Pain, PostoperativeNCT05080348
Effectiveness of iPACK on Postoperative Pain From Hamstring Autograft Following ACL Repair
A study testing Ropivacaine iPACK Injection and Normal Saline iPACK Injection in people with Pain, Postoperative and ACL Injury, run by Brenton Alexander.
Trial summary
Patients undergoing ACL repair with hamstring autograft frequently develop significant post operative pain at the hamstring grafting site. This pain is within the distribution of a commonly used regional nerve block, the Interspace between the popliteal artery and capsule of the knee (iPACK). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative, ACL Injury, Anesthesia, Local
- What is being tested?
- Ropivacaine iPACK Injection and Normal Saline iPACK Injection
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Dec 2021to May 2022
- 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
- Undergoing ACL surgery with expected Hamstring Autograft by Dr. Catherine Robertson at UC San Diego
- At least 18 years of age
- Able to Provide Consent in English prior to Surgery
Who cannot join
- Pregnancy (a urine pregnancy test is standard at UCSD for female patients prior to menopause who are sexually active with the opposite sex within the previous year)
- Inability to communicate with the investigators and hospital staff
- Severe renal, hepatic or cardiac disease
- Chronic high-dose opioid use (defined as daily use for more than 4 weeks prior to surgery of at least the equivalent of 20 mg oxycodone)
- BMI > 45 kg/m2
- Allergy to study medications (lidocaine, bupivacaine)
- Incarceration.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effectiveness of Preoperative iPACK on Postoperative Pain From Hamstring Autograft for ACL Repair
Patients undergoing ACL repair with hamstring autograft frequently develop significant post operative pain at the hamstring grafting site. This pain is within the distribution of a commonly used regional nerve block, the Interspace between the popliteal artery and capsule of the knee (iPACK). The investigators plan to randomize consenting patients to either receiving a SHAM injection of normal saline or to an interventional group of long acting local anesthetic (Ropivacaine) injected in the popliteal fossa between the popliteal artery and capsule of the knee (iPACK). Both groups of patients will receive standard of care with respect to perioperative pain management, which includes a preoperative adductor canal nerve block and preoperative acetaminophen administration. Dual primary endpoints of postoperative pain scores and mean postoperative opioid use will be retrieved and compared between groups. Additional secondary endpoints will be PACU length of stay, PACU opioid use, POD1 opioids use, and POD1 pain scores (best, worst, average).
- Conditions
- Pain, Postoperative, ACL Injury, Anesthesia, Local, Opioid Use
- Being tested
- Ropivacaine iPACK Injection, Normal Saline iPACK 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 iPACK InjectionProcedure or surgery
Injection of 20mL of 0.25% Ropivacaine with 1:400,000 Epinephrine between in the Interspace between the Popliteal Artery and the Capsule of the Knee (iPACK) using ultrasound guidance at the level of the femoral condyles
Normal Saline iPACK InjectionProcedure or surgery
Injection of 20mL of 0.9% Normal Saline between in the Interspace between the Popliteal Artery and the Capsule of the Knee (iPACK) using ultrasound guidance at the level of the femoral condyles
| Study group | Role | What they receive |
|---|---|---|
| Ropivacaine iPACK | Active comparator | Patient will receive standard of care for perioperative pain management. In addition, they will receive a single preoperative injection of 20cc of 0.25% Ropivacaine with 1:400,000 epinephrine in the Interspace between the Popliteal Artery and Capsule of the Knee (iPACK). Receives: Procedure: Ropivacaine iPACK Injection |
| Normal Saline iPACK | Sham comparator | Patient will receive standard of care for perioperative pain management. In addition, they will receive a single preoperative injection of 20cc of 0.9% Normal Saline in the Interspace between the Popliteal Artery and Capsule of the Knee (iPACK). Receives: Procedure: Normal Saline iPACK Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Post Anesthesia Recovery Unit (PACU) Pain Score
Median pain score collected in the PACU following surgery on a scale of 1-10 (1 being no pain, 10 being the worst pain the patient has ever experienced)
Measured: From arrival in PACU until patient has been cleared for PACU discharge
Total Perioperative Opioid Use (Morphine equivalents)
Intraoperative and Post Operative (in the PACU) opioid use
Measured: From time of the start of surgery until time that patient meets PACU discharge criteria
Secondary outcomes (4)
PACU Length of Stay (days)
Length of stay from PACU arrival to "ready for discharge" criteria are met
Measured: From PACU arrival until criteria for PACU discharge are met
PACU Opioid Use (Morphine equivalents)
All opioid use in the PACU
Measured: From PACU arrival until criteria for PACU discharge are met
Postoperative Day (POD) 1 Opioid Use (Morphine Equivalents)
All Opioid use in the approximate 24 hours following PACU Discharge
Measured: Time of discharge from PACU until 24 hours after PACU discharge
Best, Worst, Average Pain Scores on POD 1
Best, Worst and Average pain scores collected on POD 1 following surgery on a scale of 1-10 (1 being no pain, 10 being the worst pain the patient has ever experienced)
Measured: For the entire length of post operative day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2021
- Study startDec 2021 (estimated)
- Primary completionApr 2022 (estimated)
- Study completionMay 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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
- Model description
- Randomized double blind placebo controlled
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brenton Alexander
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Brenton Alexander, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05080348
- Sponsor's protocol ID
- iPACK ACL Hamstring Autograft
- Status last verified
- Oct 2021
- First submitted
- 7 Sep 2021
- Last updated
- 15 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Preoperative iPACK on Postoperative Pain From Hamstring Autograft for ACL Repair
- ClinicalTrials.gov ID
- NCT05080348
- Acronym / sponsor ID
- iPACK ACL Hamstring Autograft
- Conditions
- Pain, Postoperative, ACL Injury, Anesthesia, Local, Opioid Use
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Brenton AlexanderUniversity, hospital or other
- Study start
- Dec 2021 (estimated)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 15 Oct 2021 (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.
