Kidney Transplant; Complications, Postoperative Pain
Conditions
Brief summary
This randomized, double-blind controlled study aims to evaluate the effectiveness of thread implantation acupuncture at EX-B2 L1 in reducing postoperative pain and improving quality of life in patients undergoing laparoscopic living donor nephrectomy. Thirty-four participants will be randomly assigned to receive either thread implantation acupuncture with polydioxanone (PDO) thread at EX-B2 L1 plus standard postoperative therapy or sham thread implantation acupuncture without thread insertion plus the same standard therapy. Pain intensity will be assessed using the Visual Analogue Scale (VAS) and quality of life with the Short-Form 36 (SF-36). The study seeks to determine whether thread implantation acupuncture provides additional analgesic and quality-of-life benefits beyond standard postoperative care.
Detailed description
Laparoscopic donor nephrectomy is the preferred technique for kidney donation due to its minimally invasive nature and faster recovery. However, postoperative pain and decreased quality of life remain significant issues. Excessive reliance on pharmacological analgesia can lead to adverse effects such as hepatotoxicity and gastrointestinal symptoms. Thread implantation acupuncture involves inserting a biodegradable polydioxanone (PDO) thread into acupuncture points to provide prolonged stimulation. The EX-B2 (L1) point has been shown to modulate lumbar innervation and may help reduce nociceptive signaling associated with postoperative pain. This double-blind randomized controlled trial compares the analgesic and quality-of-life outcomes between patients receiving thread implantation acupuncture at EX-B2 (L1) plus standard therapy and those receiving sham thread implantation acupuncture plus standard therapy. Pain intensity (VAS) will be measured pre-intervention (Day 0), then at postoperative Days 1, 2, 3, and 14. Quality of life (SF-36) will be evaluated at Day 0 and Day 14. The results are expected to strengthen evidence for thread implantation acupuncture as an adjunctive therapy for acute postoperative pain management and recovery after laparoscopic donor nephrectomy.
Interventions
DEVICEThread implantation acupuncture
Thread implantation acupuncture performed bilaterally at EX-B2 (L1) using polydioxanone (PDO) thread (26G × 38 mm) inserted subcutaneously to a depth of approximately 1-1.5 cm. The procedure is conducted once under aseptic conditions before surgery, combined with standard postoperative analgesic therapy.
DEVICESham thread implantation acupuncture
Sham thread embedding acupuncture performed bilaterally at EX-B2 (L1) using a blunt needle without thread insertion, mimicking the procedure but without embedding material. Participants also receive standard postoperative therapy.
Sponsors
Indonesia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Blinding will be applied to participants and outcome assessors. Group allocation will not be disclosed to them to minimize assessment bias.
Intervention model description
The intervention group will receive thread implantation acupuncture, while the control group will receive sham thread implantation acupuncture.
Eligibility
Sex/Gender
ALL
Age
21 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Living kidney donors scheduled to undergo laparoscopic living donor nephrectomy. * Aged 21-60 years. * Willing to participate and able to sign written informed consent
Exclusion criteria
* Hypersensitivity to thread-embedding acupuncture (TEA). * History of keloid formation or tendency to develop keloids. * Skin disorders at or near the planned TEA insertion sites. * Neurological abnormalities or lower-limb deficits on physical examination. * History of spinal surgery or scheduled for spinal surgery within the next 7 months. * Scoliosis based on clinical examination. * Other causes of low back pain, such as inflammatory spondylitis, spinal infection, or tumor. * Planning to become pregnant within 7 months after LNDH. * Body Mass Index (BMI) \< 18 kg/m². * Uncontrolled diabetes mellitus.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Intensity (Visual Analogue Scale) | From baseline to postoperative Day 14 | Visual Analogue Scale (0-100 mm) measured at Day 0 (baseline), Day 1, 2, 3, and 14 post-surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of Life (Short Form-36) | Baseline and Day 14. | Short Form-36 questionnaire assessing eight domains of quality of life at Day 0 and Day 14. |
| Analgesic Use | Day 0-14. | Total postoperative paracetamol dose used within 14 days. |
| Adverse Events Adverse Events Adverse Events | Up to Day 14 | Frequency and type of adverse reactions (pain, bruising, infection, thread extrusion). |
Countries
Indonesia
Outcome results
None listed