Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
FEMALE
Healthy Volunteers
ID06517069

Effect of Transcutaneous Electrical Acupoint Stimulation Combined With Oxycodone on Postoperative Visceral Pain and Early Recovery Quality in Gynecologic Laparoscopic Patients

Led by Yangzhou University · Updated on 2024-07-30

120

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effect and feasibility of combining percutaneous acupoint stimulation with oxycodone to manage postoperative visceral pain in female patients undergoing gynecologic laparoscopic surgery. This study focuses on patients aged 18 to 65 years with specific health criteria, aiming to optimize pain control during the perioperative period. The research is conducted under general anesthesia for procedures such as ovarian tumor stripping, uterine fibroid stripping, and total hysterectomy. Participants are randomly assigned to one of four groups: transcutaneous electrical acupoint stimulation (TEAS) combined with oxycodone, TEAS alone, oxycodone alone, or a control group receiving neither active treatment. The TEAS involves stimulating specific points (Neiguan, Zusanli, and Sanyinjiao) using an electronic needle therapy device and an electrical stimulation bracelet for 30 minutes before anesthesia induction. Oxycodone is administered intravenously at a dose of 0.1 mg/kg five minutes before anesthesia. During the study, participants' postoperative visceral pain is assessed using the Visual Analog Scale (VAS) at several time points: 30 minutes, 6 hours, 24 hours, and 48 hours after surgery. The study also monitors early recovery quality and collects data related to safety and treatment feasibility. Participation lasts through the perioperative period, with careful data collection to evaluate pain management outcomes and treatment tolerability.

CONDITIONS

Brief Title

Effect of TEAS Combined With Oxycodone on Postoperative Visceral Pain in Gynecologic Laparoscopic Patients

Who Can Participate

Age: 18Years - 65Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18-65 years
  • American Society of Anesthesiologists grade I-II
  • Body mass index (BMI) 18.5-30 kg/m2
  • No ulceration or infection at the acupuncture stimulation site
Not Eligible

You will not qualify if you...

  • Allergic to the drugs used in the study
  • People with unclear consciousness or cognitive dysfunction
  • Contraindications to percutaneous acupoint electrical stimulation
  • Abnormal cardiopulmonary, liver, or kidney function
  • History of analgesic drug use within one week
  • History of diabetes, myocardial infarction, or cerebrovascular accident

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 2 hours (duration of surgery and intervention)

Participants receive transcutaneous electrical acupoint stimulation and/or oxycodone before and during gynecologic laparoscopic surgery under general anesthesia.

1 treatment visit during surgery

Post-operative Follow-up

Duration - 48 hours

Participants are monitored for postoperative visceral pain and recovery quality through assessments up to 48 hours after surgery.

Assessments at 30 minutes, 6 hours, 24 hours, and 48 hours after surgery

Trial Site Locations

Total: 1 location

1

Affiliated Hospital of Yangzhou University

Yangzhou, Jiangsu, China, 225000

Actively Recruiting

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Research Team

M

Meiyu Liu

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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