Efficacy of Ropivacaine Wound Infiltration for Postoperative Pain Management After Minimally Invasive Aortic Valve Surgery
Overview
- Phase
- Not Applicable
- Intervention
- Piritramid
- Conditions
- Aortic Valve Surgery
- Sponsor
- University Medical Centre Ljubljana
- Enrollment
- 76
- Locations
- 1
- Primary Endpoint
- Comparison of cumulative postoperative dose of Piritramid between the two different protocols, using VAS scale to determine level of analgesia.
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The study evaluates the efficacy of local anesthestic application through the catheter in the surgical wound for the postoperative pain relief after minimally invasive aortic valve surgery. The patients will be enrolled in two different groups according to the protocol of the local anesthetic and saline administration:
- group: continous infusion of the local anesthetic plus bolus on demand
- group: continous infusion of saline plus bolus on demand For all patients metamizol every 12 hours plus bolous of piritramid on demand.
Detailed Description
Patients undergoing minimally invasive aortic valve replacment surgery will be enroled in the study, after giving a signed informed consent. The study evaluates the efficacy of local anesthestic application through the catheter in the surgical wound for the postoperative pain relief after minimally invasive aortic valve surgery. Patients will then be randomised in two groups according to the protocol: 1. group: continous infusion of the local anesthetic plus bolus on demand 2. group: continous infusion of saline plus bolus on demand All patients will receive Metamizol every 12 hours plus bolus of piritramid on demand. Analgesia effectivness will be checked hourly according to the visual analogue scale (VAS). According to protocol, bolus will be given every time the score of VAS scale is \>3. The catheter will be removed 48 hours after the protocols' start.
Investigators
Maja Sostaric
asoc. prof.
University Medical Centre Ljubljana
Eligibility Criteria
Inclusion Criteria
- •Patients after minimally invasive aortic valve surgery
- •Patients agreement with the study
Exclusion Criteria
- •Age under 18 years
- •Allergy to local anesthetic
Arms & Interventions
Ropivacaine continous infusion
Piritramid
Intervention: Piritramid
Saline continous
Piritramid
Intervention: Piritramid
Saline continous
Piritramid
Intervention: Saline
Outcomes
Primary Outcomes
Comparison of cumulative postoperative dose of Piritramid between the two different protocols, using VAS scale to determine level of analgesia.
Time Frame: 48 hours after admission to the intensive care unit (ICU)
Comparison of cumulative postoperative dose of Piritramid between the two protocols
Secondary Outcomes
- Hospital lenght of stay(Up to 30 days)
- Patients satisfaction with pain relief measured by Likert-type Patient satisfaction scale(72 hours after surgery)
- Visual analogue scale (VAS), frequency of scores higher than 3(48 hours after admission to the ICU)
- Rate of complications related to the local anesthetic(72 hours after surgery)
- Complications related to the catheter in the surgical wound(Up to 30 days)