Epidural Versus Continuous Wound Ropivacaine Infusion Analgesia

Postoperative Analgesia Clinical Trial

Official title:

Epidural Versus Continuous Wound Ropivacaine Infusion: Effect on Acute and Chronic Pain After Myomectomy or Total Abdominal Hysterectomy. A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01916473
• Other study ID #: M-20/23-02-2010
• Status: Completed
• Phase: N/A
• First received: July 15, 2013
• Last updated: August 1, 2013
• Start date: April 2010
• Est. completion date: November 2012

Study information

• Verified date: August 2013
• Source: University of Athens
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Interventional

Clinical Trial Summary

Study Hypothesis: The analgesic requirements and pain scores postoperatively differ between the epidural and continuous wound infusion techniques.

Description:

The analgesic requirements and pain scores postoperatively differ between the epidural and continuous wound infusion techniques, in patients undergoing myomectomy or hysterectomy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 60 Years

Eligibility

Inclusion Criteria:

Patients ASA I-II scheduled for abdominal hysterectomy or myomectomy -

Exclusion Criteria:

Age older than 60 and younger than 25 years, body weight exceeding the 30% of the ideal, consumption of analgesics, sedatives, anxiolytics, antidepressants, calcium channel blockers, CNS disease or insulin dependent diabetes

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Postoperative Analgesia

Intervention

Other:
• Epidural analgesia
Epidural analgesia is provided with ropvacaine 0.2% given 6 hourly
• Continuous wound infusion
Continuous wound infusion via catheter

Locations

Country	Name	City	State
Greece	Aretaieio Hospital	Athens

Sponsors (1)

Lead Sponsor	Collaborator
University of Athens

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative morphine consumption		2 hours postoperatively	Yes
Primary	Postoperative morphine consumption		4 hours postoperatively	Yes
Primary	Postoperative morphine consumption		8 hours postoperatively	Yes
Primary	Postoperative morphine consumption		24 hours postoperatively	Yes
Primary	Postoperative morphine consumption		48 hours postoperatively	Yes
Primary	Postoperative morphine consumption		72 hours postoperatively	Yes
Primary	Postoperative morphine consumption		3 months postoperatively	Yes
Primary	Postoperative morphine consumption		6 months postoperatively	Yes
Secondary	pain scores		2 hours postoperatively	Yes
Secondary	pain scores		4 hours postoperatively	Yes
Secondary	pain scores		8 hours postoperatively	Yes
Secondary	pain scores		24 hours postoperatively	Yes
Secondary	pain scores		48 hours postoperatively	Yes
Secondary	pain scores		72 hours postoperatively	Yes
Secondary	pain scores		3 months postoperatively	Yes
Secondary	pain scores		6 months postoperatively	Yes