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

NCT ID: NCT06783556

Last Updated: 2025-01-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-20
• Study Completion Date: 2025-06-01

Brief Summary

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

Conditions

Percutaneous Nephrolithotomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Intervention Group

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Control Group

The sham electroacupuncture and paracetamol intravenous therapy

Group Type: SHAM_COMPARATOR

The sham electroacupuncture and paracetamol intravenous therapy

Intervention Type: 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.

Interventions

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 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.

Intervention Type: 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 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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indonesia University

OTHER

Sponsor Role: lead

Responsible Party

Hermin Widyaprastuti

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

KPEK FKUI-RSCM

Role: PRINCIPAL_INVESTIGATOR

The Health Research Ethics Commitee - Faculty of Medicine Universitas Indonesia

Locations

Universitas Indonesia

Jakarta Pusat, DKI Jakarta, Indonesia

Countries

Indonesia

Central Contacts

Hermin Widyaprastuti, MD

Role: CONTACT

widyaprastuti.hermin1@gmail.com

+6281286190436

Facility Contacts

Hermin Widyaprastuti

Role: primary

hermin.widyaprastuti1@gmail.com

+6281286190436

Other Identifiers

24-12-1845

Identifier Type: -

Identifier Source: org_study_id