General or Regional Anesthesia for Hip Surgery

Region Skane120 enrolled

Overview

The purpose of this study is to determine whether general anaesthesia or regional anaesthesia is best for patients undergoing Total Hip Arthroplasty.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

120

Conditions

Osteoarthritis

Interventions

GA-arm, remifentanilDRUG

Remifentanil and propofol will be delivered intravenously via TCI pumps according to the "Marsh" and "Minto" algorithm

RA-armDRUG

Intrathecal (i.e. spinal) anesthesia with isobaric bupivacaine 15 mg administered intrathecally at L4-L5.

Eligibility

Sex: ALLMin age: 46 YearsMax age: 84 Years

Medical Language ↔ Plain English

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

Locations (1)

Dept Orthopedic Surgey, Hässleholm Hospital, PO Box 351,

Hässleholm, Sweden

Outcomes

Primary Outcomes

Length of Hospital Stay

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

Time frame: Up to 4 days after surgery

Secondary Outcomes

Post Operative Pain

Pain will be monitored using a Visual Analogue Scale. Pain will be monitored with the patient in four different positions. VAS 100 mm used for assessment of pain (0 = no pain, 100 = worst imaginable pain). At each time and position the median VAS-pain score was reported (generally the distribution of pain scores are not normally distributed and hence median value was used)

Time frame: from end of surgey until 48 hrs later

Data from ClinicalTrials.gov

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