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

NCT06783556 | Not Yet Recruiting

• 1 other identifier: 24-12-1845
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale

  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.

  Before therapy, minute 0, hour 8, hour 24, hour 48

Secondary Outcomes (3)

• Analgesic dose reduction

  hour 8, hour 24, hour 48

• Short Form 36 (SF-36) Questionnaire

  Before therapy, day 7

• Adverse effects

  Day 7

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

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

Control Group

SHAM COMPARATOR

The sham electroacupuncture and paracetamol intravenous therapy

Device: The sham electroacupuncture and paracetamol intravenous therapy

Interventions

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.

Intervention Group

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.

Control Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Universitas Indonesia

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

Study Officials

• KPEK FKUI-RSCM

  The Health Research Ethics Commitee - Faculty of Medicine Universitas Indonesia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hermin Widyaprastuti, MD

CONTACT

+6281286190436; widyaprastuti.hermin1@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The participants, the outcome assessors will be blinded to group allocation
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Model Details: The Ear Electroacupuncture of Battlefield Acupuncture (BFA) and paracetamol intravenous therapy will be designated as the intervention group, while the sham electroacupuncture and paracetamol intravenous therapy will be designated as the control group.

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: January 20, 2025
• Study Start: January 20, 2025
• Primary Completion: April 20, 2025
• Study Completion: June 1, 2025
• Last Updated: January 22, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)