Pain Prevalence After Major Craniotomy

Pain Clinical Trial

Official title:

Pain Prevalence After Major Craniotomy in Siriraj Hospital

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01502540
• Other study ID #: Si223/2011
• Secondary ID: 161/2554(EC1)
• Status: Completed
• Phase: N/A
• First received: December 29, 2011
• Last updated: January 13, 2013
• Start date: October 2010
• Est. completion date: January 2013

Study information

• Verified date: January 2013
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 302
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Craniotomy
• Pain

Locations

Country	Name	City	State
Thailand	Sirilak Suksompong	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of moderate to severe pain following major craniotomy		48 hours	Yes
Secondary	risk factors of moderate to severe pain following craniotomy.		48 hours	Yes