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

University of Indonesia (UI)

Status: Not yet enrolling

Conditions: Percutaneous Nephrolithotomy

Treatments: Device: The sham electroacupuncture and paracetamol intravenous therapy; Device: The Ear Electroacupuncture of Battlefield Acupuncture (BFA) and paracetamol intravenous therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06783556

24-12-1845

Details and patient eligibility

About

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

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

---

30 participants in 2 patient groups

Intervention Group

Experimental group

Description:

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

Treatment:

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

Control Group

Sham Comparator group

Description:

The sham electroacupuncture and paracetamol intravenous therapy

Treatment:

Device: The sham electroacupuncture and paracetamol intravenous therapy