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Not yet recruiting NCT06783556

The Analgesia Effect of Electroacupuncture Battlefield Acupuncture Versus Sham Electroakupuncture Post Surgery

No phase Interventional Percutaneous Nephrolithotomy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: The Ear Electroacupuncture of Battlefield Acupuncture (BFA) and paracetamol intravenous therapy, The sham electroacupuncture and paracetamol intravenous therapy.
Who it may be relevant to
Registry conditions: Percutaneous Nephrolithotomy. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Indonesia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

The Analgesia Effect of Electroacupuncture of Battlefield Acupuncture (BFA) Versus Sham Electroacupuncture on Pain, Analgesic Dose Reduction and Quality of Life Post Percutaneous Nephrolithotomy Surgery

Overview

The goal of this clinical trial is to learn the effect of ear electroacupuncture BFA therapy in reducing pain, analgesic dose, and improving patient quality of live post percutaneous nephrolithotomy surgery. The main questions it aims to answer are: * Does BFA ear electroacupuncture reduce postoperative pain of percutaneous nephrolithotomy surgery better than sham electroacupuncture group? * Does BFA ear electroacupuncture reduce postoperative analgesic dose of percutaneous nephrolithotomy surgery better than sham electroacupuncture group? * Does BFA ear electroacupuncture improve postoperative quality of life of percutaneous nephrolithotomy surgery better than sham electroacupuncture group? Researchers will compare ear electroacupuncture BFA to sham electroacupuncture to see the different analgesia effect between these groups. Participants will: * Get ear electroacupuncture BFA or sham electroacupuncture therapy, 2 hours before surgery for 30 minutes * Take drug paracetamol 1000 mg intravenous after surgery according to the needs of the patient's pain complaints after surgery in both groups

Interventions

  • Device The Ear Electroacupuncture of Battlefield Acupuncture (BFA) and paracetamol intravenous therapy
    Electroacupuncture therapy was performed 2 hours before PCNL surgery. Needle insertion was performed perpendicularly at the Battlefield Acupuncture (BFA) points of the ear, namely MA-IT1 Cingulate gyrus, MA-AT2 Thalamus, MA-H2 Omega2, MA-H1 Point Zero and MA-TF1 Shenmen bilaterally. Then the electrostimulator cable was connected to the ear acupuncture points MA-AT2 and MA-TF1 bilaterally on the same side and then fixed with plaster. Electroacupuncture uses continuous waves of 2 Hz frequency with
  • Device The sham electroacupuncture and paracetamol intravenous therapy
    Sham electroacupuncture therapy was performed 2 hours before PCNL surgery. Needle only attached using plester (not inserted) at the Battlefield Acupuncture (BFA) points of the ear, namely MA-IT1 Cingulate gyrus, MA-AT2 Thalamus, MA-H2 Omega2, MA-H1 Point Zero and MA-TF1 Shenmen bilaterally. Then the electrostimulator cable was connected to the ear acupuncture points MA-AT2 and MA-TF1 bilaterally on the same side and then fixed with plaster. Electroacupuncture device is not turned on. The therapy

Primary outcome measures

  • Visual Analogue Scale [Time frame: Before therapy, minute 0, hour 8, hour 24, hour 48]
Secondary outcome measures (3)
  • Analgesic dose reduction [Time frame: hour 8, hour 24, hour 48]
  • Short Form 36 (SF-36) Questionnaire [Time frame: Before therapy, day 7]
  • Adverse effects [Time frame: Day 7]

Eligibility criteria

Inclusion criteria

  • Men or women aged 18-65 years
  • Patients who have been diagnosed with kidney stones measuring > 2 cm and will undergo PCNL surgery
  • VAS score <7, assessed 2 hours before PCNL surgery
  • Receive standard analgesic therapy
  • Willing to participate in this study until completion and sign an informed consent.

Exclusion criteria

  • Kidney anatomical abnormalities
  • Ear deformities (microtia)
  • Patients with cognitive impairment, uncooperative (receiving antidepressants or strong opioid or narcotic analgesics)
  • Tumors, wounds or skin infections in the needling area.
  • Heart rhythm disorder, unstable hemodynamics that require intensive care including extremely high body temperature and using a pacemaker.
  • Allergy to acupuncture needles or certain metals
  • Patients who have had a DJ stent or nephrostomy before PCNL
  • History of metal implants in the body except amalgam

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Factorial
Masking
Double blind
Primary purpose
Treatment

Study locations

Indonesia · 1 center
  • Universitas Indonesia — Jakarta Pusat

Identifiers

NCT: NCT06783556 · 24-12-1845

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