Anterior Cruciate Ligament TearPhase 3NCT03983941
IPACK Versus Popliteal Sciatic Nerve Block in ACL Reconstruction
A Phase 3 study testing Ropivacaine injection in people with Anterior Cruciate Ligament Tear, run by Sujana Dontukurthy at 1 site in United States.
Trial summary
This is a prospective study comparing femoral nerve block plus sciatic nerve block to femoral nerve block plus infiltration of the posterior knee capsule (IPACK) in patients undergoing arthroscopic anterior cruciate ligament reconstruction. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Anterior Cruciate Ligament Tear
- 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
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2019to 7 Nov 2019
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients less than 21 years of age
- American Society of Anesthesiologists physical status I and II
- Undergoing elective anterior cruciate ligament reconstruction
Who cannot join
- They are unable or unwilling to take part in the study
- History of allergy to any of the medications administered for the nerve block
- Contraindication to peripheral nerve block
- Patients who are unable to understand instructions or questions related to the study or the families required language interpretation
- Patients who consume opioid medications for more than three days per week for more than a month prior to surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
Official title: Comparison of Postoperative Analgesic Efficacy of Adductor Canal Block With IPACK Versus Adductor Canal and Popliteal Sciatic Nerve Block in Patients Undergoing Arthroscopic Anterior Cruciate Ligament Reconstruction
This is a prospective study comparing femoral nerve block plus sciatic nerve block to femoral nerve block plus infiltration of the posterior knee capsule (IPACK) in patients undergoing arthroscopic anterior cruciate ligament reconstruction. Femoral nerve block via the adductor canal (FNB-AC) with IPACK may provide effective analgesia while avoiding the motor block involved with sciatic nerve block. The lack of motor block is important to facilitate postoperative ambulation and physical therapy.
- Conditions
- Anterior Cruciate Ligament Tear
- Being tested
- Ropivacaine injection
- 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 injectionDrug
Total dose not to exceed 3 mg/kg of ropivacaine.
| Study group | Role | What they receive |
|---|---|---|
| FNB-AC + Sciatic nerve block | Active comparator | Patients will receive up to 20 mL of 0.2% ropivacaine for FNB-AC and up to 20 mL of 0.2% ropivacaine for sciatic nerve block under ultrasound guidance. Receives: Drug: Ropivacaine injection |
| FNB-AC + IPACK | Experimental | Patients will receive up to 20 mL of 0.2% ropivacaine for FNB-AC and up to 20 mL of 0.2% ropivacaine for posterior knee capsular infiltration under ultrasound guidance (IPACK) Receives: Drug: Ropivacaine injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Post-operative Pain Score
Visual Analogue Scale (VAS) pain scores (0 being no pain and 10 being worst pain) from arrival to post-anesthesia care unit (PACU) to 48 hours after discharge from surgery center.
Measured: Immediately post-operatively and up to 48 hours post-discharge, an average of 48 hours
Secondary outcomes (1)
Number of Opioid Doses Administered
Number of doses of narcotic pain medicine administered during surgery and up to 48 hours after discharge from surgery center.
Measured: Intra-operative and up to 48 hours post-discharge, an average of 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2019
- Study start30 Aug 2019
- Primary completion7 Nov 2019
- Study completion7 Nov 2019
Why it stopped: PI leaving the institution, no subjects enrolled since 2019, and no other PI interested in taking it over.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Anterior Cruciate Ligament TearStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sujana Dontukurthy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sujana Dontukurthy, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03983941
- Sponsor's protocol ID
- STUDY00000281
- Status last verified
- Aug 2021
- First submitted
- 10 Jun 2019
- Last updated
- 16 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Postoperative Analgesic Efficacy of Adductor Canal Block With IPACK Versus Adductor Canal and Popliteal Sciatic Nerve Block in Patients Undergoing Arthroscopic Anterior Cruciate Ligament Reconstruction
- ClinicalTrials.gov ID
- NCT03983941
- Acronym / sponsor ID
- STUDY00000281
- Conditions
- Anterior Cruciate Ligament Tear
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI leaving the institution, no subjects enrolled since 2019, and no other PI interested in taking it over.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Sujana DontukurthyUniversity, hospital or other
- Study start
- 30 Aug 2019 (actual)
- Primary completion
- 7 Nov 2019 (actual)
- Study completion
- 7 Nov 2019 (actual)
- First posted
- 12 Jun 2019 (actual)
- Results
- Posted 16 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective study comparing femoral nerve block plus sciatic nerve block to femoral nerve block plus infiltration of the posterior knee capsule (IPACK) in patients undergoing arthroscopic anterior cruciate ligament reconstruction. Femoral nerve block via the adductor canal (FNB-AC) with IPACK may provide effective analgesia while avoiding the motor block involved with sciatic nerve block. The lack of motor block is important to facilitate postoperative ambulation and physical therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FNB-AC + Sciatic nerve block | Active comparator | Drug: Ropivacaine injectionPatients will receive up to 20 mL of 0.2% ropivacaine for FNB-AC and up to 20 mL of 0.2% ropivacaine for sciatic nerve block under ultrasound guidance. |
| FNB-AC + IPACK | Experimental | Drug: Ropivacaine injectionPatients will receive up to 20 mL of 0.2% ropivacaine for FNB-AC and up to 20 mL of 0.2% ropivacaine for posterior knee capsular infiltration under ultrasound guidance (IPACK) |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patients less than 21 years of age
- American Society of Anesthesiologists physical status I and II
- Undergoing elective anterior cruciate ligament reconstruction
Key exclusion criteria (5 listed)
- They are unable or unwilling to take part in the study
- History of allergy to any of the medications administered for the nerve block
- Contraindication to peripheral nerve block
- Patients who are unable to understand instructions or questions related to the study or the families required language interpretation
- Patients who consume opioid medications for more than three days per week for more than a month prior to surgery
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 injectionTotal dose not to exceed 3 mg/kg of ropivacaine. | Drug | FNB-AC + IPACK, FNB-AC + Sciatic nerve block |
Primary outcome
Average Post-operative Pain Score
Time frame: Immediately post-operatively and up to 48 hours post-discharge, an average of 48 hours
Visual Analogue Scale (VAS) pain scores (0 being no pain and 10 being worst pain) from arrival to post-anesthesia care unit (PACU) to 48 hours after discharge from surgery center.
1 secondary outcome
Number of Opioid Doses Administered
Time frame: Intra-operative and up to 48 hours post-discharge, an average of 48 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
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 Phase 3 study testing Ropivacaine injection in people with Anterior Cruciate Ligament Tear, run by Sujana Dontukurthy at 1 site in United States.
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 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: stopped early, as of the sponsor's last update on 16 Sep 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 United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Average Post-operative Pain Score (time frame: Immediately post-operatively and up to 48 hours post-discharge, an average of 48 hours). 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 16 Sep 2021.