Propofol Versus Volatile Anesthesia in Post Operative Pain Management

Postoperative Pain Clinical Trial

Official title:

Do Patients Anesthetized With Propofol Have Less Pain Than Those Anesthetized With Volatile?

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00712517
• Other study ID #: 42908
• Status: Terminated
• Phase: N/A
• First received: July 7, 2008
• Last updated: July 18, 2016
• Start date: September 2010
• Est. completion date: May 2014

Study information

• Verified date: July 2016
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial Summary

The study will test the hypothesis that patients anesthetized with propofol suffer less postoperative pain than those anesthetized with sevoflurane.

Description:

Patients undergoing s stripping operation for varicose veins will be randomized to one of two groups. Group 1 patients will receive propofol anesthesia. Group 2 patients will receive sevoflurane anesthesia. Intraoperative measurements including mean-arterial pressure, heart rate, propofol infusion rate, remifentanil infusion rate, and end-tidal sevoflurane concentration will be taken at 15 minute intervals. Patients in both groups will receive Piritramid as necessary to control pain either intravenously or through patient controlled pump. VAS pain score, mean-arterial pressure, heart rate, nausea will be evaluated at 30 minute intervals during the first four postoperative hours. Piritramid dosage and vomiting will be recorded through the first postoperative morning. Patients will rate pain based on the VAS score for the period between leaving the recovery room and the first postoperative morning

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 90
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participants will undergo a stripping operation for varicose veins

• Surgery will be performed by one physician only

• Written informed consent

Exclusion Criteria:

• Any contraindications to the proposed interventions

• Procedures done under regional anesthesia

Study Design

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain
• Varicose Vein
• Varicose Veins

Intervention

Drug:
• propofol
propofol anesthesia 3-5mg/kg
• sevoflurane
sevoflurane anesthesia

Locations

Country	Name	City	State
Austria	Olga Plattner , MD	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome is morphine-equivalent use from the end of surgery until the first post-operative morning.		first post operative morning	No
Secondary	To determine the average pain score for each group during the first four hours of recovery after surgery.		30 minute intervals for first 4 hours post operatively	No