Pain Prevalence After Major Craniotomy

NCT ID: NCT01502540

Last Updated: 2013-01-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 302 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2013-01-31

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

Conditions

Pain; Craniotomy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mahidol University

OTHER

Sponsor Role: lead

Responsible Party

Sirilak Suksompong

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sirilak Suksompong, MD

Role: PRINCIPAL_INVESTIGATOR

Mahidol University

Locations

Sirilak Suksompong

Bangkok, , Thailand

Countries

Thailand

Other Identifiers

161/2554(EC1)

Identifier Type: OTHER

Identifier Source: secondary_id

Si223/2011

Identifier Type: -

Identifier Source: org_study_id