Rupture of Anterior Cruciate LigamentPhase 4NCT02524652
Local Infiltration Analgesia vs Adductor Canal Block for Analgesia After Anterior Cruciate Ligament Reconstruction
A Phase 4 study testing Ropivacaine 0.5% 20 mLs in people with Rupture of Anterior Cruciate Ligament and Infiltration, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
Trial summary
Early rehabilitation after anterior cruciate ligament reconstruction is of paramount importance and requires optimal pain control based on a multimodal concept, including injection of local anaesthetics. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Rupture of Anterior Cruciate Ligament, Infiltration, Regional Anesthesia Morbidity
- What is being tested?
- Ropivacaine 0.5% 20 mLs
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2015to Mar 2018
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients from 18 to 50 years old scheduled to undergo anterior cruciate ligament reconstruction
Who cannot join
- peripheral neuropathy
- pre-existing femoral neuropathy
- diabetes mellitus
- alcoholism
- drug addiction
- cancer with chemotherapy
- chronic pain state
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Anesthesia, Centre Hospitalier Universitaire Vaudois and University of Lausanne
Lausanne, Canton of Vaud, 1011
About this study
Official title: Postoperative Analgesic Efficacy of Local Infiltration Analgesia Versus Adductor Canal Block After Anterior Cruciate Ligament Reconstruction: A Randomised Controlled Double-blinded Trial
Early rehabilitation after anterior cruciate ligament reconstruction is of paramount importance and requires optimal pain control based on a multimodal concept, including injection of local anaesthetics. Regarding this latter, different options have emerged recently such as the adductor canal block, performed before the surgery by the anaesthesiologist or the infiltration of the articulation performed by the surgeon at the of the intervention. No trial has compared these two approaches. As practice of medicine should be based on evidence, we decided to undertake this randomised controlled trial where we compared the adductor canal block with the local infiltration analgesia technique in terms of pain and functional outcomes
Read the detailed description
Patients scheduled to undergo anterior cruciate ligament reconstruction under general anaesthesia will be randomly allocated to two groups: local infiltration analgesia or adductor canal block.
The local infiltration analgesia will be performed by the surgeon at the end of surgery with 20 mLs of ropivacaine 0.5%. The adductor canal block will be performed by the anaesthesiologist under ultrasound guidance after the surgery, before awaking the patient, using the same solution (20 mLs ropivacaine 0.5%)
Postoperative analgesia will include intravenous patient-controlled analgesia of morphine (settings 1 mg/ml, 2 ml/10 minutes, 40 mg/4 hours), ibuprofen (3x400 mg) and acetaminophen (4x1000 mg).
A research assistant and a physiotherapist, both blinded to the group allocation, will collect pain and rehabilitation data, respectively.
- Being tested
- Ropivacaine 0.5% 20 mLs
- 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.
Ropivacaine 0.5% 20 mLsDrug
Also called Naropine, Naropin
Injection of the local anesthetic at the end of surgery, either in the surgical sites by the surgeon, or in the adductor canal block by the anesthesiologist under ultrasound guidance.