Patients undergoing ACL repair with hamstring autograft frequently develop significant post operative pain at the hamstring grafting site. This pain is within the distribution of a commonly used regional nerve block, the Interspace between the popliteal artery and capsule of the knee (iPACK). The investigators plan to randomize consenting patients to either receiving a SHAM injection of normal saline or to an interventional group of long acting local anesthetic (Ropivacaine) injected in the popliteal fossa between the popliteal artery and capsule of the knee (iPACK). Both groups of patients will receive standard of care with respect to perioperative pain management, which includes a preoperative adductor canal nerve block and preoperative acetaminophen administration. Dual primary endpoints of postoperative pain scores and mean postoperative opioid use will be retrieved and compared between groups. Additional secondary endpoints will be PACU length of stay, PACU opioid use, POD1 opioids use, and POD1 pain scores (best, worst, average).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Randomized double blind placebo controlled
| Arm | Type | Receives |
|---|---|---|
| Ropivacaine iPACK | Active comparator | Procedure: Ropivacaine iPACK InjectionPatient will receive standard of care for perioperative pain management. In addition, they will receive a single preoperative injection of 20cc of 0.25% Ropivacaine with 1:400,000 epinephrine in the Interspace between the Popliteal Artery and Capsule of the Knee (iPACK). |
| Normal Saline iPACK | Sham comparator | Procedure: Normal Saline iPACK InjectionPatient will receive standard of care for perioperative pain management. In addition, they will receive a single preoperative injection of 20cc of 0.9% Normal Saline in the Interspace between the Popliteal Artery and Capsule of the Knee (iPACK). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Undergoing ACL surgery with expected Hamstring Autograft by Dr. Catherine Robertson at UC San Diego
- At least 18 years of age
- Able to Provide Consent in English prior to Surgery
Key exclusion criteria (7 listed)
- Pregnancy (a urine pregnancy test is standard at UCSD for female patients prior to menopause who are sexually active with the opposite sex within the previous year)
- Inability to communicate with the investigators and hospital staff
- Severe renal, hepatic or cardiac disease
- Chronic high-dose opioid use (defined as daily use for more than 4 weeks prior to surgery of at least the equivalent of 20 mg oxycodone)
- BMI > 45 kg/m2
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 iPACK InjectionInjection of 20mL of 0.25% Ropivacaine with 1:400,000 Epinephrine between in the Interspace between the Popliteal Artery and the Capsule of the Knee (iPACK) using ultrasound guidance at the level of the femoral condyles | Procedure or surgery | Ropivacaine iPACK |
| Normal Saline iPACK InjectionInjection of 20mL of 0.9% Normal Saline between in the Interspace between the Popliteal Artery and the Capsule of the Knee (iPACK) using ultrasound guidance at the level of the femoral condyles | Procedure or surgery | Normal Saline iPACK |
Primary outcome
Median Post Anesthesia Recovery Unit (PACU) Pain Score
Time frame: From arrival in PACU until patient has been cleared for PACU discharge
Median pain score collected in the PACU following surgery on a scale of 1-10 (1 being no pain, 10 being the worst pain the patient has ever experienced)
Total Perioperative Opioid Use (Morphine equivalents)
Time frame: From time of the start of surgery until time that patient meets PACU discharge criteria
Intraoperative and Post Operative (in the PACU) opioid use
4 secondary outcomes
PACU Length of Stay (days)
Time frame: From PACU arrival until criteria for PACU discharge are met
PACU Opioid Use (Morphine equivalents)
Time frame: From PACU arrival until criteria for PACU discharge are met
Postoperative Day (POD) 1 Opioid Use (Morphine Equivalents)
Time frame: Time of discharge from PACU until 24 hours after PACU discharge
Best, Worst, Average Pain Scores on POD 1
Time frame: For the entire length of post operative day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2021.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Ropivacaine iPACK Injection and Normal Saline iPACK Injection in people with Pain, Postoperative and ACL Injury, run by Brenton Alexander.
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 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: status not confirmed, as of the sponsor's last update on 15 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Brenton Alexander, MD ((858) 657-7000, bsalexander@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median Post Anesthesia Recovery Unit (PACU) Pain Score (time frame: From arrival in PACU until patient has been cleared for PACU discharge). The study lists 2 primary outcomes in all. 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 15 Oct 2021.