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| ID | Type | Description | Link |
|---|---|---|---|
| Hässleholm2013 | Other Identifier | Region Skåne |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RA-arm | Placebo Comparator | RA-arm: the patients in this arm will receive intrathecal anaesthesia consisting of bupivacaine 15 mg |
|
| GA-arm, remifentanil | Experimental | GA-arm: patients in this arm will receive general anaesthesia consisting of Target Controlled Infusion (TCI) of remifentanil and propofol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GA-arm, remifentanil | Drug | Remifentanil and propofol will be delivered intravenously via TCI pumps according to the "Marsh" and "Minto" algorithm |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to 4 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | from end of surgey until 48 hrs later |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 hrs |
Inclusion Criteria: patients with osteoarthritis scheduled for surgery
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andreas Harsten, M.D. | Region Skane | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept Orthopedic Surgey, Hässleholm Hospital, PO Box 351, | Hässleholm | 28125 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18211990 | Background | Fowler SJ, Symons J, Sabato S, Myles PS. Epidural analgesia compared with peripheral nerve blockade after major knee surgery: a systematic review and meta-analysis of randomized trials. Br J Anaesth. 2008 Feb;100(2):154-64. doi: 10.1093/bja/aem373. | |
| 2361330 | Background | Marsh BJ, Morton NS, White M, Kenny GN. A computer controlled infusion of propofol for induction and maintenance of anaesthesia in children. Can J Anaesth. 1990 May;37(4 Pt 2):S97. No abstract available. |
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| ID | Title | Description |
|---|---|---|
| FG000 | RA-arm | RA-arm: the patients in this arm will receive intrathecal anaesthesia consisting of bupivacaine 15 mg placebo |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | RA-arm | RA-arm: the patients in this arm will receive intrathecal anaesthesia consisting of bupivacaine 15 mg placebo |
| BG001 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Two patients in the RA group were excluded because of the conversion to general anaesthesia. | Posted | Median | Inter-Quartile Range | hours | Up to 4 days after surgery |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | RA-arm | RA-arm: the patients in this arm will receive intrathecal anaesthesia consisting of bupivacaine 15 mg placebo |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| atrial fibrillation | Cardiac disorders | Non-systematic Assessment | atrial fibrillation |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andreas Harsten | Region Skane | 46708870567 | andreas.harsten@skane.se |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D000077208 | Remifentanil |
| D000765 | Anesthesia, Conduction |
| ID | Term |
|---|---|
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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|
| RA-arm | Drug | Intrathecal (i.e. spinal) anesthesia with isobaric bupivacaine 15 mg administered intrathecally at L4-L5. |
|
|
| 9009936 | Background | Minto CF, Schnider TW, Shafer SL. Pharmacokinetics and pharmacodynamics of remifentanil. II. Model application. Anesthesiology. 1997 Jan;86(1):24-33. doi: 10.1097/00000542-199701000-00005. |
| 25736216 | Background | Harsten A, Kehlet H, Ljung P, Toksvig-Larsen S. Total intravenous general anaesthesia vs. spinal anaesthesia for total hip arthroplasty. Acta Anaesthesiol Scand. 2015 Apr;59(4):542-3. doi: 10.1111/aas.12495. Epub 2015 Mar 3. No abstract available. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex/Gender, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
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 |
|
|
| 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) | Two patients in the RA group were excluded because of the conversion to general anaesthesia. | Posted | Median | Inter-Quartile Range | score on a scale | from end of surgey until 48 hrs later |
|
|
|
| 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 | Two patients in the RA group were excluded because of the conversion to general anaesthesia. | Posted | Median | Inter-Quartile Range | hours | 12 hrs |
|
|
|
| 0 |
| 60 |
| 0 |
| 60 |
| 1 |
| 60 |
| EG001 | 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 | 0 | 60 | 0 | 60 | 1 | 60 |
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| D010468 |
| Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010880 |
| Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |