Postoperative PainNCT03680716
Combined Saphenous Nerve and IPACK Blocks Versus Infiltration Analgesia After Anterior Cruciate Ligament Reconstruction
A study testing Ropivacaine injection in people with Postoperative Pain and Anterior Cruciate Ligament Injury, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
Trial summary
A lot of patient have posterior knee pain after ACL reconstruction despite saphenous nerve block. Recently a new block has been described, know as IPACK block (interspace between the popliteal artery and the capsule of the posterior knee). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain, Anterior Cruciate Ligament Injury, Anterior Cruciate Ligament Rupture
- What is being tested?
- Ropivacaine injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Nov 2018to 1 Oct 2020
- 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
- Statut ASA I-III.
- Patient scheduled for anterior crutiate ligament reconstruction under general anesthesia.
Who cannot join
- Pregnancy.
- Contraindication to local anesthesia.
- Patient with chronic pain, opioid consumption or alcohol consumption.
- Patient with coagulation trouble, hepatic dysfunction or renal dysfunction.
- Patient with diabetic or femoral neuropathy.
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: Analgesic Efficacy of a Combined Saphenous Nerve Block and IPACK Block Versus Local Infiltration Analgesia After Anterior Cruciate Ligament Reconstruction: a Randomized Controlled Double-blinded Trial.
A lot of patient have posterior knee pain after ACL reconstruction despite saphenous nerve block. Recently a new block has been described, know as IPACK block (interspace between the popliteal artery and the capsule of the posterior knee). The objective of this randomized controlled double-blinded trial is to assess whether a combined saphenous nerve block with IPACK block is more effective for the postoperative pain than a local infiltration analgesia.
Read the detailed description
The saphenous nerve and the iPACK will be performed after general anaesthesia induction and before the surgery under ultrasound-guidance.
The local infiltration analgesia will be performed by the surgeon during the surgery.
- Being tested
- Ropivacaine injection
- Medical subject headings
- Pain, Postoperative, Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine injectionDrug
Saphenous nerve block with 20ml of ropivacaine 0.5% and IPACK block with 30ml of ropivacaine 0.2% (total dose of 160 mg).
Ropivacaine injectionDrug
Periarticular infiltration of 80 ml ropivacaine 0.2% (total dose of 160mg).
| Study group | Role | What they receive |
|---|---|---|
| IPACK block | Experimental | Saphenous nerve block and IPACK block by anesthetist under ultrasound guidance. Receives: Drug: Ropivacaine injection |
| Local infiltration analgesia | Active comparator | Periarticular infiltration by surgeon Receives: Drug: Ropivacaine injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total morphine consumption (mg)
Measured: 24 hours postoperatively
Secondary outcomes (10)
Total morphine consumption (mg)
Measured: 2 hours, 48 hours and 72 hours postoperatively
Pain scores (numeric rating scale, 0-10) at rest and on movement
0= no pain, 10=the worst pain imaginable
Measured: 2hours, 24hours, 48hours and 72hours postoperatively
Rate of postoperative nausea and vomiting
Yes/No
Measured: 2hours, 24hours, 48hours and 72hours postoperatively
Rate of antiemetic consumption
Yes/No
Measured: 2hours, 24hours, 48hours and 72hours postoperatively
Rate of pruritus
Yes/No
Measured: 2hours, 24hours, 48hours and 72hours postoperatively
Active flexion
Flexion of the knee by the patient measured in degrees
Measured: 24hours, 48hours and 72hours postoperatively
Quadriceps muscle strength (numeric scale, 1-5)
1=no contraction, 5=normal strength
Measured: 24hours, 48hours and 72hours postoperatively
Distance walked (meters)
Measured: 24 hours, 48hours and 72hours postoperatively
Anterior Cruciate Ligament - Return to Sport after Injury survey
Measured: 4 and 8 postoperative months
International Knee Documentation Committee score
Measured: 4 and 8 postoperative months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2018
- Study start1 Nov 2018
- Primary completion1 Oct 2020
- Study completion1 Oct 2020
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 Postoperative PainStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03680716
- Sponsor's protocol ID
- CER 2018-01163
- Status last verified
- Jan 2021
- First submitted
- 20 Sep 2018
- Last updated
- 27 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Martin R, Kirkham KR, Ngo THN, Gonvers E, Lambert J, Albrecht E. Combination of femoral triangle block and infiltration between the popliteal artery and the capsule of the posterior knee (iPACK) versus local infiltration analgesia for analgesia after anterior cruciate ligament reconstruction: a randomized controlled triple-blinded trial. Reg Anesth Pain Med. 2021 Sep;46(9):763-768. doi: 10.1136/rapm-2021-102631. Epub 2021 May 26.
