Pain Prevalence After Major Craniotomy

Pain Prevalence After Major Craniotomy in Siriraj Hospital

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

Study Overview

• Status: Completed
• Conditions: Pain; Craniotomy

• Study Type: Observational
• Enrollment (Actual): 302

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10700
    • Sirilak Suksompong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patient undergoing cranitomy

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
incidence of moderate to severe pain following major craniotomy	48 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
risk factors of moderate to severe pain following craniotomy.	48 hours

Collaborators and Investigators

• Sponsor: Mahidol University

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (ACTUAL): January 1, 2013
• Study Completion (ACTUAL): January 1, 2013

Study Registration Dates

• First Submitted: December 29, 2011
• First Submitted That Met QC Criteria: December 29, 2011
• First Posted (ESTIMATE): December 30, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): January 15, 2013
• Last Update Submitted That Met QC Criteria: January 13, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: pain; craniotomy
• Other Study ID Numbers: Si223/2011; 161/2554(EC1) (OTHER: Faculty of Medicine, Siriraj Hospital)