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A Randomized Double-Blinded and Placebo-Controlled Trial to Assess the Efficacy of Biophoton Therapy to Treat Type 2 Diabetes

A Randomized Double-Blinded and Placebo-Controlled Trial to Assess the Efficacy of Biophoton Therapy to Treat Type 2 Diabetes

Recruiting
18-70 years
All
Phase N/A

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Overview

This prospective, randomized, double-blind study evaluates the analgesic effectiveness of the ultrasound-guided Quadro-Iliac Plane (QIP) block in patients undergoing primary total hip arthroplasty. The QIP block is a recently described fascial plane block. Patients will be randomized to receive either a QIP block with local anesthetic or a sham block with saline. The primary outcome is 24-hour opioid consumption. Secondary outcomes include motor block, dermatomal sensory assessment, pain scores, rescue analgesic requirement, quality of recovery (QoR-15), and opioid-related side effects.

Description

Total hip arthroplasty is associated with significant postoperative pain. The Quadro-Iliac Plane (QIP) block is a recently described fascial plane block targeting the area where the quadratus lumborum muscle attaches to the iliac crest and may provide more comprehensive analgesia. This study is designed as a prospective, randomized, double-blind clinical trial including patients aged 18-80 years with ASA physical status I-III undergoing elective primary total hip arthroplasty.

Patients will be randomized into two groups. The QIP group will receive an ultrasound-guided QIP block with 40 mL of 0.25% local anesthetic solution containing epinephrine, and the control group will receive a sham block with 40 mL of 0.9% NaCl using the same technique. The primary outcome is postoperative 24-hour opioid consumption. Secondary outcomes include motor block, and dermatomal sensory assessment, pain scores, quality of recovery (QoR-15), rescue analgesic requirement and opioid-related side effects

Eligibility

Inclusion Criteria:

  • Willing and able to give informed consent for participation in the trial.
  • Is able and willing to comply with all trial requirements.
  • Male or female aged 18-70 years old without major diseases.
  • An adult clinically diagnosed with DM2
  • Participants must not be heavy users of Tesla BioHealing devices; enrollment will be determined by the clinical team based on an evaluation of the participant's prior device usage.
  • Must be fluent in English.

Exclusion Criteria:

  • Untreated psychiatric disturbances that would affect trial participation as judged by research medical professionals.
  • Is participating in another investigational drug or device trial

Study details
    Type 2 Diabetes

NCT07124208

First Institute of All Medicines

13 May 2026

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FAQs

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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