Postoperative PainPhase 4NCT03316118
US Guided GNB vs Saline Injection for TKA
A Phase 4 study testing bupivacaine and saline in people with Postoperative Pain and Total Knee Arthroplasty, run by Northwestern University at 1 site in United States.
Trial summary
Do ultrasound-guided genicular nerve blocks with 0.5% bupivacaine provide improved knee analgesia for patients recovering from total knee replacement surgery compared to saline injection? Hypotheses: The investigators hypothesize that the combination of ultrasound-guided adductor canal block (ACB) and genicular nerve… Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Postoperative Pain, Total Knee Arthroplasty, Nerve Block
- What is being tested?
- bupivacaine and saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2017to 21 Jun 2021
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants 40 to 85 years old who are presenting for minimally invasive total knee arthroplasty under spinal anesthesia and are candidates for peripheral nerve blocks.
- Minimally invasive is defined as custom modified instrumentation, a quadriceps sparing arthrotomy that does not extend beyond 1cm proximal to the patella and surgical techniques that focus on soft tissue protection.
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.
About this study
Official title: A Comparison of Analgesic Efficacy of Ultrasound-Guided Genicular Nerve Block Versus Saline Injection for Total Knee Replacement: a Prospective, Randomized Controlled Trial
Do ultrasound-guided genicular nerve blocks with 0.5% bupivacaine provide improved knee analgesia for patients recovering from total knee replacement surgery compared to saline injection?
Hypotheses:
The investigators hypothesize that the combination of ultrasound-guided adductor canal block (ACB) and genicular nerve block will achieve lower opioid consumption and therefore lead to decreased systemic side effects and improved overall satisfaction compared to ultrasound-guided saline injection for patients undergoing minimally invasive elective total knee arthroplasty (TKA).
Read the detailed description
The study medication and protocol will consist of Group 1 (Active) - ultrasound-guided adductor canal blockade with 10 ml of 0.25% bupivacaine and ultrasound-guided genicular nerve blocks with 6 ml of 0.5% bupivacaine, and Group 2 (Control) - ultrasound-guided adductor canal block with 10 ml of 0.25% bupivacaine and ultrasound-guided genicular nerve blocks with 6 ml of normal saline. The surgeon will be blinded to the subjects study arm assignment.
An ultrasound-guided ACB will be performed at the level of the mid-thigh of the leg halfway between the superior anterior iliac spine and the patella. The femoral artery, femoral vein, saphenous nerve will be visualized by ultrasonography and the expansion of the adductor canal will be recorded. Sensory assessment of the saphenous distribution will be performed at 30 minutes. The ultrasound-guided genicular nerve block will be performed at the site of the superior lateral, the superior medial, and the inferior medial genicular nerves. The superior lateral genicular nerve is located at the confluence of the lateral femoral shaft and the lateral femoral condyle (in the anteroposterior plane) and at the midpoint of the femur (in the lateral plane). The superior medial genicular nerve site is located at the confluence of the medial femoral shaft and the medial femoral condyle (in the anteroposterior plane) and at the midpoint of the femur (in the lateral plane). The inferior medial genicular nerve site is located at the confluence of the medial tibial shaft and the tibial flare (in the anteroposterior plane) and the midpoint of the tibia (in the lateral plane). Color Doppler will be used to identify the arterial structures which serve as landmarks for the corresponding nerves. All nerve blocks will be performed by a study team physician.
Postoperative follow-up will be done by study team member blinded to the group allocation. The dosing of oxycodone/hydrocodone-acetaminophen will be as needed with management goal of a Visual Analog Scale (VAS) score of ≤ 4. Patients with pain not managed by oral agents will receive IV medication. Patients will be visited during their hospital stay every six hours until discharge to record pain scores, opioid consumption, and patient satisfaction. In addition, patients will be given a pain diary to record (VAS) pain scores every six hours until hospital discharge.
A study team member will follow up patients by telephone (if discharged prior to) at 48 hours, 72 hours.
- Conditions
- Postoperative Pain, Total Knee Arthroplasty, Nerve Block
- Being tested
- bupivacaine, saline
- Keywords
- anesthesiology, pain, arthroplasty
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bupivacaineDrug
Also called BUPIV
Group 1 will receive genicular nerve block using bupivacaine
salineDrug
Also called SAL
Group 2 will receive genicular nerve block using normal saline
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Patient will receive genicular nerve block with bupivacaine Receives: Drug: bupivacaine |
| Group 2 | Placebo comparator | Patient will receive normal saline as the nerve block Receives: Drug: saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative Opioid Consumption During the Hospital Stay
Post-operative opioid consumption measured in morphine milligram equivalents (MME)during the hospital stay up to 36 hours after surgery.
Measured: 36 hours after surgery
Secondary outcomes (3)
Mean Pain Scores of the Knee at Rest for the First 48 Hours After Surgery
Mean pain scores post operative reported using the VAS (visual analog scale) for knee pain at rest on a scale of 0 (no pain to 10 worst pain imaginable). This will be assessed every 6 hours up to 48 hours with the visual analog scale where 0 equals no pain and 10 represents excruciating pain.
Measured: 48 hours after surgery
Overall Satisfaction With Pain Control 72 Hours After Surgery
Overall satisfaction with pain control 72 hours after surgery using a visual analog scale where 0 = not satisfied and 10 being extremely satisfied
Measured: 72 hours after surgery
Length of Hospitalization
Length of hospitalization in hours from time to admission to time of discharge.
