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Completed

NCT Number: NCT01502540

Pain Prevalence After Major Craniotomy

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

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Key information

Conditions

Pain Craniotomy Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sirilak Suksompong

Bangkok, 10700, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. incidence of moderate to severe pain following major craniotomy

    Time frame: 48 hours

Secondary outcomes

  1. risk factors of moderate to severe pain following craniotomy.

    Time frame: 48 hours

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

Pain Prevalence After Major Craniotomy in Siriraj Hospital

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Dec 30, 2011
Registry last updated
Jan 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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