Effectiveness of Thread Embedding Acupuncture Analgesia at the EX-B2 Point Combined With Standard Therapy After Laparoscopic Living Donor Nephrectomy

University of Indonesia (UI)

Status: Completed

Conditions: Quality of Life; Renal Transplant Donor of Left Kidney; Acupuncture Analgesia; Post Operative Pain, Acute

Treatments: Other: Thread embedding acupuncture and standard therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06197620

23-08-1375

Details and patient eligibility

About

Kidney transplantation is the main option besides hemodialysis and continuous ambulatory peritoneal dialysis (CAPD) to prolong and improve the quality of life for patients with end-stage renal disease. The main option for obtaining organs from living donors is surgical action to remove the kidney (nephrectomy) using the laparoscopic method (laparoscopic live donor nephrectomy or LLDN). Postoperative management of LDNH in the form of intravenous paracetamol 1000 mg cannot overcome innovative pain and has drug-related risk effects.

Non-pharmacological pain management is the first line of pain management. One non-pharmacological therapy that can be an option is acupuncture. Thread embedding acupuncture (TEA) is an acupuncture method that uses certain medical threads such as catgut or polydioxanone (PDO) which are inserted into subcutaneous tissue or muscle at certain acupuncture points.

The working mechanism of TEA in treating pain is through local mechanisms in the form of releasing adenosine which binds to adenosine A1 receptors, releasing substance P, inhibiting the expression and activation of Nuclear Factor Kappa B; through a segmental mechanism in the form of a control gate mechanism; through extrasegmental mechanisms in the form of downward pain inhibition pathways; through a central mechanism in the form of release of endogenous opioids in the hypothalamus. ATB can provide a continuous stimulating effect of infiltration and acceleration of tissue regeneration, increasing anti-pain.

Full description

The main outcome is to determine the effect of thread embedding acupuncture at the EX-B2 point on first lumbar on pain intensity in patients after laparoscopic living donor nephrectomy (LLDN) and to determine the effect of thread embedding acupuncture at the EX-B2 point on first lumbar on the quality of life in patients after laparoscopic living donor nephrectomy (LLDN).

The thread embedding will use Polydioxanone thread size 30G x 25,4 mm. This thread will last maximum 7 months before fully absorbed.

Pain intensity will be assessed using the VAS score 7 days before LLDN surgery (before the thread implant acupuncture procedure); and on the first, second, third, and fourteenth days after the LLDN procedure.

Quality of life scores will be measured with the Indonesian version of SF-36 questionnaire carried out seven days before LLDN surgery, on the first postoperative day, and on the fourteenth day after LLDN surgery.

The research design in this study was a case series with 6 subject only.

Enrollment: 6 patients

Sex: All

Ages: 21 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Subjects are prospective kidney donors who will undergo laparoscopic living donor nephrectomy (LLDN).
2. Adult patients with an age range of 21-60 years.
3. Willing to take part in this research and sign informed consent.

Exclusion criteria

1. The patient has a history of hypersensitive reactions to thread embedding acupuncture (TEA).
2. The patient has a history of keloids or is prone to keloid formation.
3. The patient has skin disease at the location of the TEA installation area in the back area.
4. There are abnormalities in the neurological examination of the lower extremities.
5. Have a history of spinal surgery or are scheduled to undergo spinal surgery within 7 months after the LLDN procedure.
6. There is scoliosis based on clinical examination.
7. There are other specific diagnoses that can cause secondary low back pain such as inflammatory spondylitis, spinal infection, or tumor.
8. Female patients who plan to become pregnant within 7 months after the LLDN procedure.
9. The patient has a body mass index (BMI) below 18 kg/m2
10. The patient has uncontrolled diabetes mellitus.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

6 participants in 1 patient group

Thread Embedding Acupuncture and Standard Therapy

Experimental group

Description:

The patients are pre-operative laparoscopic living donor nephrectomy patients that receive standard analgetic drug treatment according to post-operative kidney donor transplant protocol and receive thread embedding acupuncture. All patients are also given standard therapy after surgery in the form of intravenous Paracetamol 1000 mg, 3 times a day.

Treatment:

Other: Thread embedding acupuncture and standard therapy