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NCT Number: NCT06783556

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

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

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Key information

Conditions

Percutaneous Nephrolithotomy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

The Ear Electroacupuncture of Battlefield Acupuncture (BFA) and paracetamol intravenous therapy

Device

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 an intensity that can be tolerated by the patient for 30 minutes.

Patients also received standard therapy with 1000 mg intravenous paracetamol with a maximum of 3 times administration per 24 hours and can be reduced according to the needs of the patient's pain complaints.

The sham electroacupuncture and paracetamol intravenous therapy

Device

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 is carried out for 30 minutes.

Patients also received standard therapy with 1000 mg intravenous paracetamol with a maximum of 3 times administration per 24 hours and can be reduced according to the needs of the patient's pain complaints.

Primary outcomes

  1. Visual Analogue Scale

    Time frame: Before therapy, minute 0, hour 8, hour 24, hour 48

    Visual Analogue Scale is the tool that measures pain intensity. It use a scale with a minimum range of 0 and a maximum of 10, where 0 indicates no pain and 10 indicates the worst pain. Higher scores indicate worse pain.

Secondary outcomes

  1. Analgesic dose reduction

    Time frame: hour 8, hour 24, hour 48

    Paracetamol 1000 mg IV is given to patient with a maximum of 3 times administration per 24 hours. The dose of paracetamol can be reduced when the patien's pain score of Visual Analogue Score is less than 3. Measurements were made by measuring the cumulative dose of analgesics after acupuncture therapy. Then compared between the two groups, which group had a greater decrease in analgesic dose.

  2. Short Form 36 (SF-36) Questionnaire

    Time frame: Before therapy, day 7

    The SF-36 questionnaire consists of eight scales yielding two summary measures: physical and mental health. The physical health measure includes four scales of physical functioning (10 items), role-physical (4 items), bodily pain (2 items), and general health (5 items). The mental health measure is composed of vitality (4 items), social functioning (2 items), role-emotional (3 items), and mental health (5 items). To score the SF-36, scales are standardized with a scoring algorithm to obtain a score ranging from 0 to 100. Higher scores indicate better health status.

  3. Adverse effects

    Time frame: Day 7

    Record the adverse effects that occur after acupuncture therapy. It will be monitored for 7 days after therapy and recorded on the 7th day by assessor.

Study contacts

Contact information is provided by the study sponsor or research team.

Hermin Widyaprastuti, MD

CONTACT

[email protected]

+6281286190436

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 20, 2025
Registry last updated
Jan 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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