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Adductor Canal Mid-thigh and Adductor Canal Distal Thigh: Is Cutaneous Sensory Blockade Similar Among Block Techniques?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02788019
Recruitment Status : Terminated (Unable to complete the sample size needed for 80% power due to changes in surgical approach to adductor block usage.)
First Posted : June 2, 2016
Last Update Posted : May 14, 2020
Sponsor:
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

Brief Summary:
This is a randomized noninferiority interventional study to determine the equivalence of two adductor canal block (ACB) methods: mid-thigh and distal thigh in patients undergoing medial foot, medial ankle, or medial leg surgery. Sixty eight patients will be identified during their orthopedic presurgical clinic visit, anesthesia preoperative clinic visit or Day Surgery Unit (Zale Lipshy Hospital, Clements University Hospital, and UTSW Outpatient Surgery Center) for eligibility. Eligible individuals may be introduced to the study in the orthopedic presurgical clinic or the anesthesia preoperative clinic by staff. After consent patients will be randomized (break-seal method) to receive either a mid-thigh or distal thigh block using ropivacaine prior to foot, ankle, or leg surgery. The following measurements will be obtained to determine the change in sensory distribution: pinprick test with Neuropen, maximum voluntary isometric contraction before and after block, postoperative pain scores (24 hrs and at discharge) and postoperative opiate consumption.

Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Ropivacaine Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Adductor Canal Mid-thigh and Adductor Canal Distal Thigh: Is Cutaneous Sensory Blockade Similar Among Block Techniques?
Actual Study Start Date : January 11, 2016
Actual Primary Completion Date : March 23, 2020
Actual Study Completion Date : March 23, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Mid-Thigh Adductor Block
Subject will receive a mid-thigh adductor block method using ropivacaine (0.5%, 15 mL).
Drug: Ropivacaine
Ropivacaine is routinely used to perform localized blockade prior to surgery to improve management of postoperative pain.

Active Comparator: Distal-Thigh Adductor Block
Subject will receive a distal-thigh adductor block method using ropivacaine (0.5%, 15 mL).
Drug: Ropivacaine
Ropivacaine is routinely used to perform localized blockade prior to surgery to improve management of postoperative pain.




Primary Outcome Measures :
  1. Distribution of cutaneous sensation to pinprick after blockade [ Time Frame: 20 minutes ]
    Use of Neuropen to determine distribution of cutaneous sensation


Secondary Outcome Measures :
  1. Post-operative Pain score [ Time Frame: 24 hrs postop ]
    Post-operative pain score will be measured using a VAS pain scale



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adults aged 18 years or older
  • Individuals undergoing surgery of the medial foot, medial ankle, or medial leg for which the anesthetic plan includes an adductor canal nerve block

Exclusion Criteria:

  1. Any known deficit of the ipsilateral lumbar nerve roots, ipsilateral lumbar plexus, ipsilateral femoral nerve, obturator nerve or saphenous nerve including diabetic peripheral neuropathy
  2. Any local disorder of the skin or otherwise where blockade is to be performed
  3. Body mass index >50
  4. ASA classification greater than 3
  5. Allergy to amide local anesthetic medications
  6. Pregnancy
  7. Incarceration
  8. Inability to understand study procedures including inability to understand the English language

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02788019


Locations
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United States, Texas
Zale Lipshy University Hospital
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
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Principal Investigator: Anthony Machi, MD UT Southwestern Medical Center
Publications of Results:

Other Publications:
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Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT02788019    
Other Study ID Numbers: STU 092015-065
First Posted: June 2, 2016    Key Record Dates
Last Update Posted: May 14, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Texas Southwestern Medical Center:
Adductor canal block, nerve block
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents