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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age21-42
SponsorFirst Affiliated Hospital of the Chinese People's Liberation Army Naval Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Electrical Stimulation GroupExperimental treatment 1 intervention
Group B: Sham electrical stimulation groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

1

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
2

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
3

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.

Time frame
30 minutes after oocyte retrieval

Other outcomes

Sponsors and contacts

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