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Pain Prevalence After Major Craniotomy

Sponsor
Mahidol University (Other)
Overall Status
Completed
CT.gov ID
NCT01502540
Collaborator
(none)
302
Enrollment
1
Location
27
Duration (Months)
11.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Craniotomies are generally thought to be less painful than other operations. Indeed recent studies have confirmed that pain is a common problem during the postoperative phase following craniotomy.Pain not only causes discomfort, but it is also associated with other potential adverse events such as increased sympathetic activity and elevated systemic blood pressure. These events in turn may contribute to increased intracranial pressure. Some patients may also develop chronic pain.Potent opioids have been avoided due to its potential to cause respiratory depression and risk of masking pupillary signs. As a result postoperative craniotomy pain controls are usually inadequate.

In Siriraj hospital, there are 500-600 craniotomy patients per year. Still there are no definite guidelines for postoperative pain management in these patents due to lack of information about quality of postoperative pain control after craniotomy.

Objectives

Primary objective :
  • To study incidence of moderate to severe pain during first 48 hours after craniotomy.
Secondary objectives :

  • To determine risk factors for moderate to severe pain during first 48 hours after craniotomy

  • To evaluate side effects and complications of postoperative craniotomy pain control

  • To compare patient's expectation for pain management before and after surgery

  • To determine patient's satisfaction for postoperative pain management

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    302 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Pain Prevalence After Major Craniotomy in Siriraj Hospital
    Study Start Date :
    Oct 1, 2010
    Actual Primary Completion Date :
    Jan 1, 2013
    Actual Study Completion Date :
    Jan 1, 2013

    Outcome Measures

    Primary Outcome Measures

    1. incidence of moderate to severe pain following major craniotomy [48 hours]

    Secondary Outcome Measures

    1. risk factors of moderate to severe pain following craniotomy. [48 hours]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patient undergoing major craniotomy (supratentorial surgery and Infratentorial surgery)

    • Age > 18 years

    Exclusion Criteria:

    • Emergency or trauma

    • Need postoperative ventilatory support

    • Cannot communication

    • Psychosis

    • Not adherence to the treatment protocol

    • History of using benzodiazepine or addictive substance

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sirilak Suksompong Bangkok Thailand 10700

    Sponsors and Collaborators

    • Mahidol University

    Investigators

    • Principal Investigator: Sirilak Suksompong, MD, Mahidol University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sirilak Suksompong, Associate Professor, Mahidol University
    ClinicalTrials.gov Identifier:
    NCT01502540
    Other Study ID Numbers:
    • Si223/2011
    • 161/2554(EC1)
    First Posted:
    Dec 30, 2011
    Last Update Posted:
    Jan 15, 2013
    Last Verified:
    Jan 1, 2013
    Keywords provided by Sirilak Suksompong, Associate Professor, Mahidol University
    pain
    craniotomy

    Study Results

    No Results Posted as of Jan 15, 2013