Knee OsteoarthritisPhase 4NCT03326999
Does Adding an Additional Numbing Medication Injection in the Thigh Help With Pain Control After Knee Replacement Surgery?
A Phase 4 study testing Obturator nerve regional block, Adductor canal regional block and Saline in people with Knee Osteoarthritis and Knee Rheumatism, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
One common anesthetic that is performed for total knee replacement surgery is spinal anesthesia with an adductor canal regional block, which involves injecting numbing medication in the thigh region for pain control after surgery. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Knee Osteoarthritis, Knee Rheumatism
- What is being tested?
- Obturator nerve regional block, Adductor canal regional block and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Dec 2017to 18 Dec 2018
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled to undergo total knee arthroplasty
- Planned use of regional anesthesia for procedure
- Willing and able to provide informed consent
Who cannot join
- Patients on immunosuppressive therapy
- Patients with history of diabetes
- Patients with lower limb neuropathy
- Patients with history of chronic opioid use for > 3 months, including but not limited to, fentanyl, morphine, oxycodone, methadone
- Patients with known allergy or intolerance to any drug used in the study
- Patients with history of alcohol or drug abuse
Show all 9Show fewer
- Patients with history of intolerance of nonsteroidal anti-inflammatory drugs
- Patients with hepatic or renal insufficiency
- ASA score of 4 or greater
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: Evaluating the Addition of Obturator Nerve Block to Adductor Canal Block for Total Knee Arthroplasty
One common anesthetic that is performed for total knee replacement surgery is spinal anesthesia with an adductor canal regional block, which involves injecting numbing medication in the thigh region for pain control after surgery. The aim of this study is to determine whether the addition of another regional block called obturator nerve block, which involves injecting numbing medication in the upper thigh region, will improve pain control after surgery while not sacrificing mobility after surgery.
Read the detailed description
There is currently no consensus on the optimal strategy that provides the most effective postoperative analgesia while preserving ambulation and limiting side effects such as nausea and vomiting. The clinical team's hypothesis is that the obturator nerve block in addition to adductor canal block can target both the anterior and posterior distribution of nerves to the knee to provide superior analgesia while not limiting ambulation. To test this hypothesis, the clinical team will compare the rate of IV opioid consumption in patients who receive a combination of adductor canal block and obturator nerve block at the surgical site versus patients who receive adductor canal block alone.
- Conditions
- Knee Osteoarthritis, Knee Rheumatism
- Being tested
- Obturator nerve regional block, Adductor canal regional block, Saline
- Keywords
- adductor canal regional block, obturator nerve regional block, total knee arthroplasty, knee replacement surgery, Knee rheumatoid arthritis
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Obturator nerve regional blockDrug
Also called bupivacaine
Obturator nerve regional block involves the injection of a local anesthetic called bupivacaine into the upper thigh.
Adductor canal regional blockDrug
Adductor canal regional block, which involves injecting numbing medication in the thigh region for pain control.
SalineDrug
Saline as placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| Investigational arm | Experimental | Patients in this arm will receive adductor canal regional block with bupivacaine and obturator nerve regional block with bupivacaine Receives: Drug: Obturator nerve regional block; Drug: Adductor canal regional block |
| Control arm | Sham comparator | Patients in this arm will receive adductor canal regional block with bupivacaine and obturator nerve regional block with saline Receives: Drug: Adductor canal regional block; Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine Equivalence Consumption
Total amount of opioids consumed
Measured: up to 24 hours after surgery
Secondary outcomes (5)
Pain Score
Likert scale ranging from 0-10 - 0 being no pain, and 10 being the worst pain ever experienced
Measured: 1, 6, 12, and 24 hours after surgery
Number of Participants With Nausea or Vomiting
Yes or No responses when the subject is asked if the subject is feeling nauseous or has vomited
Measured: up to 24 hours after surgery
Time to Ambulation
The length of time that it takes before the patient is first able to walk with assistance after surgery as assessed by a physical therapist.
Measured: on postoperative day 1 after surgery
Time to Breakthrough Pain Medication
Time before pain medication needed for breakthrough pain
Measured: up to post operative day 2 after surgery
Analgesia Satisfaction Score
Analgesia Satisfaction Score - Full scale from 0-10 with higher score indicating higher satisfaction.
Measured: 2 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2017
- Study start11 Dec 2017
- Primary completion18 Dec 2018
- Study completion18 Dec 2018
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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
- Model description
- Randomized controlled trial with two arms: one arm will receive adductor canal block and obturator nerve block with the local anesthetic bupivacaine; second arm will receive adductor canal block with bupivacaine and obturator nerve block with saline.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christina Jeng, Icahn School of Medicine at Mount Sinai
- Investigators
- Christina Jeng, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03326999
- Sponsor's protocol ID
- GCO 17-2153
- Status last verified
- Sep 2020
- First submitted
- 27 Oct 2017
- Last updated
- 30 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Runge C, Borglum J, Jensen JM, Kobborg T, Pedersen A, Sandberg J, Mikkelsen LR, Vase M, Bendtsen TF. The Analgesic Effect of Obturator Nerve Block Added to a Femoral Triangle Block After Total Knee Arthroplasty: A Randomized Controlled Trial. Reg Anesth Pain Med. 2016 Jul-Aug;41(4):445-51. doi: 10.1097/AAP.0000000000000406.