| Study group | Role | What they receive |
|---|---|---|
| Local infiltration analgesia | Experimental | Infiltration of the knee by the surgeon with local anaesthetics under general anaesthesia. Receives: Drug: Ropivacaine 0.5% 20 mLs |
| Adductor canal block | Active comparator | Injection of local anaesthetics under ultrasound guidance in the adductor canal by the anaesthesiologist after the surgery, before awaking the patient. Receives: Drug: Ropivacaine 0.5% 20 mLs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total morphine consumption (mg)
Measured: 24 h postoperatively
Secondary outcomes (29)
Total morphine consumption (mg)
Measured: 2 h postoperatively
Total morphine consumption (mg)
Measured: 48 h postoperatively
Total morphine consumption (mg)
Measured: 72 h postoperatively
Pain scores (numeric rating scale, 0-10) at rest and on movement
Measured: 2 h postoperatively
Pain scores (numeric rating scale, 0-10) at rest and on movement
Measured: 12 h postoperatively
Pain scores (numeric rating scale, 0-10) at rest and on movement
Measured: 24 h postoperatively
Pain scores (numeric rating scale, 0-10) at rest and on movement
Measured: 36 h postoperatively
Pain scores (numeric rating scale, 0-10) at rest and on movement
Measured: 48 h postoperatively
Pain scores (numeric rating scale, 0-10) at rest and on movement
Measured: 60 h postoperatively
Pain scores (numeric rating scale, 0-10) at rest and on movement
Measured: 72 h postoperatively
Postoperative nausea and vomiting (yes/no)
Measured: 24 h postoperatively
Postoperative nausea and vomiting (yes/no)
Measured: 48 h postoperatively
Postoperative nausea and vomiting (yes/no)
Measured: 72 h postoperatively
Pruritus (yes/no)
Measured: 24 h postoperatively
Pruritus (yes/no)
Measured: 48 h postoperatively
Pruritus (yes/no)
Measured: 72 h postoperatively
Active flexion
Flexion of the knee by the patient measured in degrees
Measured: 24 h postoperatively
Active flexion
Flexion of the knee by the patient measured in degrees
Measured: 48 h postoperatively
Active flexion
Flexion of the knee by the patient measured in degrees
Measured: 72 h postoperatively
Quadriceps muscle strength (numeric scale, 1-5)
Measured: 24 h postoperatively
Quadriceps muscle strength (numeric scale, 1-5)
Measured: 48 h postoperatively
Quadriceps muscle strength (numeric scale, 1-5)
Measured: 72 h postoperatively
Distance walked (meters)
Measured: 24 h postoperatively
Distance walked (meters)
Measured: 48 h postoperatively
Distance walked (meters)
Measured: 72 h postoperatively
Anterior Cruciate Ligament - Return to Sport after Injury scale
Measured: 4 months postoperatively
Anterior cruciate ligament -Return to Sport after Injury scale
Measured: 8 months postoperatively
International Knee Documentation Committee score
Measured: 4 months postoperatively
International Knee Documentation Committee score
Measured: 8 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2015 (estimated)
- Study startSep 2015
- Primary completionMar 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rupture of Anterior Cruciate LigamentStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire VaudoisThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Albrecht, Centre Hospitalier Universitaire Vaudois
- Investigators
- Eric Albrecht, PD Dr, Principal investigator, CHUV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02524652
- Sponsor's protocol ID
- CER 193-15
- Status last verified
- May 2018
- First submitted
- 6 Aug 2015
- Last updated
- 7 May 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Stebler K, Martin R, Kirkham KR, Lambert J, De Sede A, Albrecht E. Adductor canal block versus local infiltration analgesia for postoperative pain after anterior cruciate ligament reconstruction: a single centre randomised controlled triple-blinded trial. Br J Anaesth. 2019 Aug;123(2):e343-e349. doi: 10.1016/j.bja.2019.04.053. Epub 2019 May 24.
PubMed 31130273
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Analgesic Efficacy of Local Infiltration Analgesia Versus Adductor Canal Block After Anterior Cruciate Ligament Reconstruction: A Randomised Controlled Double-blinded Trial
- ClinicalTrials.gov ID
- NCT02524652
- Acronym / sponsor ID
- CER 193-15
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 17 Aug 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.
Early rehabilitation after anterior cruciate ligament reconstruction is of paramount importance and requires optimal pain control based on a multimodal concept, including injection of local anaesthetics. Regarding this latter, different options have emerged recently such as the adductor canal block, performed before the surgery by the anaesthesiologist or the infiltration of the articulation performed by the surgeon at the of the intervention. No trial has compared these two approaches. As practice of medicine should be based on evidence, we decided to undertake this randomised controlled trial where we compared the adductor canal block with the local infiltration analgesia technique in terms of pain and functional outcomes
Detailed description
Patients scheduled to undergo anterior cruciate ligament reconstruction under general anaesthesia will be randomly allocated to two groups: local infiltration analgesia or adductor canal block.
The local infiltration analgesia will be performed by the surgeon at the end of surgery with 20 mLs of ropivacaine 0.5%. The adductor canal block will be performed by the anaesthesiologist under ultrasound guidance after the surgery, before awaking the patient, using the same solution (20 mLs ropivacaine 0.5%)
Postoperative analgesia will include intravenous patient-controlled analgesia of morphine (settings 1 mg/ml, 2 ml/10 minutes, 40 mg/4 hours), ibuprofen (3x400 mg) and acetaminophen (4x1000 mg).
