Status unknownNCT05202730Updated Mar 6, 2023

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

An interventional study of New local anesthesia injection site and new local anesthetic drug formulation. in Arthroplasty, Replacement, Knee and Analgesia, sponsored by Diwuweilong. Status unknown at 1 site in China. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-03-06.

Sponsored by Diwuweilong · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Mar 2023), so the status shown — last known as Recruiting — may be out of date.

Phase: Not applicable
Study type: Interventional
Enrollment: 120
Allocation: Randomized
Ages: 40 Years to 75 Years
Sex: All

Study 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.

Conditions studied

Arthroplasty, Replacement, Knee
Analgesia

In context

Lead sponsor

This is the only study on the registry with Diwuweilong as lead sponsor.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 40 Years to 75 Years
Sexes eligible: 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

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.

Study design

Phase: Not applicable
Primary purpose: Supportive care
Allocation: Randomized
Intervention model: Factorial assignment
Masking: Double (Participant, Outcomes assessor)
Enrollment: 120 participants (estimated)

Study arms

Other
Traditional injection site and traditional local anesthetic formulation
Procedure: New local anesthesia injection site and new local anesthetic drug formulation.
Experimental
Traditional injection site and new local anesthetic formulation
Procedure: New local anesthesia injection site and new local anesthetic drug formulation.
Experimental
New injection site and traditional local anesthetic formulation
Procedure: New local anesthesia injection site and new local anesthetic drug formulation.
Experimental
New injection site and new local anesthetic formulation
Procedure: New local anesthesia injection site and new local anesthetic drug formulation.

Interventions

ProcedureNew 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.

What researchers measure

Primary outcomes

Change of the pain score before and 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.
Time frame: pre-operation, 6hours after surgery, 24hours after surgery, 48 hours after surgery.

Study locations

1 of 1 sites recruiting

Department of Orthopedics, Xijing Hospital, The Air Force Medical University
Xi'an, Shanxi 710032, China
- Weilong Diwu, M.M. · Contact · diwuweilong@sohu.com · +8618792498312
Recruiting

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 6, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05202730
Lead sponsor: Diwuweilong
Responsible party: Diwuweilong (Principal Investigator, Xijing Hospital) — Sponsor-investigator
First posted: Jan 21, 2022
Start date: Dec 25, 2021
Primary completion: Jul 31, 2023 (estimated)
Completion: Dec 10, 2023 (estimated)
Last update: Mar 6, 2023

Study contacts

Weilong Diwu, M.M.

Contact

diwuweilong@sohu.com

+8618792498312

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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