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NCT Number: NCT03422887

Nalbuphine and Flurbiprofen for Oculoplastic Surgery

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

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Key information

Conditions

Surgery Anesthesia Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

16 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

About this study

In this randomized controlled clinical trial, we evaluated the postoperative analgesic efficacy and adverse effects of flurbiprofen axetil combined with nalbuphine in patients undergoing oculoplastic surgery compared with a single dose of flurbiprofen axetil or nalbuphine.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Undergoing oculoplastic surgery
  • age between 16 and 75 years
  • American Society of Anesthesiologists (ASA) physical status of I-II

Exclusion criteria

  • serious coexisting disease
  • body mass index (BMI) <18.5 or >35
  • contraindications or previous adverse reactions to any of the drugs used
  • females with a positive pregnancy test
  • patients unable to cooperate

Treatment and study plan

Nalbuphine

Drug

Nalbuphine administration during surgery

Flurbiprofen Axetil

Drug

Flurbiprofen axetil administration during surgery

Nalbuphine and Flurbiprofen Axetil

Drug

Nalbuphine and Flurbiprofen Axetil administration during surgery

Primary outcomes

  1. Pain 24 hours after recovery

    Time frame: 24 hours 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 outcomes

  1. Discomfort 24 hours after recovery

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

Flurbiprofen Axetil and Nalbuphine for Postoperative Pain and Discomfort After Oculoplastic Surgery

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 6, 2018
Registry last updated
Feb 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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