Saphenous Nerve Block Versus Femoral Nerve Block for Total Knee Arthroplasty
| Tracking Information | |||||
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| First Received Date ICMJE | April 8, 2011 | ||||
| Last Updated Date | November 14, 2011 | ||||
| Start Date ICMJE | March 2011 | ||||
| Primary Completion Date | November 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
The primary outcome is the difference between preoperative and postoperative quadriceps muscle strength of both the operative and nonoperative legs, as measured by a handheld dynamometer while patients perform isometric exercises. [ Time Frame: Up to 48 hours following administration of anesthesia. ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Quadriceps strength, as measured by a handheld dynamometer. [ Time Frame: Up to 48 hours following administration of anesthesia. ] [ Designated as safety issue: No ] Primary outcome will be comparing the preoperative and postoperative strengths of the quadriceps muscles of both the operative and nonoperative legs. The strength of the quadriceps will be measured with a handheld dynamometer as patients perform isometric exercises. |
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| Change History | Complete list of historical versions of study NCT01333943 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Saphenous Nerve Block Versus Femoral Nerve Block for Total Knee Arthroplasty | ||||
| Official Title ICMJE | Saphenous (Adductor Canal) Nerve Block Versus Femoral Nerve Block for Total Knee Arthroplasty: A Novel Approach for Postoperative Analgesia | ||||
| Brief Summary | 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Total Knee Arthroplasty | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 73 | ||||
| Completion Date | November 2011 | ||||
| Primary Completion Date | November 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 90 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01333943 | ||||
| Other Study ID Numbers ICMJE | 10146 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | David H. Kim, Hospital for Special Surgery | ||||
| Study Sponsor ICMJE | Hospital for Special Surgery, New York | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Hospital for Special Surgery, New York | ||||
| Verification Date | November 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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