Post-op PainNCT01939379
Adductor Canal Nerve Block Following Total Knee Arthroplasty
A study testing Morphine PCA started at the end of surgery, 1 Percocet 1/325mg every 4 hours; may receive a second Percocet if needed. and For the 30ml ropivacaine the intervention would be the subject can request extra pain medication which would be Percocet and/or morphine PCA. in people with Post-op Pain, run by Loma Linda University at 1 site in United States.
Trial summary
The purpose of this study is that an adductor canal nerve block (putting numbing medicine near the nerve) has been shown to produce excellent pain relief with less pain medication use after knee replacement surgery.The investigators will be comparing the amount of pain relief following knee replacement surgery when… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Post-op Pain
- What is being tested?
- Morphine PCA started at the end of surgery, 1 Percocet 1/325mg every 4 hours; may receive a second Percocet if needed. and For the 30ml ropivacaine the intervention would be the subject can request extra pain medication which would be Percocet and/or morphine PCA.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to 25 Jul 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Is the subject undergoing primary unilateral total knee arthroplasty?
- Is the subject 18 to 99 years of age?
- Is the subject ASA class 1, 2, or 3?
- Does the subject have a BMI less than 35?
- Can the subject consent in the English language?
Who cannot join
- Does subject have an allergy to drugs used in this study;
- Does subject have a daily intake of opiate medications that are considered stronger than hydrocodone?
- Does subject have a history of alcohol or drug abuse
- Has subject had a previous total knee arthroplasty?
- Has subject had any neurologic deficits in the lower extremity being studied?
Trial locations and contacts
1 site in 1 country.
United States1 site
Loma Linda University Medical Center East Campus Hospital
Loma Linda, California, 92354
About this study
Official title: Adductor Canal Nerve Block Following Total Knee Arthroplasty: A Randomized, Prospective Study Comparing High vs. Low Volume Bolus of 0.33% Ropivacaine
The purpose of this study is that an adductor canal nerve block (putting numbing medicine near the nerve) has been shown to produce excellent pain relief with less pain medication use after knee replacement surgery.The investigators will be comparing the amount of pain relief following knee replacement surgery when you have a nerve block in place. There will be approximately 66 subjects participating in this study. After surgery subjects will receive numbing medication every 6 hours for 48 hours. Subjects will also receive a morphine PCA (patient controlled analgesia) after surgery and pain medication by mouth every 4 hours around the clock with the option to receive more pain medication if needed. Subjects will participate in the study up to 3 days.
- Conditions
- Post-op Pain
- Being tested
- Morphine PCA started at the end of surgery, 1 Percocet 1/325mg every 4 hours; may receive a second Percocet if needed., For the 30ml ropivacaine the intervention would be the subject can request extra pain medication which would be Percocet and/or morphine PCA.
- Keywords
- Total knee arthroplasty, nerve block, Pain control after surgery
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Morphine PCA started at the end of surgery, 1 Percocet 1/325mg every 4 hours; may receive a second Percocet if needed.Drug
For the 30ml ropivacaine the intervention would be the subject can request extra pain medication which would be Percocet and/or morphine PCA.Drug
| Study group | Role | What they receive |
|---|---|---|
| 15ml ropivacaine | Active comparator | Depending on what dose of ropivacaine the subject is randomized to he/she could receive the 15ml dose injected into the catheter every 6 hours Receives: Drug: Morphine PCA started at the end of surgery, 1 Percocet 1/325mg every 4 hours; may receive a second Percocet if needed. |
| 30ml ropivacaine | Active comparator | If the subject is randomized to 30ml ropivacaine he/she will be injected through the catheter every 6 hours. Receives: Drug: For the 30ml ropivacaine the intervention would be the subject can request extra pain medication which would be Percocet and/or morphine PCA. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Opiate pain medication
At the end of the 48 hours period the total opiate pain medication taken will be collected and used for comparison as our primary outcome
Measured: The total amount of opiate pain medication will be recorded at 6 hour intervals for 48 hours after surgery.
Secondary outcomes (1)
Patient satisfaction with pain control
Secondary outcome measures will include demographic characteristics, pain scores, medication administration,patient satisfaction with pain control and any complications that may have arisen. We will also record the location of the adductor canal catheter on the final bolus dose.
