Lower Limb Arthroplasty Under Chloroprocaine Spinal AnesthesiaNCT05365074
Intrathecal Chloroprocaine for Lower Limb Arthroplasty
An observational study of Lower Limb Arthroplasty Under Chloroprocaine Spinal Anesthesia, run by Hôpital de la Croix-Rousse at 1 site in France.
Trial summary
This study evaluates the perioperative course in adult patients undergoing total or partial knee arthroplasty, or total hip arthroplasty under chloroprocaine spinal anesthesia. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lower Limb Arthroplasty Under Chloroprocaine Spinal Anesthesia
- What is being tested?
- Chloroprocaine Injection
- Type of treatment
- Injection or infusion
- How many people
- 65 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2020to 2 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Child, Adult, Older adult
Study population: Adult patients operated for total knee, unicompartment knee or anterior access hip arthroplasty under chloroprocaine spinal anesthesia in the period of years 2020 - 2021
Who may be able to join
- 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
Who cannot join
- expressed disagreement to to participate after receiving information notice
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Perioperative Outcomes in Patients Received Spinal Chloroprocaine for Hip or Knee Arthroplasty
This study evaluates the perioperative course in adult patients undergoing total or partial knee arthroplasty, or total hip arthroplasty under chloroprocaine spinal anesthesia.
Read the 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.
- Being tested
- Chloroprocaine Injection
- Keywords
- chloroprocaine, total hip arthroplasty, total knee arthroplasty, unicompartmental knee arthroplasty, spinal anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chloroprocaine InjectionDrug
Spinal anesthesia with 50 mg of 1% Chloroprocaine
| Study group | Role | What they receive |
|---|---|---|
| chloroprocaine anesthesia for arthroplasty | 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 Receives: Drug: Chloroprocaine Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spinal anesthesia failure
proportion of patients with the necessity to convert initially planned spinal anesthesia into general anesthesia
Measured: Day 0
Secondary outcomes (7)
Hemodynamic instability
proportion of patients with >20% changes in blood pressure and ou heart rate comparing to baseline
Measured: Day 0
Need for sedation
proportion of patients requiring intraoperative sedation for uncomfortable conditions
Measured: Day 0
Surgical block duration
time of regression of sensitive and motor spinal block
Measured: Day 0
PACU analgesia requirement
morphine equivalent requirement in PACU for the postoperative pain
Measured: Day 0
Urinary retention
proportion of patients requiring urinary catheter
Measured: 24 hours
Postoperative nausea and vomiting
proportion of patients having nausea and vomiting
Measured: 24 hours
Length of stay in recovery room
Length of stay in recovery room
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2022
- Study start1 Jan 2020
- Primary completion31 Dec 2021
- Study completion2 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Limb Arthroplasty Under Chloroprocaine Spinal AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital de la Croix-Rousse
- Sponsor type
- University, hospital or other
- Collaborators
- Hospices Civils de Lyon
- Responsible party
- Principal investigator, Mikhail Dziadzko, MD, PhD, Hôpital de la Croix-Rousse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05365074
- Sponsor's protocol ID
- CSE-HCL 22_729
- Status last verified
- May 2022
- First submitted
- 18 Apr 2022
- Last updated
- 9 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD are protected by the French regulation and will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Outcomes in Patients Received Spinal Chloroprocaine for Hip or Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT05365074
- Acronym / sponsor ID
- CSE-HCL 22_729
- Keywords
- chloroprocaine, total hip arthroplasty, total knee arthroplasty, unicompartmental knee arthroplasty, spinal anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Hôpital de la Croix-RousseUniversity, hospital or other
- Collaborators
- Hospices Civils de Lyon
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 2 Mar 2022 (actual)
- First posted
- 9 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| chloroprocaine anesthesia for arthroplasty | – | Drug: Chloroprocaine Injectionpatients 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 |
Who may qualify
- Age groups
- Child, Adult, Older adult
- Study population
- Adult patients operated for total knee, unicompartment knee or anterior access hip arthroplasty under chloroprocaine spinal anesthesia in the period of years 2020 - 2021
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- expressed disagreement to to participate after receiving information notice
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chloroprocaine InjectionSpinal anesthesia with 50 mg of 1% Chloroprocaine | Drug | chloroprocaine anesthesia for arthroplasty |
Primary outcome
Spinal anesthesia failure
Time frame: Day 0
proportion of patients with the necessity to convert initially planned spinal anesthesia into general anesthesia
7 secondary outcomes
Hemodynamic instability
Time frame: Day 0
Need for sedation
Time frame: Day 0
Surgical block duration
Time frame: Day 0
PACU analgesia requirement
Time frame: Day 0
Urinary retention
Time frame: 24 hours
Postoperative nausea and vomiting
Time frame: 24 hours
Length of stay in recovery room
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2022.
- Individual participant dataSharing planned: No. IPD are protected by the French regulation and will not be shared
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lower Limb Arthroplasty Under Chloroprocaine Spinal Anesthesia, run by Hôpital de la Croix-Rousse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spinal anesthesia failure (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2022.