Osteoarthritis
Conditions
Keywords
anaesthetic techniques, subarachnoid, analgesia
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
Interventions
DRUGGA-arm, remifentanil
Remifentanil and propofol will be delivered intravenously via TCI pumps according to the Marsh and Minto algorithm
DRUGRA-arm
Intrathecal (i.e. spinal) anesthesia with isobaric bupivacaine 15 mg administered intrathecally at L4-L5.
Sponsors
Region Skane
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
46 Years to 84 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of Hospital Stay | 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
| Measure | Time frame | Description |
|---|---|---|
| Post Operative Pain | from end of surgey until 48 hrs later | 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Time Hrs Until the Patient Meets the Discharge Criteria From PACU | 12 hrs | Hours until the patient meets the discharge criteria from PACU will be monitored every 15 min from teh time the patient arrives to PACU until he/she meets the discharge criteria |
Countries
Sweden
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| RA-arm RA-arm: the patients in this arm will receive intrathecal anaesthesia consisting of bupivacaine 15 mg
placebo | 60 |
| GA-arm, Remifentanil GA-arm: patients in this arm will receive general anaesthesia consisting of Target Controlled Infusion (TCI) of remifentanil and propofol
GA-arm, remifentanil: Remifentanil and propofol will be delivered intravenously via TCI pumps according to the Marsh and Minto algorithm | 60 |
| Total | 120 |
Baseline characteristics
| Characteristic | GA-arm, Remifentanil | RA-arm | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 20 Participants | 20 Participants | 40 Participants |
| Age, Categorical Between 18 and 65 years | 40 Participants | 40 Participants | 80 Participants |
| Age, Continuous | 66 years STANDARD_DEVIATION 8 | 68 years STANDARD_DEVIATION 9 | 67 years STANDARD_DEVIATION 8 |
| Region of Enrollment Sweden | 60 participants | 60 participants | 120 participants |
| Sex/Gender, Customized Female | 31 participants | 29 participants | 60 participants |
| Sex/Gender, Customized Male | 29 participants | 31 participants | 60 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 60 | 0 / 60 |
| other Total, other adverse events | 1 / 60 | 1 / 60 |
| serious Total, serious adverse events | 0 / 60 | 0 / 60 |
Outcome results
Primary
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
Population: Two patients in the RA group were excluded because of the conversion to general anaesthesia.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| RA-arm | Length of Hospital Stay | 30 hours |
| GA-arm, Remifentanil | Length of Hospital Stay | 26 hours |
Secondary
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
Population: Two patients in the RA group were excluded because of the conversion to general anaesthesia.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| RA-arm | Post Operative Pain | 35 score on a scale |
| GA-arm, Remifentanil | Post Operative Pain | 25 score on a scale |
Other Pre-specified
Time Hrs Until the Patient Meets the Discharge Criteria From PACU
Hours until the patient meets the discharge criteria from PACU will be monitored every 15 min from teh time the patient arrives to PACU until he/she meets the discharge criteria
Time frame: 12 hrs
Population: Two patients in the RA group were excluded because of the conversion to general anaesthesia.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| RA-arm | Time Hrs Until the Patient Meets the Discharge Criteria From PACU | 4 hours |
| GA-arm, Remifentanil | Time Hrs Until the Patient Meets the Discharge Criteria From PACU | 3 hours |