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

NCT06197620 | Completed

• 1 other identifier: 23-08-1375
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Laparoscopic Living Donor Nephrectomy; Post Operative Acute Pain; Quality of Life; Thread Embedding Acupuncture

Outcome Measures

Primary Outcomes (1)

• Pain severity with Visual Analog Scale

  Visual Analog Scale (VAS) that score 0 is no pain to 100 the worse pain A higher result means worse outcomes and lower result means better outcomes

  7 days before laparoscopic living donor nephrectomy and on 1st, 2nd, 14th day after laparoscopic living donor nephrectomy procedure

Secondary Outcomes (1)

• Quality of Life with Short Form 36

  7 days before laparoscopic living donor nephrectomy, and on 1st, 2nd, and 14th day after laparoscopic living donor nephrectomy procedure

Study Arms (1)

Thread Embedding Acupuncture and Standard Therapy

EXPERIMENTAL

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.

Other: Thread embedding acupuncture and standard therapy

Interventions

Thread embedding acupuncture and standard therapy OTHER

In the treatment, thread embedding acupuncture was performed using a needle containing polydioxanone (PDO) thread at the EX-B2 acupuncture point (12.5 mm lateral to the spinous process) at the level of the 1st lumbar vertebra with an insertion angle perpendicular to the skin surface. All patients are also given standard therapy after surgery in the form of intravenous Paracetamol 1000 mg, 3 times a day.

Thread Embedding Acupuncture and Standard Therapy

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Faculty of Medicine Universitas Indonesia

Jakarta Pusat, Jakarta Special Capital Region, 10430, Indonesia

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• KEPK FKUI RSCM

  Urology, University of Indonesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: November 23, 2023
• First Posted: January 9, 2024
• Study Start: October 20, 2023
• Primary Completion: December 22, 2023
• Study Completion: January 3, 2024
• Last Updated: January 23, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share

Locations

ID (1)