Intrathecal Chloroprocaine for Lower Limb Arthroplasty

Completed

• Conditions: Lower Limb Arthroplasty Under Chloroprocaine Spinal Anesthesia
• Interventions: Drug: Chloroprocaine Injection

• Registration Number: NCT05365074
• Lead Sponsor: Hôpital de la Croix-Rousse

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2020-01-01
• Primary Completion: 2021-12-31
• Study Completion: 2022-03-02
• Study First Submitted: 2022-04-18
• Status Verified: 2022-05
• Study First Submitted QC: 2022-05-03
• Last Update Submitted: 2022-05-03
• Study First Posted: 2022-05-09
• Last Update Posted: 2022-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Not specified
• Target Recruitment: 65

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
chloroprocaine anesthesia for arthroplasty	Chloroprocaine Injection	patients having predicted uncomplicated surgery for total or unicompartment knee arthroplasty of anterior access total hip arthroplasty, operated under spinal anesthesia with 50 mg of chloroprocaine

Primary Outcome Measures

Name	Time	Method
Spinal anesthesia failure	Day 0	proportion of patients with the necessity to convert initially planned spinal anesthesia into general anesthesia

Secondary Outcome Measures

Name	Time	Method
Urinary retention	24 hours	proportion of patients requiring urinary catheter
Postoperative nausea and vomiting	24 hours	proportion of patients having nausea and vomiting
PACU analgesia requirement	Day 0	morphine equivalent requirement in PACU for the postoperative pain
Need for sedation	Day 0	proportion of patients requiring intraoperative sedation for uncomfortable conditions
Surgical block duration	Day 0	time of regression of sensitive and motor spinal block
Hemodynamic instability	Day 0	proportion of patients with \>20% changes in blood pressure and ou heart rate comparing to baseline
Length of stay in recovery room	Day 0	Length of stay in recovery room

Trial Locations

Locations (1)

Hopital de la Croix Rousse - Hospices Civils de Lyon; 🇫🇷 Lyon, France