Pain Prevalence After Major Craniotomy

January 13, 2013 updated by: Sirilak Suksompong, Mahidol University

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

Study Type

Observational

Enrollment (Actual)

302

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10700
        • Sirilak Suksompong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Other Study ID Numbers

  • Si223/2011
  • 161/2554(EC1) (OTHER: Faculty of Medicine, Siriraj Hospital)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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