Measured: Admission to discharge from hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2017
- Study start5 Oct 2017
- Primary completion21 Jun 2021
- Study completion21 Jun 2021
Why it stopped: Low Enrollment
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 Postoperative PainStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 2 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 M Nader, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03316118
- Sponsor's protocol ID
- STU#:00204116
- Status last verified
- Sep 2022
- First submitted
- 5 Oct 2017
- Last updated
- 28 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Analgesic Efficacy of Ultrasound-Guided Genicular Nerve Block Versus Saline Injection for Total Knee Replacement: a Prospective, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03316118
- Acronym / sponsor ID
- STU#:00204116
- Conditions
- Postoperative Pain, Total Knee Arthroplasty, Nerve Block
- Keywords
- anesthesiology, pain, arthroplasty
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low Enrollment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 5 Oct 2017 (actual)
- Primary completion
- 21 Jun 2021 (actual)
- Study completion
- 21 Jun 2021 (actual)
- First posted
- 20 Oct 2017 (actual)
- Results
- Posted 28 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Do ultrasound-guided genicular nerve blocks with 0.5% bupivacaine provide improved knee analgesia for patients recovering from total knee replacement surgery compared to saline injection?
Hypotheses:
The investigators hypothesize that the combination of ultrasound-guided adductor canal block (ACB) and genicular nerve block will achieve lower opioid consumption and therefore lead to decreased systemic side effects and improved overall satisfaction compared to ultrasound-guided saline injection for patients undergoing minimally invasive elective total knee arthroplasty (TKA).
Detailed description
The study medication and protocol will consist of Group 1 (Active) - ultrasound-guided adductor canal blockade with 10 ml of 0.25% bupivacaine and ultrasound-guided genicular nerve blocks with 6 ml of 0.5% bupivacaine, and Group 2 (Control) - ultrasound-guided adductor canal block with 10 ml of 0.25% bupivacaine and ultrasound-guided genicular nerve blocks with 6 ml of normal saline. The surgeon will be blinded to the subjects study arm assignment.
An ultrasound-guided ACB will be performed at the level of the mid-thigh of the leg halfway between the superior anterior iliac spine and the patella. The femoral artery, femoral vein, saphenous nerve will be visualized by ultrasonography and the expansion of the adductor canal will be recorded. Sensory assessment of the saphenous distribution will be performed at 30 minutes. The ultrasound-guided genicular nerve block will be performed at the site of the superior lateral, the superior medial, and the inferior medial genicular nerves. The superior lateral genicular nerve is located at the confluence of the lateral femoral shaft and the lateral femoral condyle (in the anteroposterior plane) and at the midpoint of the femur (in the lateral plane). The superior medial genicular nerve site is located at the confluence of the medial femoral shaft and the medial femoral condyle (in the anteroposterior plane) and at the midpoint of the femur (in the lateral plane). The inferior medial genicular nerve site is located at the confluence of the medial tibial shaft and the tibial flare (in the anteroposterior plane) and the midpoint of the tibia (in the lateral plane). Color Doppler will be used to identify the arterial structures which serve as landmarks for the corresponding nerves. All nerve blocks will be performed by a study team physician.
Postoperative follow-up will be done by study team member blinded to the group allocation. The dosing of oxycodone/hydrocodone-acetaminophen will be as needed with management goal of a Visual Analog Scale (VAS) score of ≤ 4. Patients with pain not managed by oral agents will receive IV medication. Patients will be visited during their hospital stay every six hours until discharge to record pain scores, opioid consumption, and patient satisfaction. In addition, patients will be given a pain diary to record (VAS) pain scores every six hours until hospital discharge.
A study team member will follow up patients by telephone (if discharged prior to) at 48 hours, 72 hours.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: bupivacainePatient will receive genicular nerve block with bupivacaine |
| Group 2 | Placebo comparator | Drug: salinePatient will receive normal saline as the nerve block |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participants 40 to 85 years old who are presenting for minimally invasive total knee arthroplasty under spinal anesthesia and are candidates for peripheral nerve blocks.
- Minimally invasive is defined as custom modified instrumentation, a quadriceps sparing arthrotomy that does not extend beyond 1cm proximal to the patella and surgical techniques that focus on soft tissue protection.
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: BUPIVGroup 1 will receive genicular nerve block using bupivacaine | Drug | Group 1 |
| salineAlso: SALGroup 2 will receive genicular nerve block using normal saline | Drug | Group 2 |
Primary outcome
Post-operative Opioid Consumption During the Hospital Stay
Time frame: 36 hours after surgery
Post-operative opioid consumption measured in morphine milligram equivalents (MME)during the hospital stay up to 36 hours after surgery.
3 secondary outcomes
Mean Pain Scores of the Knee at Rest for the First 48 Hours After Surgery
Time frame: 48 hours after surgery
Overall Satisfaction With Pain Control 72 Hours After Surgery
Time frame: 72 hours after surgery
Length of Hospitalization
Time frame: Admission to discharge from hospital
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
- 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 M 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 saline in people with Postoperative Pain and Total Knee Arthroplasty, 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 2 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: stopped early, as of the sponsor's last update on 28 Sep 2022. 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 28 Sep 2022). 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?
Post-operative Opioid Consumption During the Hospital Stay (time frame: 36 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 28 Sep 2022; AzTrials last refreshed its copy on 27 Oct 2026.