A research assistant and a physiotherapist, both blinded to the group allocation, will collect pain and rehabilitation data, respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Local infiltration analgesia | Experimental | Drug: Ropivacaine 0.5% 20 mLsInfiltration of the knee by the surgeon with local anaesthetics under general anaesthesia. |
| Adductor canal block | Active comparator | Drug: Ropivacaine 0.5% 20 mLsInjection of local anaesthetics under ultrasound guidance in the adductor canal by the anaesthesiologist after the surgery, before awaking the patient. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patients from 18 to 50 years old scheduled to undergo anterior cruciate ligament reconstruction
Key exclusion criteria (7 listed)
- peripheral neuropathy
- pre-existing femoral neuropathy
- diabetes mellitus
- alcoholism
- drug addiction
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 |
|---|---|---|
| Ropivacaine 0.5% 20 mLsAlso: Naropine, NaropinInjection of the local anesthetic at the end of surgery, either in the surgical sites by the surgeon, or in the adductor canal block by the anesthesiologist under ultrasound guidance. | Drug | Adductor canal block, Local infiltration analgesia |
Primary outcome
Total morphine consumption (mg)
Time frame: 24 h postoperatively
29 secondary outcomes
Total morphine consumption (mg)
Time frame: 2 h postoperatively
Total morphine consumption (mg)
Time frame: 48 h postoperatively
Total morphine consumption (mg)
Time frame: 72 h postoperatively
Pain scores (numeric rating scale, 0-10) at rest and on movement
Time frame: 2 h postoperatively
Pain scores (numeric rating scale, 0-10) at rest and on movement
Time frame: 12 h postoperatively
Pain scores (numeric rating scale, 0-10) at rest and on movement
Time frame: 24 h postoperatively
Pain scores (numeric rating scale, 0-10) at rest and on movement
Time frame: 36 h postoperatively
Pain scores (numeric rating scale, 0-10) at rest and on movement
Time frame: 48 h postoperatively
Pain scores (numeric rating scale, 0-10) at rest and on movement
Time frame: 60 h postoperatively
Pain scores (numeric rating scale, 0-10) at rest and on movement
Time frame: 72 h postoperatively
Postoperative nausea and vomiting (yes/no)
Time frame: 24 h postoperatively
Postoperative nausea and vomiting (yes/no)
Time frame: 48 h postoperatively
Postoperative nausea and vomiting (yes/no)
Time frame: 72 h postoperatively
Pruritus (yes/no)
Time frame: 24 h postoperatively
Pruritus (yes/no)
Time frame: 48 h postoperatively
Pruritus (yes/no)
Time frame: 72 h postoperatively
Active flexion
Time frame: 24 h postoperatively
Active flexion
Time frame: 48 h postoperatively
Active flexion
Time frame: 72 h postoperatively
Quadriceps muscle strength (numeric scale, 1-5)
Time frame: 24 h postoperatively
Quadriceps muscle strength (numeric scale, 1-5)
Time frame: 48 h postoperatively
Quadriceps muscle strength (numeric scale, 1-5)
Time frame: 72 h postoperatively
Distance walked (meters)
Time frame: 24 h postoperatively
Distance walked (meters)
Time frame: 48 h postoperatively
Distance walked (meters)
Time frame: 72 h postoperatively
Anterior Cruciate Ligament - Return to Sport after Injury scale
Time frame: 4 months postoperatively
Anterior cruciate ligament -Return to Sport after Injury scale
Time frame: 8 months postoperatively
International Knee Documentation Committee score
Time frame: 4 months postoperatively
International Knee Documentation Committee score
Time frame: 8 months postoperatively
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 7 May 2018.
- Derived from this study: PubMed 31130273Stebler K, Martin R, Kirkham KR, Lambert J, De Sede A, Albrecht E. Adductor canal block versus local infiltration analgesia for postoperative pain after anterior cruciate ligament reconstruction: a single centre randomised controlled triple-blinded trial. Br J Anaesth. 2019 Aug;123(2):e343-e349. doi: 10.1016/j.bja.2019.04.053. Epub 2019 May 24.
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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.
Eric Albrecht, PD Dr principal investigator
CHUV
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ropivacaine 0.5% 20 mLs in people with Rupture of Anterior Cruciate Ligament and Infiltration, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
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 1 inclusion and 7 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 7 May 2018. 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 Switzerland. 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?
Total morphine consumption (mg) (time frame: 24 h postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02524652, which also lists 1 linked publication.
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 7 May 2018.