nalbuphine Drug: Flurbiprofen Axetil Drug: Nalbuphine and Flurbiprofen Axetil	N/A

Detailed Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

63 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Flurbiprofen Axetil and Nalbuphine for Postoperative Pain and Discomfort After Orbital Decompression

Actual Study Start Date :

Jun 8, 2018

Actual Primary Completion Date :

Sep 8, 2018

Actual Study Completion Date :

Sep 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: flurbiprofen axetil flurbiprofen axetil intraoperative administration 100mg	Drug: Flurbiprofen Axetil Flurbiprofen axetil administration during surgery
Experimental: nalbuphine nalbuphine intraoperative administration 0.1mg/kg	Drug: Nalbuphine Nalbuphine administration during surgery
Experimental: nalbuphine and flurbiprofen axetil flurbiprofen axetil intraoperative administration 100mg and nalbuphine intraoperative administration 0.1mg/kg	Drug: Nalbuphine and Flurbiprofen Axetil Nalbuphine and Flurbiprofen Axetil administration during surgery

Arm

Intervention/Treatment

Active Comparator: flurbiprofen axetil

flurbiprofen axetil intraoperative administration 100mg

Drug: Flurbiprofen Axetil

Flurbiprofen axetil administration during surgery

Experimental: nalbuphine

nalbuphine intraoperative administration 0.1mg/kg

Drug: Nalbuphine

Nalbuphine administration during surgery

Experimental: nalbuphine and flurbiprofen axetil

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

Drug: Nalbuphine and Flurbiprofen Axetil

Nalbuphine and Flurbiprofen Axetil administration during surgery

Outcome Measures

Primary Outcome Measures

Pain after orbital decompression [24 hour after recovery]
Pain levels measured using Numerical Rating Scale (NRS) ranging from 0 to 10, where 0 represents no pain and 10 represents the worst pain imaginable ; this scale has been confirmed to be sensitive and reliable.Clinically significant postoperative pain was considered serious pain (NRS score ≥5).

Secondary Outcome Measures

Discomfort after orbital decompression [24 hour after recovery]
Discomfort levels were measured using Numerical Rating Scale (NRS) ranging from 0 to 10, where 0 represents no discomfort and 10 represents the worst discomfort; this scale has been confirmed to be sensitive and reliable. Discomfort was defined as "sensation other than pain" and included nausea, vomiting, headache, and dizziness. Clinically significant postoperative discomfort was considered serious discomfort (NRS score ≥5) any time postoperatively.

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sun Yat-sen University	Guangzhou	Guangdong	China	510000

Sponsors and Collaborators

Sun Yat-sen University

Investigators

Principal Investigator: Huijing Ye, Sun Yat-sen University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Huijing Ye, Principal Investigator, Sun Yat-sen University

ClinicalTrials.gov Identifier:

NCT03562611

Other Study ID Numbers:

201806

First Posted:

Jun 19, 2018

Last Update Posted:

Dec 26, 2018

Last Verified:

Dec 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Huijing Ye, Principal Investigator, Sun Yat-sen University

postoperative pain

general anesthesia

postoperative discomfort

Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 26, 2018