Injury of Anterior Cruciate LigamentNCT02589288
Adductor Canal Block: Continuous Infusion Versus Automatic Intermittent Bolus
A study testing Continuous Infusion of ropivacaine 0.2% and Automatic Intermittent Bolus of ropivacaine 0.2% in people with Injury of Anterior Cruciate Ligament, run by ASST Gaetano Pini-CTO at 1 site in Italy.
Trial summary
The aim of this prospective, randomized , blinded study is to compare two different infusion techniques (continuous VS intermittent automatic bolus) to assess the effects of postoperative analgesia after Day-Case anterior cruciate ligament (ACL) reconstruction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Injury of Anterior Cruciate Ligament
- What is being tested?
- Continuous Infusion of ropivacaine 0.2% and Automatic Intermittent Bolus of ropivacaine 0.2%
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2015to Mar 2017
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age above 18 years old
- American society of anesthesiology (ASA) physical status I-II
- Signed informed consensus
Who cannot join
- ASA >II
- Unstable neurological disease
- Diabetic mellitus (DM) type I-II
- Allergy to used drugs
- Opioid chronic treatment
- Consensus refusal or not valid
- Anticoagulant therapy
- Postoperative intensive care required
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adductor Canal Block: Continuous Infusion Versus Automatic Intermittent Bolus For Postoperative Analgesia After Day-Case Anterior Cruciate Ligament Reconstruction
The aim of this prospective, randomized , blinded study is to compare two different infusion techniques (continuous VS intermittent automatic bolus) to assess the effects of postoperative analgesia after Day-Case anterior cruciate ligament (ACL) reconstruction.
- Conditions
- Injury of Anterior Cruciate Ligament
- Being tested
- Continuous Infusion of ropivacaine 0.2%, Automatic Intermittent Bolus of ropivacaine 0.2%
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Infusion of ropivacaine 0.2%Procedure or surgery
Also called naropine 0.2%
Postoperative continuous infusion of Ropivacaine 0,2% at 6 ml/h and 4 ml PCA bolus, lockout 20 minutes via electronic infusion pump (Micrel device, Greece).
Automatic Intermittent Bolus of ropivacaine 0.2%Procedure or surgery
Postoperative Automatic Intermittent Bolus of 6 ml Ropivacaine 0,2% every hour and 4 ml PCA bolus, lockout 20 minutes via electronic infusion pump (Micrel device, Greece).
| Study group | Role | What they receive |
|---|---|---|
| Continuous Infusion | Active comparator | Patients receive a postoperative continuous infusion of Ropivacaine 0,2% at 6 ml/h and 4 ml PCA bolus, lockout 20 minutes via electronic infusion pump (Micrel device, Greece). Receives: Procedure: Continuous Infusion of ropivacaine 0.2% |
| Automatic Intermittent Bolus | Experimental | Patients receive a postoperative Automatic Intermittent Bolus of 6 ml Ropivacaine 0,2% and 4 ml PCA bolus, lockout 20 minutes every hour via electronic infusion pump (Micrel device, Greece). Receives: Procedure: Automatic Intermittent Bolus of ropivacaine 0.2% |
What is being measured
The primary outcome is the main question the study is designed to answer.
NRS Score
Evaluation of numeric rating score (NRS) in patient with automatic intermittent bolus of Ropivacaine 0,2% instead of classic continuous perfusion
Measured: 72h postoperative
Secondary outcomes (4)
Up and Go test
"up and go" test: time need to get up from a chair, walk for 3 meters, and come back to seat down on the chair
Measured: 72h postoperative
Opioids request
Opioids consumption will be recorded throughout 72 postoperative hours
Measured: 72h postoperative
Local anesthetic consumption
Evaluation of local anesthesia consumption every 6h in first 72 postoperative hours.
Measured: 72h postoperative
10mt walk test
time need to walk 10 meters
Measured: 72h postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2015 (estimated)
- Study startNov 2015
- Primary completionDec 2016
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Injury of Anterior Cruciate LigamentStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- ASST Gaetano Pini-CTO
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gianluca Cappelleri, ASST Gaetano Pini-CTO
- Investigators
- Gianluca Cappelleri, MD, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02589288
- Sponsor's protocol ID
- IOGPGC09
- Status last verified
- Aug 2017
- First submitted
- 27 Oct 2015
- Last updated
- 14 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adductor Canal Block: Continuous Infusion Versus Automatic Intermittent Bolus For Postoperative Analgesia After Day-Case Anterior Cruciate Ligament Reconstruction
- ClinicalTrials.gov ID
- NCT02589288
- Acronym / sponsor ID
- IOGPGC09
- Conditions
- Injury of Anterior Cruciate Ligament
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- ASST Gaetano Pini-CTOUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 28 Oct 2015 (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.
The aim of this prospective, randomized , blinded study is to compare two different infusion techniques (continuous VS intermittent automatic bolus) to assess the effects of postoperative analgesia after Day-Case anterior cruciate ligament (ACL) reconstruction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous Infusion | Active comparator | Procedure: Continuous Infusion of ropivacaine 0.2%Patients receive a postoperative continuous infusion of Ropivacaine 0,2% at 6 ml/h and 4 ml PCA bolus, lockout 20 minutes via electronic infusion pump (Micrel device, Greece). |
| Automatic Intermittent Bolus | Experimental | Procedure: Automatic Intermittent Bolus of ropivacaine 0.2%Patients receive a postoperative Automatic Intermittent Bolus of 6 ml Ropivacaine 0,2% and 4 ml PCA bolus, lockout 20 minutes every hour via electronic infusion pump (Micrel device, Greece). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age above 18 years old
- American society of anesthesiology (ASA) physical status I-II
- Signed informed consensus
Key exclusion criteria (8 listed)
- ASA >II
- Unstable neurological disease
- Diabetic mellitus (DM) type I-II
- Allergy to used drugs
- Opioid chronic treatment
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 |
|---|---|---|
| Continuous Infusion of ropivacaine 0.2%Also: naropine 0.2%Postoperative continuous infusion of Ropivacaine 0,2% at 6 ml/h and 4 ml PCA bolus, lockout 20 minutes via electronic infusion pump (Micrel device, Greece). | Procedure or surgery | Continuous Infusion |
| Automatic Intermittent Bolus of ropivacaine 0.2%Postoperative Automatic Intermittent Bolus of 6 ml Ropivacaine 0,2% every hour and 4 ml PCA bolus, lockout 20 minutes via electronic infusion pump (Micrel device, Greece). | Procedure or surgery | Automatic Intermittent Bolus |
Primary outcome
NRS Score
Time frame: 72h postoperative
Evaluation of numeric rating score (NRS) in patient with automatic intermittent bolus of Ropivacaine 0,2% instead of classic continuous perfusion
4 secondary outcomes
Up and Go test
Time frame: 72h postoperative
Opioids request
Time frame: 72h postoperative
Local anesthetic consumption
Time frame: 72h postoperative
10mt walk test
Time frame: 72h postoperative
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 14 Aug 2017.
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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.
Gianluca Cappelleri, MD principal investigator
Study Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Infusion of ropivacaine 0.2% and Automatic Intermittent Bolus of ropivacaine 0.2% in people with Injury of Anterior Cruciate Ligament, run by ASST Gaetano Pini-CTO at 1 site in Italy.
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 3 inclusion and 8 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 14 Aug 2017. 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 Italy. 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?
NRS Score (time frame: 72h postoperative). 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 14 Aug 2017.