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Not Yet RecruitingNCT06783556

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

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

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
30 (estimated)
Sponsor
Indonesia University · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DEVICEThe Ear Electroacupuncture of Battlefield Acupuncture (BFA) and paracetamol intravenous therapyElectroacupuncture 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.
DEVICEThe sham electroacupuncture and paracetamol intravenous therapySham 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.

Timeline

Start date
2025-01-20
Primary completion
2025-04-20
Completion
2025-06-01
First posted
2025-01-20
Last updated
2025-01-22

Locations

1 site across 1 country: Indonesia

Source: ClinicalTrials.gov record NCT06783556. Inclusion in this directory is not an endorsement.