A Phase 4 interventional study of Bupivacaine and Preservative free normal saline in Rupture of Anterior Cruciate Ligament, sponsored by Northwestern University. Terminated at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-04-19.
Sponsored by Northwestern University · Phase 4, Interventional, and Prevention
Outpatients scheduled to have ACL surgery typically receive a femoral nerve block to provide analgesia for the front of the knee. Postoperatively, these patients will often report pain in the back of the knee. Local anesthetic infiltration of the posterior aspect of the knee results in blockade of the genicular nerves of the posterior knee. These nerves originate off of the tibial and common peroneal nerves and their blockade will result in improved posterior knee pain relief and may decrease narcotic consumption compared to patients who receive the same infiltration with normal saline.
Femoral nerve blocks are commonly used to provide postoperative analgesia for ACL surgery. The limitation of these blocks is the incomplete analgesia they provide of the knee joint subjecting the patient to posterior knee pain. As a result, some of these patients receive rescue sciatic blocks in the postoperative care unit to cover posterior knee pain. The sciatic block provides excellent analgesia for the posterior knee; however its blockade invariably affects other territories of the sciatic nerve such as the lower leg and foot. For ACL surgery, the loss of sensation and/or motor strength to this area is unnecessary and may make ambulation more difficult. The ability to ambulate with minimal assistance may be more important for a patient undergoing an outpatient surgery when compared to an inpatient surgery.
At the posterior knee, the sciatic nerve branches off into the tibial and common peroneal nerves which give rise to sensory fibers that innervate the posterior knee. We propose targeting these terminal fibers in the popliteal fossa by infiltrating local anesthetic between the distal femoral shaft and popliteal artery thereby providing posterior knee analgesia without affecting the lower leg.This application of this block has not been studied in patients having ACL surgery. A single interim analysis is scheduled after the data for 50 cases are available.
557 studies on the registry are indexed under Rupture; 97 are open to participants now.
This study's enrollment of 18 is below the median of 72 across 334 interventional studies indexed under Rupture.
Browse Rupture studies →Northwestern University is the lead sponsor of 1,396 studies on the registry; 199 are open to participants now.
Of its 102 completed or terminated interventional studies of FDA-regulated products, 73 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Ultrasound guided posterior genicular nerve infiltration with 30mL of Bupivicaine 0.20% with epinephrine 1:300,000 (Study Drug)
Drug: Bupivacaine
Ultrasound guided posterior genicular nerve infiltration posterior knee with 30mL of preservative free normal saline
Drug: Preservative free normal saline
30mL of Bupivicaine 0.20% with epinephrine 1:300,000
Also known as: Marcaine
Ultrasound guided posterior genicular nerve infiltration posterior knee with 30mL of preservative free normal saline
Also known as: 0.9% sodium chloride
Opioid Consumption
Opioid consumption (mg morphine equivalents)
Time frame: 24 hours
Pain Score
Numeric Rating Scale (NRS) (NRS pain scores; 0 = no pain,10 = excruciating pain) in the back of the knee recorded every 4 hours up to 24hrs following surgery. Pain Bruden scale ranges from 0 (no pain) to 240 (extreme pain). For example, pain burden of 120 is equivalent to a NRS score of 5 out of 10.
Time frame: Pain Burden at 24hrs
Patient Satisfaction
Patient satisfaction with pain control scale ranges from 0 (no satisfaction) to 10 (very satisfied).
Time frame: 24hr
Quality of Recovery (QoR15)
Quality of recovery (QoR15) is a questionnaire that asks 15 questions regarding how the participant has felt in the last 24 hours. Each question is followed by an 11-point numerical rating scale (0 = "none of the time" to 10 = "all of the time"; maximum score 150). The higher the QoR15 total score, the worse the quality of recovery reported.
Time frame: 24hrs
| Milestone | Study Drug | Preservative Free Normal Saline |
|---|---|---|
| Started | 8 | 10 |
| Completed | 8 | 10 |
| Not completed | 0 | 0 |
Opioid consumption (mg morphine equivalents)
| mg morphine equivalents | Study Drug | Preservative Free Normal Saline |
|---|---|---|
| Opioid Consumption | 50 (40 to 70) | 70 (50 to 80) |
Numeric Rating Scale (NRS) (NRS pain scores; 0 = no pain,10 = excruciating pain) in the back of the knee recorded every 4 hours up to 24hrs following surgery. Pain Bruden scale ranges from 0 (no pain) to 240 (extreme pain). For example, pain burden of 120 is equivalent to a NRS score of 5 out of 10.
| units on a scale | Study Drug | Preservative Free Normal Saline |
|---|---|---|
| Pain Score at Rest | 102 (58 to 160) | 135 (112 to 146) |
| Pain Score during plantar flexion | 115 (50 to 182) | 128 (96 to 144) |
Patient satisfaction with pain control scale ranges from 0 (no satisfaction) to 10 (very satisfied).
| units on a scale | Study Drug | Preservative Free Normal Saline |
|---|---|---|
| Patient Satisfaction | 8 (7 to 8) | 8 (6 to 10) |
Quality of recovery (QoR15) is a questionnaire that asks 15 questions regarding how the participant has felt in the last 24 hours. Each question is followed by an 11-point numerical rating scale (0 = "none of the time" to 10 = "all of the time"; maximum score 150). The higher the QoR15 total score, the worse the quality of recovery reported.
| units on a scale | Study Drug | Preservative Free Normal Saline |
|---|---|---|
| Quality of Recovery (QoR15) | 96 (84 to 110) | 102 (80 to 114) |
Collected over 24hr following surgery.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Study Drug | — | 0/8 (0%) | 0/8 (0%) |
| Preservative Free Normal Saline | — | 0/10 (0%) | 0/8 (0%) |
| Age, Continuous(years) | Study Drug | Preservative Free Normal Saline | Total |
|---|---|---|---|
| Median | 25 (24 to 32) | 29 (23 to 38) | 27 (23 to 34) |
| Sex: Female, Male(Participants) | Study Drug | Preservative Free Normal Saline | Total |
|---|---|---|---|
| Female | 4 | 6 | 10 |
| Male | 4 | 4 | 8 |
| Region of Enrollment(participants) | Study Drug | Preservative Free Normal Saline | Total |
|---|---|---|---|
| United States | 8 | 10 | 18 |
Plan to share: No
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