Measured: We will look at the secondary outcome measure beginning every six hours for 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2013 (estimated)
- Study startSep 2013
- Primary completion25 Jul 2017
- Study completion25 Jul 2017
Why it stopped: PI left institution. Efforts made to contact PI unsuccessful. No study data available.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-op PainStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe 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
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01939379
- Sponsor's protocol ID
- 5130183
- Status last verified
- Apr 2021
- First submitted
- 3 Sep 2013
- Last updated
- 20 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adductor Canal Nerve Block Following Total Knee Arthroplasty: A Randomized, Prospective Study Comparing High vs. Low Volume Bolus of 0.33% Ropivacaine
- ClinicalTrials.gov ID
- NCT01939379
- Acronym / sponsor ID
- 5130183
- Conditions
- Post-op Pain
- Keywords
- Total knee arthroplasty, nerve block, Pain control after surgery
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI left institution. Efforts made to contact PI unsuccessful. No study data available.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- 25 Jul 2017 (actual)
- Study completion
- 25 Jul 2017 (actual)
- First posted
- 11 Sep 2013 (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 purpose of this study is that an adductor canal nerve block (putting numbing medicine near the nerve) has been shown to produce excellent pain relief with less pain medication use after knee replacement surgery.The investigators will be comparing the amount of pain relief following knee replacement surgery when you have a nerve block in place. There will be approximately 66 subjects participating in this study. After surgery subjects will receive numbing medication every 6 hours for 48 hours. Subjects will also receive a morphine PCA (patient controlled analgesia) after surgery and pain medication by mouth every 4 hours around the clock with the option to receive more pain medication if needed. Subjects will participate in the study up to 3 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 15ml ropivacaine | Active comparator | Drug: Morphine PCA started at the end of surgery, 1 Percocet 1/325mg every 4 hours; may receive a second Percocet if needed.Depending on what dose of ropivacaine the subject is randomized to he/she could receive the 15ml dose injected into the catheter every 6 hours |
| 30ml ropivacaine | Active comparator | Drug: For the 30ml ropivacaine the intervention would be the subject can request extra pain medication which would be Percocet and/or morphine PCA.If the subject is randomized to 30ml ropivacaine he/she will be injected through the catheter every 6 hours. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Is the subject undergoing primary unilateral total knee arthroplasty?
- Is the subject 18 to 99 years of age?
- Is the subject ASA class 1, 2, or 3?
- Does the subject have a BMI less than 35?
- Can the subject consent in the English language?
Key exclusion criteria (5 listed)
- Does subject have an allergy to drugs used in this study;
- Does subject have a daily intake of opiate medications that are considered stronger than hydrocodone?
- Does subject have a history of alcohol or drug abuse
- Has subject had a previous total knee arthroplasty?
- Has subject had any neurologic deficits in the lower extremity being studied?
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 |
|---|---|---|
| Morphine PCA started at the end of surgery, 1 Percocet 1/325mg every 4 hours; may receive a second Percocet if needed. | Drug | 15ml ropivacaine |
| For the 30ml ropivacaine the intervention would be the subject can request extra pain medication which would be Percocet and/or morphine PCA. | Drug | 30ml ropivacaine |
Primary outcome
Total Opiate pain medication
Time frame: The total amount of opiate pain medication will be recorded at 6 hour intervals for 48 hours after surgery.
At the end of the 48 hours period the total opiate pain medication taken will be collected and used for comparison as our primary outcome
1 secondary outcome
Patient satisfaction with pain control
Time frame: We will look at the secondary outcome measure beginning every six hours for 48 hours after surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2021.
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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 Morphine PCA started at the end of surgery, 1 Percocet 1/325mg every 4 hours; may receive a second Percocet if needed. and For the 30ml ropivacaine the intervention would be the subject can request extra pain medication which would be Percocet and/or morphine PCA. in people with Post-op Pain, run by Loma Linda University 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 5 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: withdrawn, as of the sponsor's last update on 20 Apr 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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 Opiate pain medication (time frame: The total amount of opiate pain medication will be recorded at 6 hour intervals for 48 hours after surgery.). 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 20 Apr 2021.