- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05794282
Robotic Total Hip Arthroplasty Anesthesia Management
Robotic Total Hip Arthroplasty Anesthesia Management: Retrospective Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study was conducted after obtaining ethics committee approval.
The inclusion criteria were as follows: American Society of Anesthesiologists (ASA) physical status I-III patients between 40-85 years, elective unilateral THAs which were performed by a single senior orthopedic surgeon and orthopedic team between January 2021 and January 2023 under CSEA. Exclusion criteria were urgent surgery, bilateral surgery, previous surgery, missing data, and lost to follow-up in the perioperative period.
The routine anesthetic protocol for the TKA was as follows: A single dose of 0.5% hyperbaric bupivacaine between 15-10 mg was administered intratechally. Following this the epidural catheter was inserted 4 cm into the epidural space through the epidural needle and secured. The level of the sensory block was assessed using pin-prick and cold sensation tests, and motor block using the Bromage scale. The patients were followed in the postanesthesia care unit (PACU) after the surgery. Patients with a modified Aldrete scoring system ≥9 were considered to be eligible for the transfer from PACU to the service.
Pain was evaluated using a Visual Analogue Scale (VAS) with regular intervals. Data were collected from hospital's electronic database records, patient files, and anesthesia charts.
Study Type
Enrollment (Anticipated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- American Society of Anesthesiologists (ASA) physical status I-III
- Between 40-85 years
- Elective unilateral THAs which were performed by a single senior orthopedic surgeon
- Between January 2021 and January 2023 under CSEA.
Exclusion Criteria:
- Urgent surgery
- Bilateral surgery
- Previous surgery
- Missing data and lost to follow-up in the perioperative period
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Group rTHA (robotic total hip arthroplasty)
the robot assisted total hip arthroplasty
|
the robot assisted total hip arthroplasty
|
|
Group cTHA (conventional total hip arthroplasty)
the conventional total hip arthroplasty
|
the conventional total hip arthroplasty
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time
Time Frame: Only in surgery time, an average of 3 hours]
|
The duration of surgical procedures
|
Only in surgery time, an average of 3 hours]
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Complications
Time Frame: After the end of surgery, in the first 1-month follow-up
|
Perioperative complications rates
|
After the end of surgery, in the first 1-month follow-up
|
|
Hospital discharge time
Time Frame: Time from discharge from PACU to discharge from hospital, an average of 96 hours
|
Time from the beginning of the operation to the discharge of hospital
|
Time from discharge from PACU to discharge from hospital, an average of 96 hours
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-65
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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