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

Sponsor
Diwuweilong (Other)
Overall Status
Recruiting
CT.gov ID
NCT05202730
Collaborator
(none)
120
Enrollment
1
Location
4
Arms
16.5
Anticipated Duration (Months)
7.3
Patients Per Site Per Month

Study Details

Study Description

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
  • Procedure: New local anesthesia injection site and new local anesthetic drug formulation.
 N/A

Study Design

Study Type:
Interventional
Anticipated 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 :
Dec 25, 2021
Anticipated Primary Completion Date :
Dec 10, 2022
Anticipated Study Completion Date :
May 10, 2023

Arms and Interventions

Arm Intervention/Treatment
Other: 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.

Outcome Measures

Primary Outcome Measures

  1. Change of the pain score before and after surgery [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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;
    1. 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;
    1. There is no contraindications to combined spinal-epidural anesthesia;
    1. Agree to accept this trial and sign an informed consent form.
Exclusion Criteria:
    1. Allergic to test drugs;
    1. Abnormal liver, kidney or heart function;
    1. People who have chronic pain symptoms in other parts of the body other than the knee joint;
    1. Patients with a history of multiple operations on the knee joint, or patients with abnormal anatomical structures;
    1. Patients who cannot perform early functional exercise after unconventional knee replacement or other systemic diseases;
    1. Cannot communicate with researchers normally.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Orthopedics, Xijing Hospital, The Air Force Medical University Xi'an Shanxi China 710032

Sponsors and Collaborators

  • Diwuweilong

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Diwuweilong, Principal Investigator, Xijing Hospital
ClinicalTrials.gov Identifier:
NCT05202730
Other Study ID Numbers:
  • KY20212115-F-2
First Posted:
Jan 21, 2022
Last Update Posted:
Jan 21, 2022
Last Verified:
Jan 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Anesthetics
Anesthetics, Local

Study Results

No Results Posted as of Jan 21, 2022