PubMed 34039734
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of a Combined Saphenous Nerve Block and IPACK Block Versus Local Infiltration Analgesia After Anterior Cruciate Ligament Reconstruction: a Randomized Controlled Double-blinded Trial.
- ClinicalTrials.gov ID
- NCT03680716
- Acronym / sponsor ID
- CER 2018-01163
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 21 Sep 2018 (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.
A lot of patient have posterior knee pain after ACL reconstruction despite saphenous nerve block. Recently a new block has been described, know as IPACK block (interspace between the popliteal artery and the capsule of the posterior knee). The objective of this randomized controlled double-blinded trial is to assess whether a combined saphenous nerve block with IPACK block is more effective for the postoperative pain than a local infiltration analgesia.
Detailed description
The saphenous nerve and the iPACK will be performed after general anaesthesia induction and before the surgery under ultrasound-guidance.
The local infiltration analgesia will be performed by the surgeon during the surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IPACK block | Experimental | Drug: Ropivacaine injectionSaphenous nerve block and IPACK block by anesthetist under ultrasound guidance. |
| Local infiltration analgesia | Active comparator | Drug: Ropivacaine injectionPeriarticular infiltration by surgeon |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Statut ASA I-III.
- Patient scheduled for anterior crutiate ligament reconstruction under general anesthesia.
Key exclusion criteria (5 listed)
- Pregnancy.
- Contraindication to local anesthesia.
- Patient with chronic pain, opioid consumption or alcohol consumption.
- Patient with coagulation trouble, hepatic dysfunction or renal dysfunction.
- Patient with diabetic or femoral neuropathy.
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 injectionSaphenous nerve block with 20ml of ropivacaine 0.5% and IPACK block with 30ml of ropivacaine 0.2% (total dose of 160 mg). | Drug | IPACK block |
| Ropivacaine injectionPeriarticular infiltration of 80 ml ropivacaine 0.2% (total dose of 160mg). | Drug | Local infiltration analgesia |
Primary outcome
Total morphine consumption (mg)
Time frame: 24 hours postoperatively
10 secondary outcomes
Total morphine consumption (mg)
Time frame: 2 hours, 48 hours and 72 hours postoperatively
Pain scores (numeric rating scale, 0-10) at rest and on movement
Time frame: 2hours, 24hours, 48hours and 72hours postoperatively
Rate of postoperative nausea and vomiting
Time frame: 2hours, 24hours, 48hours and 72hours postoperatively
Rate of antiemetic consumption
Time frame: 2hours, 24hours, 48hours and 72hours postoperatively
Rate of pruritus
Time frame: 2hours, 24hours, 48hours and 72hours postoperatively
Active flexion
Time frame: 24hours, 48hours and 72hours postoperatively
Quadriceps muscle strength (numeric scale, 1-5)
Time frame: 24hours, 48hours and 72hours postoperatively
Distance walked (meters)
Time frame: 24 hours, 48hours and 72hours postoperatively
Anterior Cruciate Ligament - Return to Sport after Injury survey
Time frame: 4 and 8 postoperative months
International Knee Documentation Committee score
Time frame: 4 and 8 postoperative months
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 27 Jan 2021.
- Derived from this study: PubMed 34039734Martin R, Kirkham KR, Ngo THN, Gonvers E, Lambert J, Albrecht E. Combination of femoral triangle block and infiltration between the popliteal artery and the capsule of the posterior knee (iPACK) versus local infiltration analgesia for analgesia after anterior cruciate ligament reconstruction: a randomized controlled triple-blinded trial. Reg Anesth Pain Med. 2021 Sep;46(9):763-768. doi: 10.1136/rapm-2021-102631. Epub 2021 May 26.
- Individual participant dataSharing planned: Undecided
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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.
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?
A study testing Ropivacaine injection in people with Postoperative Pain and Anterior Cruciate Ligament Injury, 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 2 inclusion and 5 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 27 Jan 2021. 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.
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 hours 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 NCT03680716, 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 27 Jan 2021.