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| Name | Class |
|---|---|
| Vejle Hospital | OTHER |
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The goal of this randomized clinical trial is to investigate the postoperative recovery following hip and knee arthroplasty procedures depending on the use of either spinal anaesthesia (SA) or general anaesthesia (GA).
The main questions are:
Participants, scheduled for total hip, total knee and unicomartmental knee arthroplasty, will be randomized to recieve spinal anaesthesia or general anaesthesia in relation to surgery. At 6 hours postoperatively a physiotherapist will conduct a 5-meter walking test to evaluate whether the participant can be safely mobilized.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spinal Anaesthesia (SA) | Experimental | Patients undergoing total hip, total knee or unicompartmental knee arthroplasty are anaesthetized using: Plain or heavy Bupivacaine hydrochloride 10 mg (2 mL) |
|
| General Anaesthesia (GA) | Experimental | Patients undergoing total hip, total knee or unicompartmental knee arthroplasty are anaesthetized using: Propofol (induction: 1.0-2.0 mg/kg. infusion: 3-5 mg/kg/hour) + Remifentanil (induction: 3-5 mcg/kg, infusion: 0.5 mcg/kg/min) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spinal anesthesia | Drug | plain or heavy Bupivacaine hydrochloride 10 mg (2 mL) injected in the spinal canal |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ability to be mobilsed safely within 6 hours of surgery | 5-meter walking test where a physiotherapist evaluates whether the participant can be safely mobilized within 6 hours of surgery. | within 6 hours postoperatively. |
| Measure | Description | Time Frame |
|---|---|---|
| Fulfilment of discharge criteria | Dichotomous (Yes or No) | On the day of surgery: at 4 hours postoperatively and 6 hours postoperatively. From postoperative day 1 and until discharge (on average 1 day): at 10.00 and at 18.00. This will be asses as long as the patient is admitted. |
| Pain score |
| Measure | Description | Time Frame |
|---|---|---|
| Vital signs - systolic blood pressure | Systolic blood pressure (mmHg). | On the day of surgery: at 4 hours postoperatively and 6 hours postoperatively. From postoperative day 1 and until discharge (on average 1 day): at 10.00 and at 18.00. This will be asses as long as the patient is admitted. |
| Vital signs - diastolic blood pressure |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anders Troelsen, MD, DMSc | Hvidovre University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Christian Bredgaard Jensen | Hvidovre | 2650 | Denmark | |||
| Vejle Hospital |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 28, 2024 | Oct 28, 2024 | SAP_000.pdf |
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| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D000775 | Anesthesia, Spinal |
| D000768 | Anesthesia, General |
| ID | Term |
|---|---|
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
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Each of the three arthroplasty procedures are investigated in a 2-arm randomised trial:
Total hip arthroplasty - either spinal anaesthesia or general anaesthesia.
Total knee arthroplasty - either spinal anaesthesia or general anaesthesia.
Unicompartmental knee arthroplasty - either spinal anaesthesia or general anaesthesia.
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Physcians and nurses in the surgical department are not able to be blinded. But outcome assesors (ie. physiotherapists, research personel) are not aware of the treatment allocation.
| General anaesthesia | Drug | Propofol (induction: 1.0-2.0 mg/kg. infusion: 3-5 mg/kg/hour) + Remifentanil (induction: 3-5 mcg/kg, infusion: 0.5 mcg/kg/min) given intravenously |
|
Will be recorded during rest and 5-m walk using participant evaluated NRS of 0 to 10, with 10 being worst pain/dizziness/nausea imaginable. This will be recorded at 4 and 6 hours post-operatively on the day of surgery and at 10:00 and 18:00 on the following postoperative days. |
| On the day of surgery: at 4 hours postoperatively and 6 hours postoperatively. From postoperative day 1 and until discharge (on average 1 day): at 10.00 and at 18.00. This will be asses as long as the patient is admitted. |
| Opioid use in Morphine Milligram Equivilents within the first 6 hours of surgery | Cumulated opioid use in Morphine Milligram Equivalents. | On the day of surgery: Within the first 6 hours after surgery. |
| Nausea Score | Will be recorded during rest and 5-m walk using participant evaluated NRS of 0 to 10, with 10 being worst pain/dizziness/nausea imaginable. This will be recorded at 4 and 6 hours post-operatively on the day of surgery and at 10:00 and 18:00 on the following postoperative days. | On the day of surgery: at 4 hours postoperatively and 6 hours postoperatively. From postoperative day 1 and until discharge (on average 1 day): at 10.00 and at 18.00. This will be asses as long as the patient is admitted. |
Diastolic blood pressure (mmHg). |
| On the day of surgery: at 4 hours postoperatively and 6 hours postoperatively. From postoperative day 1 and until discharge (on average 1 day): at 10.00 and at 18.00. This will be asses as long as the patient is admitted. |
| Quality of Recovery-15 score | Four hours postoperatively on the day of surgery and at 10:00 on the following | On the day of surgery: at 4 hours postoperatively. From postoperative day 1 and until discharge (on average 1 day): at 10.00. This will be asses as long as the patient is admitted. |
| Vejle |
| 7100 |
| Denmark |
| D012216 |
| Rheumatic Diseases |