Robotic Total Hip Arthroplasty Anesthesia Management

Sponsor
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05794282
Collaborator
(none)
150
1.4

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: the robot assisted total hip arthroplasty
  • Procedure: the conventional total hip arthroplasty

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 Design

Study Type:
Observational
Anticipated Enrollment :
150 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Robotic Total Hip Arthroplasty Anesthesia Management: Retrospective Study
Anticipated Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
May 15, 2023

Arms and Interventions

Arm Intervention/Treatment
Group rTHA (robotic total hip arthroplasty)

the robot assisted total hip arthroplasty

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

Group cTHA (conventional total hip arthroplasty)

the conventional total hip arthroplasty

Procedure: the conventional total hip arthroplasty
the conventional total hip arthroplasty

Outcome Measures

Primary Outcome Measures

  1. Time [Only in surgery time, an average of 3 hours]]

    The duration of surgical procedures

Secondary Outcome Measures

  1. Complications [After the end of surgery, in the first 1-month follow-up]

    Perioperative complications rates

  2. Hospital discharge time [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Umut Kara, Associate Professor, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
ClinicalTrials.gov Identifier:
NCT05794282
Other Study ID Numbers:
  • 2023-65
First Posted:
Apr 3, 2023
Last Update Posted:
Apr 5, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 5, 2023