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Pain Prevalence After Major Craniotomy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01502540
First Posted: December 30, 2011
Last Update Posted: January 15, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sirilak Suksompong, Mahidol University
  Purpose

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
Pain Craniotomy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pain Prevalence After Major Craniotomy in Siriraj Hospital

Further study details as provided by Sirilak Suksompong, Mahidol University:

Primary Outcome Measures:
  • incidence of moderate to severe pain following major craniotomy [ Time Frame: 48 hours ]

Secondary Outcome Measures:
  • risk factors of moderate to severe pain following craniotomy. [ Time Frame: 48 hours ]

Enrollment: 302
Study Start Date: October 2010
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patient undergoing cranitomy
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01502540


Locations
Thailand
Sirilak Suksompong
Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: Sirilak Suksompong, MD Mahidol University
  More Information

Responsible Party: Sirilak Suksompong, Associate Professor, Mahidol University
ClinicalTrials.gov Identifier: NCT01502540     History of Changes
Other Study ID Numbers: Si223/2011
161/2554(EC1) ( Other Identifier: Faculty of Medicine, Siriraj Hospital )
First Submitted: December 29, 2011
First Posted: December 30, 2011
Last Update Posted: January 15, 2013
Last Verified: January 2013

Keywords provided by Sirilak Suksompong, Mahidol University:
pain
craniotomy