Pain Prevalence After Major Craniotomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sirilak Suksompong, Mahidol University
ClinicalTrials.gov Identifier:
NCT01502540
First received: December 29, 2011
Last updated: January 13, 2013
Last verified: January 2013
  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 Mahidol University:

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

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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01502540

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

No publications provided

Responsible Party: Sirilak Suksompong, Associate Professor, Mahidol University
ClinicalTrials.gov Identifier: NCT01502540     History of Changes
Other Study ID Numbers: Si223/2011, 161/2554(EC1)
Study First Received: December 29, 2011
Last Updated: January 13, 2013
Health Authority: Thailand: Ethical Committee

Keywords provided by Mahidol University:
pain
craniotomy

ClinicalTrials.gov processed this record on August 28, 2014