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Analgesic Effect of Peripheral Cutaneous Nerve Block of Knee Joint After Total Knee Arthroplasty

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ClinicalTrials.gov Identifier: NCT05202730
Recruitment Status : Recruiting
First Posted : January 21, 2022
Last Update Posted : January 21, 2022
Sponsor:
Information provided by (Responsible Party):
Diwuweilong, Xijing Hospital

Brief Summary:
Local anesthesia was performed on patients with total knee arthroplasty (TKA) through two different injection sites of local anesthetics and two local anesthetic drug . The pain score of patients after TKA was collected, then the analgesic effect of patients after TKA through two different injection sites and two different local anesthetic drug were analyzed and evaluated.

Condition or disease Intervention/treatment Phase
Arthroplasty, Replacement, Knee Analgesia Procedure: New local anesthesia injection site and new local anesthetic drug formulation. Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Analgesic Effect of Peripheral Cutaneous Nerve Block of Knee Joint After Total Knee Arthroplasty
Actual Study Start Date : December 25, 2021
Estimated Primary Completion Date : December 10, 2022
Estimated Study Completion Date : May 10, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Traditional injection site and traditional local anesthetic formulation Procedure: New local anesthesia injection site and new local anesthetic drug formulation.
The traditional injection site is the posterior joint capsule and the popliteal artery space (iPACK) plus multiple layers of tissues around the knee joint (posterior joint capsule, ligaments and subcutaneous tissue). The traditional local anesthetic formulation is 1% ropivacaine 10ml+ normal saline 40ml+10mg Morphine + 5mg dexamethasone. The new local anesthesia injection site is iPACK+Knee Cutaneous Nerve Block. The new local anesthetic formula is 1% ropivacaine 10ml+ normal saline 40ml+10mg morphine+1ml triamcinolone acetonide.

Experimental: Traditional injection site and new local anesthetic formulation Procedure: New local anesthesia injection site and new local anesthetic drug formulation.
The traditional injection site is the posterior joint capsule and the popliteal artery space (iPACK) plus multiple layers of tissues around the knee joint (posterior joint capsule, ligaments and subcutaneous tissue). The traditional local anesthetic formulation is 1% ropivacaine 10ml+ normal saline 40ml+10mg Morphine + 5mg dexamethasone. The new local anesthesia injection site is iPACK+Knee Cutaneous Nerve Block. The new local anesthetic formula is 1% ropivacaine 10ml+ normal saline 40ml+10mg morphine+1ml triamcinolone acetonide.

Experimental: New injection site and traditional local anesthetic formulation Procedure: New local anesthesia injection site and new local anesthetic drug formulation.
The traditional injection site is the posterior joint capsule and the popliteal artery space (iPACK) plus multiple layers of tissues around the knee joint (posterior joint capsule, ligaments and subcutaneous tissue). The traditional local anesthetic formulation is 1% ropivacaine 10ml+ normal saline 40ml+10mg Morphine + 5mg dexamethasone. The new local anesthesia injection site is iPACK+Knee Cutaneous Nerve Block. The new local anesthetic formula is 1% ropivacaine 10ml+ normal saline 40ml+10mg morphine+1ml triamcinolone acetonide.

Experimental: New injection site and new local anesthetic formulation Procedure: New local anesthesia injection site and new local anesthetic drug formulation.
The traditional injection site is the posterior joint capsule and the popliteal artery space (iPACK) plus multiple layers of tissues around the knee joint (posterior joint capsule, ligaments and subcutaneous tissue). The traditional local anesthetic formulation is 1% ropivacaine 10ml+ normal saline 40ml+10mg Morphine + 5mg dexamethasone. The new local anesthesia injection site is iPACK+Knee Cutaneous Nerve Block. The new local anesthetic formula is 1% ropivacaine 10ml+ normal saline 40ml+10mg morphine+1ml triamcinolone acetonide.




Primary Outcome Measures :
  1. Change of the pain score before and after surgery [ Time Frame: pre-operation, 6hours after surgery, 24hours after surgery, 48 hours after surgery. ]
    A Visual Analogue Scale (VAS) is used to measure the amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain. Using a ruler, the score is determined by measuring the distance (mm) on the 10cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.



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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1. Patients between the ages of 40-75, who meet the indications for total knee arthroplasty(TKA) surgery, plan to undergo unilateral TKA surgery, can tolerate surgical trauma, and have no surgical contraindications;
  • 2. Patients who have good medical obedience and can cooperate to complete the evaluation of various indicators after the operation and continue to receive follow-up;
  • 3. There is no contraindications to combined spinal-epidural anesthesia;
  • 4. Agree to accept this trial and sign an informed consent form.

Exclusion Criteria:

  • 1. Allergic to test drugs;
  • 2. Abnormal liver, kidney or heart function;
  • 3. People who have chronic pain symptoms in other parts of the body other than the knee joint;
  • 4. Patients with a history of multiple operations on the knee joint, or patients with abnormal anatomical structures;
  • 5. Patients who cannot perform early functional exercise after unconventional knee replacement or other systemic diseases;
  • 6. Cannot communicate with researchers normally.

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): NCT05202730


Contacts
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Contact: Weilong Diwu, M.M. +8618792498312 diwuweilong@sohu.com

Locations
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China, Shanxi
Department of Orthopedics, Xijing Hospital, The Air Force Medical University Recruiting
Xi'an, Shanxi, China, 710032
Contact: Weilong Diwu, M.M.    +8618792498312    diwuweilong@sohu.com   
Sponsors and Collaborators
Diwuweilong
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Responsible Party: Diwuweilong, Principal Investigator, Xijing Hospital
ClinicalTrials.gov Identifier: NCT05202730    
Other Study ID Numbers: KY20212115-F-2
First Posted: January 21, 2022    Key Record Dates
Last Update Posted: January 21, 2022
Last Verified: January 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anesthetics
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents