Analgesic Effect of TENS-WAA Combined With Tramadol Hydrochloride During Oocyte Retrieval Surgery

N/ANot Yet RecruitingNCT07212127

First Affiliated Hospital of the Chinese People's Liberation Army Naval Medical University60 enrolled

Overview

This study is a single-centre randomised controlled trial. It aimed to evaluate the efficacy and safety of transcutaneous electrical nerve stimulation based on wrist-ankle acupuncture theory(TENS-WAA) combined with tramadol hydrochloride for analgesia during transvaginal ultrasound-guided oocyte retrieval, by comparing the analgesic effects and the prevention of postoperative nausea and vomiting between the TENS-WAA combined with tramadol hydrochloride group (experimental group) and the sham TENS-WAA combined with tramadol hydrochloride group (control group). Participants were randomly assigned to the experimental or control group. The experimental group received percutaneous electrical nerve stimulation based on wrist-ankle acupuncture theory 30 minutes prior to the procedure, at a frequency of 2Hz with current intensity adjusted to the maximum tolerable level.Tramadol hydrochloride 100mg was administered intramuscularly 20 minutes before surgery. The control group received sham stimulation at the lowest intensity under identical conditions. The primary outcome measure was the Visual Analogue Scale (VAS). Secondary outcome measures included skin conductance response, postoperative nausea scale, and vomiting scale.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Oocyte Retrieval for IVF Pain

Interventions

Transcutaneous Electrical Nerve Stimulation based on Wrist-Ankle Acupuncture theory（TENS-WAA)DEVICE

Based on the theory of wrist and ankle needles, transcutaneous electrical nerve stimulation is a kind of analgesic treatment device that combines wrist and ankle needles with transcutaneous electrical nerve stimulation, and can be worn on the human wrist and ankle. Transcutaneous Electrical Nerve Stimulation based on Wrist-Ankle Acupuncture Theory uses low-frequency electronic pulses to stimulate the entry point of the wrist-ankle needle, which has the advantages of easy to wear, concentration of the treatment site, safety of the treatment, and no needles.

Eligibility

Sex: FEMALEMin age: 21 YearsMax age: 42 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Females aged between 21 and 42 years. * Patients diagnosed with infertility requiring oocyte retrieval for in vitro fertilisation-embryo transfer. * Body Mass Index (BMI) 18.5 ≤ BMI ≤ 29.9 kg/m². * Regular menstrual cycles with ultrasound monitoring demonstrating dominant follicle development and ovulation during the natural cycle; good ovarian reserve: follicle-stimulating hormone (FSH) \< 10 IU/L, antral follicle count (AFC) \> 6, anti-Müllerian hormone (AMH) \> 1.5 ng/ml. * Undergoing ovarian stimulation therapy using follicle-stimulating hormone (FSH) or gonadotropin protocols. * Electing tramadol hydrochloride injection for analgesia during oocyte retrieval. * Voluntary participation with signed written informed consent. Exclusion Criteria: * History of other chronic pain conditions, or prolonged use of opioid medications, history of anaesthetic drug addiction, or chronic alcohol abuse. * Severe pelvic adhesions. * Presence of pacemakers or other implanted medical electronic devices. * Concurrent use of high-frequency surgical equipment, artificial heart-lung machines, medical shortwave therapy, or microwave therapy devices. * Presence of scarring or skin lesions at electrode application sites. * Severe anxiety, depression, or other psychiatric conditions impairing accurate description of sensations, or any other disorders potentially affecting pain perception. * Conditions contraindicating or affecting oocyte retrieval, such as coagulation disorders, acute pelvic inflammation, vaginitis, trichomoniasis, endometriomas, ovarian cysts. * Individuals with laparoscopically and/or ultrasonographically confirmed endometriosis. * Patients with ovarian hyporesponsiveness following conventional ovarian stimulation medication.

Outcomes

Primary Outcomes

Pain VAS score

VAS is used to assess pain. It is widely used in clinical practice in China. The basic method is to use a 10-cm long floating ruler with 10 scale marks on one side, with 0 and 10 marks at the two ends. 0 means no pain, and 10 means the most severe pain that is unbearable.

Time frame: Within 3 minutes following oocyte retrieval

Secondary Outcomes

Galvanic Skin Response

Galvanic Skin Response (GSR) is a bio-signal detection technique that reflects autonomic nervous system activity by measuring changes in skin conductance. Its core principle lies in the following: when an individual experiences emotional fluctuations, sympathetic nervous system excitation stimulates increased secretion from eccrine sweat glands. The electrolytes in sweat significantly alter the conductive properties of the skin surface, and these transient changes in conductance form the characteristic spikes of the GSR signal.

Time frame: during procedure

Nausea Rating Scale

The Nausea Assessment Scale is divided into four scores: 0 points (None) indicates no nausea sensation; 1 point (Mild) indicates a feeling of wanting to vomit but without muscle contractions; 2 points (Moderate) indicates spasmodic contractions of the diaphragm and chest/abdominal muscles but without expulsion of gastric contents; 3 points (Severe) indicates frequent muscle contractions with expulsion of gastric contents.

Time frame: 30 minutes after oocyte retrieval

Vomiting Rating Scale

The Vomiting Assessment Scale is divided into four scores: 0 points (None) indicates no vomiting; 1 point (Mild) indicates vomiting 1-2 times; 2 points (Moderate) indicates vomiting 3-4 times; 3 points (Severe) indicates vomiting more than 5 times with expulsion of large amounts of gastric contents.