Robotic Total Hip Arthroplasty Anesthesia Management

March 31, 2023 updated by: Umut Kara, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

Robotic Total Hip Arthroplasty Anesthesia Management: Retrospective Study

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.

Study Overview

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

Observational

Enrollment (Anticipated)

150

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with American Society of Anesthesiologists (ASA) physical status I-III and elective unilateral THAs between the ages of 40 and 85 will be analyzed.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2023

Primary Completion (Anticipated)

May 1, 2023

Study Completion (Anticipated)

May 15, 2023

Study Registration Dates

First Submitted

March 20, 2023

First Submitted That Met QC Criteria

March 20, 2023

First Posted (Actual)

April 3, 2023

Study Record Updates

Last Update Posted (Actual)

April 5, 2023

Last Update Submitted That Met QC Criteria

March 31, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 2023-65

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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