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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05794282
Other study ID # 2023-65
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 1, 2023
Est. completion date May 15, 2023

Study information

Verified date March 2023
Source Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
Contact Umut Kara
Phone +905339392399
Email drumutkara@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Robotic arthroplasty is increasing in acceptance on a global scale as a result of advancements in orthopedic surgery technology. The investigators aimed to share their anesthesia management experience as well as compare robotic unilateral total hip arthroplasty with conventional surgical technique in this retrospective study.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 150
Est. completion date May 15, 2023
Est. primary completion date May 1, 2023
Accepts healthy volunteers No
Gender All
Age group 40 Years to 85 Years
Eligibility 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 Design


Intervention

Procedure:
the robot assisted total hip arthroplasty
the robot assisted total hip arthroplasty
the conventional total hip arthroplasty
the conventional total hip arthroplasty

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

Outcome

Type Measure Description Time frame Safety issue
Primary Time The duration of surgical procedures Only in surgery time, an average of 3 hours]
Secondary Complications Perioperative complications rates After the end of surgery, in the first 1-month follow-up
Secondary Hospital discharge time 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
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