A Phase 4 interventional study of bupivacaine and saline in Postoperative Pain, Total Knee Arthroplasty and Nerve Block, sponsored by Northwestern University. Terminated at 1 site in United States. Open to participants aged 40 Years to 85 Years. Per ClinicalTrials.gov, last updated 2022-09-28.
Sponsored by Northwestern University · Phase 4, Interventional, and Prevention
Among 362 studies testing bupivacaine in Pain, Postoperative — 55 open to participants now, 58 under way, 5 of them phase 3. Bupivacaine · Pain, Postoperative.
Among the 362 studies testing bupivacaine in Pain, Postoperative, this one is the 347th largest by enrollment, is one of 31 that started in 2017, is one of 133 in phase 4, and was the 129th registered.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's enrollment of 2 is below the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →55 of the 362 studies testing bupivacaine in Pain, Postoperative are open now, in 8 countries. Each count lists the studies.
Bupivacaine: first FDA approval 1972 (MARCAINE HYDROCHLORIDE PRESERVATIVE FREE), first EMA approval 2020. What it is approved for, and how studies give it, is on its page →
Of the 679 Pain, Postoperative studies recruiting now, 241 (35%) set no upper age limit and 328 (48%) stop at 75 or younger; 74 take children under 18; 128 take healthy volunteers.
This study: 40 Years to 85 Years · all sexes · no healthy volunteers.
The full table on the hub →362 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 31 started in 2017.
Median enrollment 70 across the 362 interventional studies. Of the 258 that completed or were terminated, 106 (41%) have results posted.
46 of 362 have an industry lead sponsor. The 10 most frequent:
Northwestern University is the lead sponsor of 1,423 studies on the registry; 198 are open to participants now.
Of its 105 completed or terminated interventional studies of FDA-regulated products, 78 (74%) have results posted.
12 studies in Pain, Postoperative by Northwestern University: 4 open now, 4 under way, none of them phase 3. Of 5 finished, 4 (80%) have results posted.
Among the 12 studies in Pain, Postoperative by Northwestern University, this one is the 9th largest by enrollment, is the only one that started in 2017, is one of 6 in phase 4, and was the 6th registered.
Northwestern University’s Pain, Postoperative studies by the year they started, since 2010.
21 of the studies testing bupivacaine in Pain, Postoperative that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06350981Phase 3Foundation for Orthopaedic Research and EducationAnalgesic Requirement for Post-Operative Pain Control in TLIP Interbody Fusion | 2027-01-01 |
| NCT06077422Phase 3Rutgers, The State University of New JerseyExparel vs. Marcaine ESP Block for Post-cardiac Surgical Pain | 2027-01-11 |
| NCT07650760Wah Medical college , POF hospitalComparison of Intraperitoneal Bupivacaine and Saline Irrigation for Pain Relief After Laparoscopic Cholecystectomy | 2026-12 |
| NCT03737292Milton S. Hershey Medical CenterLiposomal Bupivacaine Versus Plain Bupivacaine After Intercostal Injections For Pain Management After Thoracoscopy | 2026-12 |
| NCT02381353Mayo ClinicExparel Injection for Postoperative Orbital Pain | 2026-12 |
Among the 362 studies testing bupivacaine in Pain, Postoperative, from their registry updates:
Among Northwestern University’s 12 in Pain, Postoperative:
Nothing recorded among them since 2026-09-25.
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).
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patient will receive genicular nerve block with bupivacaine
Drug: bupivacaine
Patient will receive normal saline as the nerve block
Drug: saline
Group 1 will receive genicular nerve block using bupivacaine
Also known as: BUPIV
Group 2 will receive genicular nerve block using normal saline
Also known as: SAL
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.
Time frame: 36 hours after surgery
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.
Time frame: 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
Time frame: 72 hours after surgery
Length of Hospitalization
Length of hospitalization in hours from time to admission to time of discharge.
Time frame: Admission to discharge from hospital
| Milestone | Bupivacaine Block | Saline Sham |
|---|---|---|
| Started | 2 | 0 |
| Completed | 2 | 0 |
| Not completed | 0 | 0 |
Post-operative opioid consumption measured in morphine milligram equivalents (MME)during the hospital stay up to 36 hours after surgery.
| Morphine milligram equivalents (MME) | Group 1 | Group 2 |
|---|---|---|
| Post-operative Opioid Consumption During the Hospital Stay | 24.17 (23 to 27.2) | — |
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.
| score on a scale | Group 1 | Group 2 |
|---|---|---|
| Mean Pain Scores of the Knee at Rest for the First 48 Hours After Surgery | 3.05 (2.6 to 3.5) | — |
Overall satisfaction with pain control 72 hours after surgery using a visual analog scale where 0 = not satisfied and 10 being extremely satisfied
| score on a scale | Group 1 | Group 2 |
|---|---|---|
| Overall Satisfaction With Pain Control 72 Hours After Surgery | 7 (6 to 8) | — |
Length of hospitalization in hours from time to admission to time of discharge.
| Elapsed time in hours | Group 1 | Group 2 |
|---|---|---|
| Length of Hospitalization | 38.29 (30.57 to 46) | — |
Collected over 72 hours after surgical procedure.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group 1 | 0/2 (0%) | 0/2 (0%) | 1/2 (50%) |
| Group 2 | — | — | — |
| Event | Group 1 | Group 2 |
|---|---|---|
| NauseaGastrointestinal disorders | 1/2 | — |
Study terminated early due to low enrollment.
| Age, Continuous(Years) | Group 1 | Group 2 | Total |
|---|---|---|---|
| Mean | 71.5 (70 to 73) | — | 71.5 (70 to 73) |
| Sex: Female, Male(Participants) | Group 1 | Group 2 | Total |
|---|---|---|---|
| Female | 2 | — | 2 |
| Male | 0 | — | 0 |
| Race (NIH/OMB)(Participants) | Group 1 | Group 2 | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | — | 0 |
| Asian | 0 | — | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | — | 0 |
| Black or African American | 0 | — | 0 |
| White | 2 | — | 2 |
| More than one race | 0 | — | 0 |
| Unknown or Not Reported | 0 | — | 0 |
| Region of Enrollment(participants) | Group 1 | Group 2 | Total |
|---|---|---|---|
| United States | 2 | — | 2 |
| Kilograms (kG) weight(Kilograms) | Group 1 | Group 2 | Total |
|---|---|---|---|
| Mean | 95.8 (88 to 103.6) | — | 95.8 (88 to 103.6) |
| Height Inches(Inches) | Group 1 | Group 2 | Total |
|---|---|---|---|
| Mean | 66.5 (66 to 67) | — | 66.5 (66 to 67) |
| Pre Surgical Baseline Pain at Rest(Units on a scale) | Group 1 | Group 2 | Total |
|---|---|---|---|
| Mean | 3 (1 to 5) | — | 3 (1 to 5) |
PDFs hosted by the registry, ClinicalTrials.gov.
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Studies of the drug tested here: Bupivacaine