Preemptive Low-dose Epidural Ketamine for Preventing Chronic Post-thoracotomy Pain

Chronic Post-thoracotomy Pain Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01017393
• Other study ID #: JHBahk_epidural ketamine PTPS
• Status: Completed
• Phase: N/A
• First received: November 19, 2009
• Last updated: November 19, 2009
• Start date: April 2004
• Est. completion date: June 2005

Study information

• Verified date: November 2009
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Chronic post-thoracotomy pain is the most common long-term complication that occurs after a thoracotomy with a reported incidence of up to 80%. While thoracic epidural analgesia has become the mainstay for managing acute post-thoracotomy pain, its effect on the chronic post-thoracotomy pain seems questionable. The objective of this prospective, double-blinded, randomized, controlled trial was to assess the effect of preemptive low-dose epidural ketamine in addition to preemptive thoracic epidural analgesia on the incidence of chronic post-thoracotomy pain.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 209
• Est. completion date: June 2005
• Est. primary completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 81 Years

Eligibility

Inclusion Criteria:

• Patients undergoing surgery with a thoracotomy incision

Exclusion Criteria:

• history of previous thoracic surgery, chronic pain, psychiatric disease, cardiac or vascular disease, neurologic deficits, or contraindications to epidural catheterization such as coagulopathy, or localized or systemic infection

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chronic Post-thoracotomy Pain

Intervention

Drug:
• Ketamine

• ketamine free

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of pain 3 months after surgery		3 months after surgery	No