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Prediction of Postoperative Pain by Injection Pain of Propofol

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ClinicalTrials.gov Identifier: NCT03021447
Recruitment Status : Unknown
Verified January 2017 by Go Un Roh, Ajou University School of Medicine.
Recruitment status was:  Not yet recruiting
First Posted : January 16, 2017
Last Update Posted : January 16, 2017
Sponsor:
Information provided by (Responsible Party):
Go Un Roh, Ajou University School of Medicine

Brief Summary:

Postoperative pain is a significant postoperative problem and it could be persistent if proper management is not provided. However, each patient shows different intensity of pain and different sensitivity to analgesics even if they underwent same procedures. Therefore, it would be useful to find the way to predict the postoperative pain sensitivity.

Propofol, a popular anesthetic agent, induces pain during injection, which can not completely prevented by opioid or lidocaine in some patients. This is considered to be related to patient's pain sensitivity and it might be associated with postoperative pain sensitivity.

Therefore, the relation of propofol injection pain and postoperative pain intensity will be explored.


Condition or disease
Cholecystitis, Acute

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Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : January 2017
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. postoperative pain intensity_1 [ Time Frame: 10 min after postanesthesia care unit admission ]
    Postoperative pain will be evaluated with verbal numeric scale (0-10)


Secondary Outcome Measures :
  1. postoperative pain intensity_2 [ Time Frame: 20 min after postanesthesia care unit admission ]
    Postoperative pain will be evaluated with verbal numeric scale (0-10)

  2. postoperative pain intensity_3 [ Time Frame: 30 min after postanesthesia care unit admission ]
    Postoperative pain will be evaluated with verbal numeric scale (0-10)

  3. postoperative pain intensity_4 [ Time Frame: 4 hours after operation ]
    Postoperative pain will be evaluated with verbal numeric scale (0-10)

  4. postoperative pain intensity_8 [ Time Frame: 8 hours after operation ]
    Postoperative pain will be evaluated with verbal numeric scale (0-10)

  5. postoperative pain intensity_12 [ Time Frame: 12 hours after operation ]
    Postoperative pain will be evaluated with verbal numeric scale (0-10)

  6. postoperative pain intensity_24 [ Time Frame: 24 hours after operation ]
    Postoperative pain will be evaluated with verbal numeric scale (0-10)



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Ages Eligible for Study:   19 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients scheduled for laparoscopic cholecystectomy will be included.
Criteria

Inclusion Criteria:

  • America Society of Anesthesiologists class I-II
  • Laparoscopic cholecystectomy

Exclusion Criteria:

  • Pregnancy
  • Illiteracy

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Responsible Party: Go Un Roh, principal investigator, Ajou University School of Medicine
ClinicalTrials.gov Identifier: NCT03021447     History of Changes
Other Study ID Numbers: AJIRB-MED-OBS-16-48
First Posted: January 16, 2017    Key Record Dates
Last Update Posted: January 16, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Cholecystitis
Cholecystitis, Acute
Gallbladder Diseases
Biliary Tract Diseases
Digestive System Diseases