Complications; ArthroplastyPhase 4NCT02100579
Ultrasound-guided Adductor Canal Block for Total Knee Replacement
A Phase 4 study testing Bupivacaine and Preservative free normal saline in people with Complications; Arthroplasty and Knee Injuries, run by Northwestern University at 1 site in United States.
Trial summary
Total knee arthroplasty is associated with intense early postoperative pain. Fast track recovery programs including early therapy protocols and early hospital discharge are being implemented at various hospitals. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Complications; Arthroplasty, Knee Injuries
- What is being tested?
- Bupivacaine and Preservative free normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Dec 2015
- Phase
- Phase 4
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants 40 to 75 years old who are presenting for minimally invasive total knee arthroplasty under spinal anesthesia
Who cannot join
- Patient refusal
- American Society of Anesthesiologists physical status classification of 4 or higher
- Pre-existing neuropathy in the femoral or sciatic distribution
- Coagulopathy
- Infection at the site
- Chronic opioid use (greater than 3 months)
Show all 9Show fewer
- Pregnancy
- Medical conditions limiting physical therapy participation
- Any other contra-indication to regional anesthesia
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
About this study
Official title: Ultrasound-guided Adductor Canal Block for Total Knee Replacement: a Randomized, Double-blind Placebo Controlled Trial.
Total knee arthroplasty is associated with intense early postoperative pain. Fast track recovery programs including early therapy protocols and early hospital discharge are being implemented at various hospitals. The postoperative analgesic pain regimen should enhance functional recovery in addition to providing efficient analgesia with minimal side effects. Adductor canal blockade is commonly used to provide postoperative analgesia for total knee arthroplasty (TKA) surgery. The investigators hypothesize that an ultrasound guided adductor canal block will lower narcotic consumption and improved overall satisfaction compared to ultrasound guided sham block with normal saline (placebo) for patients undergoing minimally invasive TKA surgery.
Read the detailed description
The investigators hypothesize that an ultrasound guided adductor canal block will lower narcotic consumption and improved overall satisfaction compared to ultrasound guided sham block with normal saline (placebo) for patients undergoing minimally invasive TKA surgery.
- Conditions
- Complications; Arthroplasty, Knee Injuries
- Being tested
- Bupivacaine, Preservative free normal saline
- Medical subject headings
- Knee Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
Also called Sensorcaine
10 ml of 0.25% bupivacaine
Preservative free normal salineDrug
Also called 0.9% sodium chloride
10 ml of preservative free normal saline
| Study group | Role | What they receive |
|---|---|---|
| Active Group | Active comparator | Ultrasound-guided adductor canal blockade with 10 ml of 0.25% bupivacaine Receives: Drug: Bupivacaine |
| Control Group | Placebo comparator | Ultrasound-guided sham block with 10 ml of preservative free normal saline Receives: Drug: Preservative free normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid Consumption (mg morEq)
Opioid consumption (morphine equivalents)
Measured: 36 hours
Secondary outcomes (2)
Visual Analog Scale Pain Score
Visual Analog Scale pain score; 0 = no pain, 10 = excruciating pain) in the knee recorded every 6 hours up to 36hrs following surgery.
Measured: Pain burden at 36hr
Length of Hospitalization
The average time to discharge in hours. Participants were discharged home went physical therapy criteria were met.
Measured: 0 to 192 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2014 (estimated)
- Study startMar 2014
- Primary completionOct 2015
- Study completionDec 2015
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 Complications; ArthroplastyStudies of the same condition, open and under way.
- More trials run by Northwestern 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antoun Nader, Northwestern University
- Investigators
- Antoun Nader, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02100579
- Sponsor's protocol ID
- STU00088239
- Other IDs
- STU00088239
- Status last verified
- Jun 2017
- First submitted
- 25 Mar 2014
- Last updated
- 11 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Adductor Canal Block for Total Knee Replacement: a Randomized, Double-blind Placebo Controlled Trial.
- ClinicalTrials.gov ID
- NCT02100579
- Acronym / sponsor ID
- STU00088239
- Conditions
- Complications; Arthroplasty, Knee Injuries
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 1 Apr 2014 (estimated)
- Results
- Posted 2 Nov 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Total knee arthroplasty is associated with intense early postoperative pain. Fast track recovery programs including early therapy protocols and early hospital discharge are being implemented at various hospitals. The postoperative analgesic pain regimen should enhance functional recovery in addition to providing efficient analgesia with minimal side effects. Adductor canal blockade is commonly used to provide postoperative analgesia for total knee arthroplasty (TKA) surgery. The investigators hypothesize that an ultrasound guided adductor canal block will lower narcotic consumption and improved overall satisfaction compared to ultrasound guided sham block with normal saline (placebo) for patients undergoing minimally invasive TKA surgery.
Detailed description
The investigators hypothesize that an ultrasound guided adductor canal block will lower narcotic consumption and improved overall satisfaction compared to ultrasound guided sham block with normal saline (placebo) for patients undergoing minimally invasive TKA 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 |
|---|---|---|
| Active Group | Active comparator | Drug: BupivacaineUltrasound-guided adductor canal blockade with 10 ml of 0.25% bupivacaine |
| Control Group | Placebo comparator | Drug: Preservative free normal salineUltrasound-guided sham block with 10 ml of preservative free normal saline |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants 40 to 75 years old who are presenting for minimally invasive total knee arthroplasty under spinal anesthesia
Key exclusion criteria (9 listed)
- Patient refusal
- American Society of Anesthesiologists physical status classification of 4 or higher
- Pre-existing neuropathy in the femoral or sciatic distribution
- Coagulopathy
- Infection at the site
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 |
|---|---|---|
| BupivacaineAlso: Sensorcaine10 ml of 0.25% bupivacaine | Drug | Active Group |
| Preservative free normal salineAlso: 0.9% sodium chloride10 ml of preservative free normal saline | Drug | Control Group |
Primary outcome
Opioid Consumption (mg morEq)
Time frame: 36 hours
Opioid consumption (morphine equivalents)
2 secondary outcomes
Visual Analog Scale Pain Score
Time frame: Pain burden at 36hr
Length of Hospitalization
Time frame: 0 to 192 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2017.
- 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.
Antoun Nader, MD principal investigator
Northwestern University
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 Bupivacaine and Preservative free normal saline in people with Complications; Arthroplasty and Knee Injuries, run by Northwestern 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 1 inclusion and 9 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 11 Jul 2017. 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. 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.
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?
Yes. Results are posted in the registry (first posted 2 Nov 2016). 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?
Opioid Consumption (mg morEq) (time frame: 36 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 11 Jul 2017.