Knee ArthroscopyPhase 4NCT03038958
Comparison of Hyperbaric Prilocaine With Chloroprocaine for Intrathecal Anaesthesia in Day Case Knee Arthroscopy
A Phase 4 study testing Isobaric 2-chloroprocaine and Hyperbaric prilocaine in people with Knee Arthroscopy and Spinal Anesthesia, run by Centre Hospitalier Universitaire Saint Pierre at 2 sites in Belgium.
Trial summary
This study compares intrathecal 1% plain chloroprocaine with intrathecal 2% hyperbaric prilocaine for patients undergoing ambulatory knee arthroscopy in terms of efficacy and side effects Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Knee Arthroscopy, Spinal Anesthesia
- What is being tested?
- Isobaric 2-chloroprocaine and Hyperbaric prilocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesBelgium
- Study dates
- Apr 2016to Jul 2016
- Phase
- Phase 4
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiology physical status (ASA) ≤ III
- Age 18-80 year
- Height between 160 and 185 cm
- Signed informed consent obtained prior to any study specific assessments and procedures
Who cannot join
- Cardiac pathology (such as Heart failure, Aortic stenosis)
- Coagulation disorders (INR>1.3, platelet < 80 000/mm3)
- Known allergy to local anaesthetics
- Disagreement of the patient
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
Braine-l'Alleud Hospital
Braine-l'Alleud, 1420
CHU Saint-Pierre
Brussels Capital Region, 1000
About this study
This study compares intrathecal 1% plain chloroprocaine with intrathecal 2% hyperbaric prilocaine for patients undergoing ambulatory knee arthroscopy in terms of efficacy and side effects
- Conditions
- Knee Arthroscopy, Spinal Anesthesia
- Being tested
- Isobaric 2-chloroprocaine, Hyperbaric prilocaine
- Keywords
- Local Anaesthetic, spinal anesthesia, Knee arthroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isobaric 2-chloroprocaineDrug
Also called Ampres
intrathecal injection of 50 mg isobaric 2-Chloroprocaine
Hyperbaric prilocaineDrug
Also called Tachipri
intrathecal injection of 50 mg hyperbaric prilocaine 2%
| Study group | Role | What they receive |
|---|---|---|
| Isobaric 2-chloroprocaine | Active comparator | The 50 mg dose of isobaric 2-chloroprocaine will be administered to patients undergoing ambulatory knee arthroscopy Receives: Drug: Isobaric 2-chloroprocaine |
| Hyperbaric prilocaine 2% | Active comparator | The dose of 50 mg of Hyperbaric prilocaine 2% will be administered to patients undergoing ambulatory knee arthroscopy Receives: Drug: Hyperbaric prilocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of sensory block
Total duration of sensory block is the interval time between the end of intrathecal injection and the complete recovery of sensory block
Measured: Until complete release of sensory block
Secondary outcomes (5)
Onset time of sensory block
The levels of sensory block will be determined at 5, 10, 20 and 30 minutes after intrathecal injection. The levels of sensory block will be assessed as loss of sensation to pin-prick and cold.
Measured: up to 30 minutes
Onset time of motor block
The levels of motor block will be determined at 5, 10, 20 and 30 minutes after intrathecal injection. The levels of motor block will be assessed by using the Bromage Scale (0=no motor block; 1=hip blocked; 2=hip and knee blocked; 3=hip, knee, and ankle blocked).
Measured: up to 30 minutes
Duration of motor block
Total duration of motor block is the interval time between the end of intrathecal injection and the complete recovery of motor block
Measured: Until complete regression of motor block
Pain assessed by Visual Analog Scale
Pain levels will be determined at the inflation of tourniquet, at the incision and every 10 minutes in the PACU (Post Anesthesia Care Unit). Visual Analog pain score (scale = 0 no pain; 10 = worst pain imaginable).