PubMed 27171822
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Addition of Obturator Nerve Block to Adductor Canal Block for Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT03326999
- Acronym / sponsor ID
- GCO 17-2153
- Conditions
- Knee Osteoarthritis, Knee Rheumatism
- Keywords
- adductor canal regional block, obturator nerve regional block, total knee arthroplasty, knee replacement surgery, Knee rheumatoid arthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 11 Dec 2017 (actual)
- Primary completion
- 18 Dec 2018 (actual)
- Study completion
- 18 Dec 2018 (actual)
- First posted
- 31 Oct 2017 (actual)
- Results
- Posted 26 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
One common anesthetic that is performed for total knee replacement surgery is spinal anesthesia with an adductor canal regional block, which involves injecting numbing medication in the thigh region for pain control after surgery. The aim of this study is to determine whether the addition of another regional block called obturator nerve block, which involves injecting numbing medication in the upper thigh region, will improve pain control after surgery while not sacrificing mobility after surgery.
Detailed description
There is currently no consensus on the optimal strategy that provides the most effective postoperative analgesia while preserving ambulation and limiting side effects such as nausea and vomiting. The clinical team's hypothesis is that the obturator nerve block in addition to adductor canal block can target both the anterior and posterior distribution of nerves to the knee to provide superior analgesia while not limiting ambulation. To test this hypothesis, the clinical team will compare the rate of IV opioid consumption in patients who receive a combination of adductor canal block and obturator nerve block at the surgical site versus patients who receive adductor canal block alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial with two arms: one arm will receive adductor canal block and obturator nerve block with the local anesthetic bupivacaine; second arm will receive adductor canal block with bupivacaine and obturator nerve block with saline.
| Arm | Type | Receives |
|---|---|---|
| Investigational arm | Experimental | Drug: Obturator nerve regional block, Drug: Adductor canal regional blockPatients in this arm will receive adductor canal regional block with bupivacaine and obturator nerve regional block with bupivacaine |
| Control arm | Sham comparator | Drug: Adductor canal regional block, Drug: SalinePatients in this arm will receive adductor canal regional block with bupivacaine and obturator nerve regional block with saline |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients scheduled to undergo total knee arthroplasty
- Planned use of regional anesthesia for procedure
- Willing and able to provide informed consent
Key exclusion criteria (9 listed)
- Patients on immunosuppressive therapy
- Patients with history of diabetes
- Patients with lower limb neuropathy
- Patients with history of chronic opioid use for > 3 months, including but not limited to, fentanyl, morphine, oxycodone, methadone
- Patients with known allergy or intolerance to any drug used in the study
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 |
|---|---|---|
| Obturator nerve regional blockAlso: bupivacaineObturator nerve regional block involves the injection of a local anesthetic called bupivacaine into the upper thigh. | Drug | Investigational arm |
| Adductor canal regional blockAdductor canal regional block, which involves injecting numbing medication in the thigh region for pain control. | Drug | Control arm, Investigational arm |
| SalineSaline as placebo comparator | Drug | Control arm |
Primary outcome
Morphine Equivalence Consumption
Time frame: up to 24 hours after surgery
Total amount of opioids consumed
5 secondary outcomes
Pain Score
Time frame: 1, 6, 12, and 24 hours after surgery
Number of Participants With Nausea or Vomiting
Time frame: up to 24 hours after surgery
Time to Ambulation
Time frame: on postoperative day 1 after surgery
Time to Breakthrough Pain Medication
Time frame: up to post operative day 2 after surgery
Analgesia Satisfaction Score
Time frame: 2 weeks after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27171822Runge C, Borglum J, Jensen JM, Kobborg T, Pedersen A, Sandberg J, Mikkelsen LR, Vase M, Bendtsen TF. The Analgesic Effect of Obturator Nerve Block Added to a Femoral Triangle Block After Total Knee Arthroplasty: A Randomized Controlled Trial. Reg Anesth Pain Med. 2016 Jul-Aug;41(4):445-51. doi: 10.1097/AAP.0000000000000406.
- 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.
Christina Jeng, MD principal investigator
Icahn School of Medicine at Mount Sinai
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 Obturator nerve regional block, Adductor canal regional block and Saline in people with Knee Osteoarthritis and Knee Rheumatism, run by Icahn School of Medicine at Mount Sinai 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 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 30 Sep 2020. 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 26 Aug 2020). 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?
Morphine Equivalence Consumption (time frame: up to 24 hours after surgery). 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 NCT03326999, 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 30 Sep 2020.