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Pain Prevalence After Major Craniotomy

M

Mahidol University

Status

Completed

Conditions

Craniotomy
Pain

Study type

Observational

Funder types

Other

Identifiers

NCT01502540
Si223/2011
161/2554(EC1) (Other Identifier)

Details and patient eligibility

About

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

Enrollment

302 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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