Measured: up to 24 hours
Side-effects (hypotension, bradycardia, urinary retention)
Assessed during and after intervention
Measured: up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2017 (estimated)
- Study startApr 2016
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee ArthroscopyStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Saint Pierre
- Sponsor type
- University, hospital or other
- Collaborators
- Hôpital de Braine-l'Alleud
- Responsible party
- Sponsor
- Investigators
- Emmanuel Guntz, MD, Study director, Université Libre de Bruxelles (ULB), Braine-l'Alleud HospitalPanayota Kapessidou, MD,PhD, Principal investigator, University Hospital Saint-Pierre (CHU Saint-Pierre), Université Libre de Bruxelles (ULB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03038958
- Sponsor's protocol ID
- AK160324627AD
- Status last verified
- Nov 2019
- First submitted
- 26 Jan 2017
- Last updated
- 18 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Hyperbaric Prilocaine With Chloroprocaine for Intrathecal Anaesthesia in Day Case Knee Arthroscopy
- ClinicalTrials.gov ID
- NCT03038958
- Acronym / sponsor ID
- AK160324627AD
- Conditions
- Knee Arthroscopy, Spinal Anesthesia
- Keywords
- Local Anaesthetic, spinal anesthesia, Knee arthroscopy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire Saint PierreUniversity, hospital or other
- Collaborators
- Hôpital de Braine-l'Alleud
- Study start
- Apr 2016
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 1 Feb 2017 (estimated)
- 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 compares intrathecal 1% plain chloroprocaine with intrathecal 2% hyperbaric prilocaine for patients undergoing ambulatory knee arthroscopy in terms of efficacy and side effects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Isobaric 2-chloroprocaine | Active comparator | Drug: Isobaric 2-chloroprocaineThe 50 mg dose of isobaric 2-chloroprocaine will be administered to patients undergoing ambulatory knee arthroscopy |
| Hyperbaric prilocaine 2% | Active comparator | Drug: Hyperbaric prilocaineThe dose of 50 mg of Hyperbaric prilocaine 2% will be administered to patients undergoing ambulatory knee arthroscopy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- American Society of Anesthesiology physical status (ASA) ≤ III
- Age 18-80 year
- Height between 160 and 185 cm
- Signed informed consent obtained prior to any study specific assessments and procedures
Key exclusion criteria (4 listed)
- Cardiac pathology (such as Heart failure, Aortic stenosis)
- Coagulation disorders (INR>1.3, platelet < 80 000/mm3)
- Known allergy to local anaesthetics
- Disagreement of the patient
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 |
|---|---|---|
| Isobaric 2-chloroprocaineAlso: Ampresintrathecal injection of 50 mg isobaric 2-Chloroprocaine | Drug | Isobaric 2-chloroprocaine |
| Hyperbaric prilocaineAlso: Tachipriintrathecal injection of 50 mg hyperbaric prilocaine 2% | Drug | Hyperbaric prilocaine 2% |
Primary outcome
Duration of sensory block
Time frame: Until complete release of sensory block
Total duration of sensory block is the interval time between the end of intrathecal injection and the complete recovery of sensory block
5 secondary outcomes
Onset time of sensory block
Time frame: up to 30 minutes
Onset time of motor block
Time frame: up to 30 minutes
Duration of motor block
Time frame: Until complete regression of motor block
Pain assessed by Visual Analog Scale
Time frame: up to 24 hours
Side-effects (hypotension, bradycardia, urinary retention)
Time frame: up to 24 hours
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 18 Nov 2019.
- Individual participant dataSharing planned: No
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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.
Emmanuel Guntz, MD study director
Université Libre de Bruxelles (ULB), Braine-l'Alleud Hospital
Panayota Kapessidou, MD,PhD principal investigator
University Hospital Saint-Pierre (CHU Saint-Pierre), Université Libre de Bruxelles (ULB)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Isobaric 2-chloroprocaine and Hyperbaric prilocaine in people with Knee Arthroscopy and Spinal Anesthesia, run by Centre Hospitalier Universitaire Saint Pierre at 2 sites in Belgium.
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 4 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 18 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Duration of sensory block (time frame: Until complete release of sensory block). 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 18 Nov 2019; AzTrials last refreshed its copy on 8 Nov 2026.