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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02387021
Other study ID # P-2015002/AR
Secondary ID
Status Not yet recruiting
Phase N/A
First received March 4, 2015
Last updated March 7, 2015
Start date March 2015
Est. completion date December 2015

Study information

Verified date March 2015
Source Institut Kassab d'Orthopédie
Contact Karim Raies, M.D
Phone +21655208602
Email karim.raies@gmail.com
Is FDA regulated No
Health authority Tunisia: Ministry of Public Health
Study type Interventional

Clinical Trial Summary

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 .


Recruitment information / eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Continuous femoral nerve block

Continuous adductor canal block

infragluteal Sciatic nerve block

Drug:
Ropivacaine 0.2%

Saline


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Institut Kassab d'Orthopédie

References & Publications (1)

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

Outcome

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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