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Completed

NCT Number: NCT05365074

Intrathecal Chloroprocaine for Lower Limb Arthroplasty

This study evaluates the perioperative course in adult patients undergoing total or partial knee arthroplasty, or total hip arthroplasty under chloroprocaine spinal anesthesia.

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Key information

Conditions

Lower Limb Arthroplasty Under Chloroprocaine Spinal Anesthesia

Study type

Observational

Primary location

Hopital de la Croix Rousse - Hospices Civils de Lyon

Lyon, 69004, France

About this study

This study evaluates the failure rate of spinal anesthesia, the duration of surgical anesthesia, the needs for complementary intraoperative analgesia, the time for recovery, the incidence of urinary retention, postoperative nausea and vomiting, and length of stay in the recovery room in patients operated for knee or hip arthroplasty under spinal anesthesia with chloroprocaine 50 mg.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adult patients
  • with spinal anesthesia using 50 mg of chloroprocaine
  • operated for total knee, unicompartment knee or anterior access hip arthroplasty
  • in the period of years 2020 - 2021

Exclusion criteria

  • expressed disagreement to to participate after receiving information notice

Treatment and study plan

Chloroprocaine Injection

Drug

Spinal anesthesia with 50 mg of 1% Chloroprocaine

Primary outcomes

  1. Spinal anesthesia failure

    Time frame: Day 0

    proportion of patients with the necessity to convert initially planned spinal anesthesia into general anesthesia

Secondary outcomes

  1. Hemodynamic instability

    Time frame: Day 0

    proportion of patients with >20% changes in blood pressure and ou heart rate comparing to baseline

  2. Need for sedation

    Time frame: Day 0

    proportion of patients requiring intraoperative sedation for uncomfortable conditions

  3. Surgical block duration

    Time frame: Day 0

    time of regression of sensitive and motor spinal block

  4. PACU analgesia requirement

    Time frame: Day 0

    morphine equivalent requirement in PACU for the postoperative pain

  5. Urinary retention

    Time frame: 24 hours

    proportion of patients requiring urinary catheter

  6. Postoperative nausea and vomiting

    Time frame: 24 hours

    proportion of patients having nausea and vomiting

  7. Length of stay in recovery room

    Time frame: Day 0

    Length of stay in recovery room

Sponsors and collaborators

Lead sponsor

Hôpital de la Croix-Rousse

Other

Collaborators

  • Hospices Civils de Lyon

Registry information

Official study title

Perioperative Outcomes in Patients Received Spinal Chloroprocaine for Hip or Knee Arthroplasty

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
May 9, 2022
Registry last updated
May 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.