An interventional study of Study Group: Experimental and Control Group in Total Knee Arthroplasty, sponsored by Hospital for Special Surgery, New York. Completed at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2022-05-11.
Sponsored by Hospital for Special Surgery, New York · Not applicable, Interventional, and Treatment
Currently, the regional anesthetic standard of care for total knee replacement surgery is combined spinal/epidural, with or without a femoral nerve block, or FNB. Lasting approximately 18 hours, the FNB works by numbing the femoral nerve (and its branches), which is the major nerve controlling the knee joint. The femoral nerve also provides movement and sensation. While this regional anesthetic technique offers significant postoperative pain relief, it is possible that it may cause muscle weakness and increase patients' recovery time. Hence there is a need for an alternative technique, one that may help minimize postoperative pain as effectively as the FNB, while not causing weakness of the quadriceps muscle.
The saphenous nerve, a branch of the femoral nerve, provides sensation to the knee. Thus it is hypothesized that by "blocking" or anesthetizing the saphenous nerve with local anesthetic closer to where it branches off, the area around and below the knee will feel numb. Yet unlike with the FNB, the quadriceps muscle itself will still be able to function.
Patients will be randomized to receive FNB or saphenous nerve block. Quadriceps strength will be tested using a dynamometer before surgery (baseline), 6-8 hours following anesthesia administration, and on postoperative days 1 and 2. It is hypothesized that patients who receive FNB will experience a 50% decrease in quadriceps strength compared to baseline.
Hospital for Special Surgery, New York is the lead sponsor of 217 studies on the registry; 39 are open to participants now.
Of its 27 completed or terminated interventional studies of FDA-regulated products, 20 (74%) have results posted.
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Exclusion Criteria:
Saphenous (Adductor Canal) Nerve Block
Procedure: Study Group: Experimental
Femoral Nerve Block
Procedure: Control Group
The study group will receive the saphenous nerve block, at the level of the adductor canal. The block will be under ultrasound guidance. The local anesthetic will be 15 ml of 0.5% bupivicaine. The study group will also receive a combined spinal epidural, with 2.5 ml of 0.5% bupivacaine as the spinal agent. Additional drugs include anti-emetics, specifically Ondansetron (4 mg).
Also known as: Saphenous (Adductor Canal) Nerve Block
The control group will receive the femoral nerve block. The block will be under ultrasound guidance. The local anesthetic will be 30 ml of 0.25% bupivicaine. The control group will also receive a combined spinal epidural, with 2.5 ml of 0.5% bupivacaine as the spinal agent. Additional drugs include anti-emetics, specifically Ondansetron (4 mg).
Also known as: Femoral Nerve Block
Quadriceps Muscle Strength
Measurements were made by a handheld dynamometer while patients perform isometric exercises. Results are presented in kilogram-force (kgF) units. One kgF is equal to 9.80665 N.
Time frame: 48 hours following administration of anesthesia.
Total Opioid Usage
Opioid consumption data were collected and converted to oral morphine equivalents.
Time frame: Postoperative day 4.
NRS Pain Scores at Rest
Patients rated pain on a scale of 0-10, with 0 representing no pain and 10 representing worst pain.
Time frame: Postoperative day 4.
Patient Satisfaction With the Nerve Block.
Patient satisfaction was measured on a 0-10 scale (0=not satisfied; 10=very satisfied).
Time frame: 24 hours following administration of anesthesia.
Incidence of Postoperative Complications.
Time frame: Postoperative day 4.
Total Length of Hospital Stay
Time frame: Total length of hospital stay
| Milestone | Experimental | Control |
|---|---|---|
| Started | 47 | 47 |
| Completed | 46 | 47 |
| Not completed | 1 | 0 |
| Withdrew: Known neuropathy | 1 | 0 |
Measurements were made by a handheld dynamometer while patients perform isometric exercises. Results are presented in kilogram-force (kgF) units. One kgF is equal to 9.80665 N.
| kilogram-force | Experimental | Control |
|---|---|---|
| Quadriceps Muscle Strength | 7.3 ± 5.4 | 2.2 ± 3.8 |
Opioid consumption data were collected and converted to oral morphine equivalents.
| mg | Experimental | Control |
|---|---|---|
| Total Opioid Usage | 36.6 ± 17.9 | 35.8 ± 20.7 |
Patients rated pain on a scale of 0-10, with 0 representing no pain and 10 representing worst pain.
| units on a scale | Experimental | Control |
|---|---|---|
| NRS Pain Scores at Rest | 1.7 ± 1.9 | 0.9 ± 1.8 |
Patient satisfaction was measured on a 0-10 scale (0=not satisfied; 10=very satisfied).
| units on a scale | Experimental | Control |
|---|---|---|
| Patient Satisfaction With the Nerve Block. | 8.8 ± 1.9 | 9.1 ± 1.7 |
| Participants | Experimental | Control |
|---|---|---|
| Incidence of Postoperative Complications. | 0 | 0 |
| days | Experimental | Control |
|---|---|---|
| Total Length of Hospital Stay | 3.7 ± 0.8 | 3.6 ± 0.8 |
Collected over 4 days after surgery. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Experimental | 0/47 (0%) | 0/47 (0%) | 0/47 (0%) |
| Control | 0/47 (0%) | 0/47 (0%) | 0/47 (0%) |
| Age, Continuous(years) | Experimental | Control | Total |
|---|---|---|---|
| Mean | 68.0 ± 9.4 | 67.6 ± 11.3 | 67.8 ± 10.4 |
| Sex: Female, Male(Participants) | Experimental | Control | Total |
|---|---|---|---|
| Female | 24 | 29 | 53 |
| Male | 22 | 18 | 40 |
| Region of Enrollment(participants) | Experimental | Control | Total |
|---|---|---|---|
| United States | 46 | 47 | 93 |
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Hospital for Special Surgery, New York