Clinical trial NCT06783556: The Analgesia Effect of Electroacupuncture Battlefield Acupuncture Versus Sham Electroakupuncture Post Surgery
Official 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Percutaneous Nephrolithotomy
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2025-01-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 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.
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: Before therapy, minute 0, hour 8, hour 24, hour 48
Secondary outcomes:
measure: Analgesic dose reduction
timeFrame: hour 8, hour 24, hour 48
measure: Short Form 36 (SF-36) Questionnaire
timeFrame: Before therapy, day 7
measure: Adverse effects
timeFrame: Day 7
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Universitas Indonesia
state: Dki Jakarta
Study officials:
affiliation: The Health Research Ethics Commitee - Faculty of Medicine Universitas Indonesia
name: KPEK FKUI-RSCM
role: PRINCIPAL_INVESTIGATOR
References: