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

NCT ID: NCT05202730

Last Updated: 2023-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-25

Study Completion Date

2023-12-10

Brief Summary

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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.

Detailed Description

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Conditions

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Arthroplasty, Replacement, Knee Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Traditional injection site and traditional local anesthetic formulation

Group Type OTHER

New local anesthesia injection site and new local anesthetic drug formulation.

Intervention Type PROCEDURE

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.

Traditional injection site and new local anesthetic formulation

Group Type EXPERIMENTAL

New local anesthesia injection site and new local anesthetic drug formulation.

Intervention Type PROCEDURE

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.

New injection site and traditional local anesthetic formulation

Group Type EXPERIMENTAL

New local anesthesia injection site and new local anesthetic drug formulation.

Intervention Type PROCEDURE

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.

New injection site and new local anesthetic formulation

Group Type EXPERIMENTAL

New local anesthesia injection site and new local anesthetic drug formulation.

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Diwuweilong

OTHER

Sponsor Role lead

Responsible Party

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Diwuweilong

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Department of Orthopedics, Xijing Hospital, The Air Force Medical University

Xi’an, Shanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Weilong Diwu, M.M.

Role: CONTACT

+8618792498312

Facility Contacts

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Weilong Diwu, M.M.

Role: primary

+8618792498312

References

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Diwu W, Tang W, Yan M, Ma W, Xu H, Sun Q, Han Y, Wang Y, Wang C, Zhang D, Bi L, Yang M. Efficacy of Peripheral Cutaneous Nerve (PCN) on postoperative pain and functional outcome after total knee arthroplasty: a single-blind, randomized controlled clinical trial". BMC Anesthesiol. 2025 Jul 1;25(1):322. doi: 10.1186/s12871-025-03182-z.

Reference Type DERIVED
PMID: 40597686 (View on PubMed)

Other Identifiers

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KY20212115-F-2

Identifier Type: -

Identifier Source: org_study_id

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