General Versus Intrathecal Anaesthesia for Patients Undergoing Elective Total Hip Arthroplasty
Overview
- Phase
- Not Applicable
- Intervention
- RA-arm
- Conditions
- Osteoarthritis
- Sponsor
- Region Skane
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Length of Hospital Stay
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
The purpose of this study is to determine whether general anaesthesia or regional anaesthesia is best for patients undergoing Total Hip Arthroplasty.
Detailed Description
A randomized controlled trial (RCT) with a follow up time of 48 hrs. Patients scheduled for primary Total Hip Arthroplasty. A total of 120 patients randomly assigned to one of the two alternatives (general anaesthesia (GA) or regional anaesthesia (RA)). General anaesthesia compared to intrathecal anaesthesia will give shorter length of hospital stay (LOS) for patients undergoing total hip arthroplasty (THA). Primary endpoint: LOS. Secondary endpoints: Postoperative pain? Postoperative orthostatic function (dizziness) Time until the patient meets the discharge criteria from PACU How many patients will need at least one urinary bladder catheterisation
Investigators
Andreas Harsten
M.D.
Region Skane
Eligibility Criteria
Inclusion Criteria
- •patients with osteoarthritis scheduled for surgery
- •patients that will require THA
- •patients over 45 yrs and under 85 yrs.
- •patients that understand the given information and are willing to participate in this study
- •patients who have signed the informed consent document.
- •patients belonging to ASA class I-III.
Exclusion Criteria
- •prior surgery to the same hip
- •patients with a history of stroke, neurological or psychiatric disease that potentially could affect the perception of pain
- •obesity (BMI \> 35)
- •active or suspected infection
- •patients taking opioids or steroids
- •patients suffering from rheumatoid arthritis or an immunological depression
- •patients who are allergic to any of the drugs being used in this study
Arms & Interventions
RA-arm
RA-arm: the patients in this arm will receive intrathecal anaesthesia consisting of bupivacaine 15 mg
Intervention: RA-arm
GA-arm, remifentanil
GA-arm: patients in this arm will receive general anaesthesia consisting of Target Controlled Infusion (TCI) of remifentanil and propofol
Intervention: GA-arm, remifentanil
Outcomes
Primary Outcomes
Length of Hospital Stay
Time Frame: Up to 4 days after surgery
Time from the end of surgery until the patients meets the discharge criteria will be evaluated. Discharge criteria: able to get in and out of bed, Able to get dressed. Able to sit down in a chair and get up again. Able to walk 50 meters wit/without crutches. Able to flex knee 70 degrees. Able to walk stairs. Pain manageable with oral analgesics. Acceptance to be discharged
Secondary Outcomes
- Post Operative Pain(from end of surgey until 48 hrs later)