Pain Prevalence After Major Craniotomy

Completed

• Conditions: Pain; Craniotomy

• Registration Number: NCT01502540
• Lead Sponsor: Mahidol University

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2011-12-29
• Study First Submitted QC: 2011-12-29
• Study First Posted: 2011-12-30
• Status Verified: 2013-01
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Last Update Submitted: 2013-01-13
• Last Update Posted: 2013-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 302

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
incidence of moderate to severe pain following major craniotomy	48 hours

Secondary Outcome Measures

Name	Time	Method
risk factors of moderate to severe pain following craniotomy.	48 hours

Trial Locations

Locations (1)

Sirilak Suksompong; 🇹🇭 Bangkok, Thailand