Neuromuscular Blockade Clinical Trial
Official title:
Prospective Comparison Between Continuous Femoral Nerve Block and the Association of Adductor Canal Block and Sciatic Nerve Block in Total Knee Arthroplasty.
The purpose of the study is to determine whether the association of sciatic nerve block to continuous adductor canal block is effective in the treatment of total knee arthroplasty post operative pain .
Status | Not yet recruiting |
Enrollment | 80 |
Est. completion date | December 2015 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 90 Years |
Eligibility |
Inclusion Criteria: - Elective unilateral TKA, - Planned continuous spinal anesthesia , - Ability to follow study protocol, - American Society of Anesthesiologists class 1 to 3. Exclusion Criteria: - Contraindication for neuraxial anesthetic, - Chronic opioid use (defined as daily or almost daily use of opioids for >3 months), - Hypersensitivity and/or allergies to any of the study medications, - Intraoperative use of volatile anesthetics, - Preexisting neuropathy on the operative limb, - Contraindications to a femoral, adductor canal or Tibial nerve block. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Institut Kassab d'Orthopédie |
Kim DH, Lin Y, Goytizolo EA, Kahn RL, Maalouf DB, Manohar A, Patt ML, Goon AK, Lee YY, Ma Y, Yadeau JT. Adductor canal block versus femoral nerve block for total knee arthroplasty: a prospective, randomized, controlled trial. Anesthesiology. 2014 Mar;120(3):540-50. doi: 10.1097/ALN.0000000000000119. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total Opioid-consumption | Cumulative opioid consumption : converting oral, intravenous, and patient-controlled analgesia PCA opioid to morphine equivalent | 8 hours postoperative | No |
Secondary | NRS pain score at rest | NRS pain scores determined by patient interview, using the standard NRS of 0 to 10 scale at rest. | 0,1,2,4,6,8,12,24 and 48 hours postoperative | No |
Secondary | NRS pain score during movement | NRS pain scores determined by patient interview, using the standard NRS of 0 to 10 scale, during physiotherapy. | 0,1,2,4,6,8,12,24 and 48 hours postoperative | No |
Secondary | NRS pain score after 10 meters of walk or maximum walked distance | NRS pain scores determined by patient interview, using the standard NRS of 0 to 10 scale after 10 meters walk (if enable after maximum walked distance). | 8, 24 and 48 hours postoperative | No |
Secondary | Ability to walk | The ability of the patient to stand up and walk 3 meters. | 8, 24 and 48 hours postoperative | No |
Secondary | TUG Test | The TUG test measures the time it takes a patient to stand up from a chair, walk a distance of 3 m, and return to the chair | 8, 24 and 48 hours postoperative | No |
Secondary | The 10-m walk test | time it takes the patient to walk a distance of 10 m as quickly as possible | 8, 24 and 48 hours postoperative | No |
Secondary | patient satisfaction | patient interviewed, using a scale of 0-10, 0 not satisfied and 10 being the most satisfied | 8, 24 and 48 hours postoperative | No |
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