Saphenous Nerve Block Versus Femoral Nerve Block for Total Knee Arthroplasty
|ClinicalTrials.gov Identifier: NCT01333943|
Recruitment Status : Completed
First Posted : April 12, 2011
Results First Posted : December 18, 2017
Last Update Posted : December 18, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Total Knee Arthroplasty||Procedure: Study Group: Experimental Procedure: Control Group||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||94 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Saphenous (Adductor Canal) Nerve Block Versus Femoral Nerve Block for Total Knee Arthroplasty: A Novel Approach for Postoperative Analgesia|
|Study Start Date :||March 2011|
|Actual Primary Completion Date :||November 2011|
|Actual Study Completion Date :||November 2011|
Saphenous (Adductor Canal) Nerve Block
Procedure: Study Group: Experimental
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).
Other Name: Saphenous (Adductor Canal) Nerve Block
Active Comparator: Control
Femoral Nerve Block
Procedure: Control Group
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).
Other Name: Femoral Nerve Block
- Quadriceps Muscle Strength [ Time Frame: 48 hours following administration of anesthesia. ]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.
- Total Opioid Usage [ Time Frame: Postoperative day 4. ]Opioid consumption data were collected and converted to oral morphine equivalents.
- NRS Pain Scores at Rest [ Time Frame: Postoperative day 4. ]Patients rated pain on a scale of 0-10, with 0 representing no pain and 10 representing worst pain.
- Patient Satisfaction With the Nerve Block. [ Time Frame: 24 hours following administration of anesthesia. ]Patient satisfaction was measured on a 0-10 scale (0=not satisfied; 10=very satisfied).
- Incidence of Postoperative Complications. [ Time Frame: Postoperative day 4. ]
- Total Length of Hospital Stay [ Time Frame: Total length of hospital stay ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01333943
|United States, New York|
|Hospital for Special Surgery|
|New York, New York, United States, 10021|
|Principal Investigator:||David H. Kim, MD||Hospital for Special Surgery, New York|