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

NCT ID: NCT06517069

Last Updated: 2024-07-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2025-07-01

Brief Summary

To investigate the effect and feasibility of percutaneous acupoint stimulation combined with oxycodone on postoperative visceral pain in laparoscopic patients, and provided a clinical basis for optimizing perioperative pain management in laparoscopic patients.

Detailed Description

Patients aged 18-65 years old, BMI 18-30kg/m2, ASA grade I or II were selected for gynecologic laparoscopic surgery (laparoscopic ovarian tumor stripping, laparoscopic uterine fibroid stripping, laparoscopic total hysterectomy) under general anesthesia from May 2024 to July 2024. Exclusion criteria: Patients who were allergic to the drugs used in the study, had confusion or cognitive impairment, contraindicated percutaneous acupoint electrical stimulation, abnormal cardiopulmonary and liver and kidney function, history of analgesic drug use within one week, history of diabetes, myocardial infarction, or cerebrovascular accident. Exclusion criteria: patients dropped out of the experiment midway or the data was not completely collected, the surgical method changed midway, the operation duration was less than 30 minutes or more than 2 hours, and patients with opioid and addictive drug dependence

Conditions

Visceral Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

TEAS combined with Oxycodone

Bilateral Neiguan point (PC6), Zusanli point (ST36) and Sanyinjiao point (SP6) were selected. Use Huatuo electronic needle therapy device, Sulodine electric stimulation hand circle TEAS, Huatuo electronic needle therapy device parameter setting: Density wave, 2/10Hz, current intensity from weak to strong, until the patient can tolerate the maximum intensity (acid, numbness, distension, pain) is appropriate, after the Sulodine brand electrical stimulation bracelet is turned on, gradually increase the stimulation intensity, until the patient can tolerate the maximum intensity is appropriate, stimulation for 30min until anesthesia induction; Oxycodone 0.1mg/kg was injected intravenously 5 minutes before anesthesia induction

Group Type: EXPERIMENTAL

TEAS

Intervention Type: OTHER

Bilateral Neiguan point (PC6), Zusanli point (ST36) and Sanyinjiao point (SP6) were selected. Use Huatuo electronic needle therapy device, Sulodine electric stimulation hand circle TEAS, Huatuo electronic needle therapy device parameter setting: Density wave, 2/10Hz, current intensity from weak to strong, until the patient can tolerate the maximum intensity (acid, numbness, distension, pain) is appropriate, after the Sulodine brand electrical stimulation bracelet is turned on, gradually increase the stimulation intensity, until the patient can tolerate the maximum intensity is appropriate, stimulation for 30min until anesthesia induction

Oxycodone

Intervention Type: DRUG

Oxycodone 0.1mg/kg was injected intravenously 5 minutes before anesthesia induction

TEAS

Bilateral Neiguan point (PC6), Zusanli point (ST36) and Sanyinjiao point (SP6) were selected. Use Huatuo electronic needle therapy device, Sulodine electric stimulation hand circle TEAS, Huatuo electronic needle therapy device parameter setting: Density wave, 2/10Hz, current intensity from weak to strong, until the patient can tolerate the maximum intensity (acid, numbness, distension, pain) is appropriate, after the Sulodine brand electrical stimulation bracelet is turned on, gradually increase the stimulation intensity, until the patient can tolerate the maximum intensity is appropriate, stimulation for 30min until anesthesia induction; The same amount of normal saline was injected intravenously 5 minutes before anesthesia induction.

Group Type: EXPERIMENTAL

TEAS

Intervention Type: OTHER

Bilateral Neiguan point (PC6), Zusanli point (ST36) and Sanyinjiao point (SP6) were selected. Use Huatuo electronic needle therapy device, Sulodine electric stimulation hand circle TEAS, Huatuo electronic needle therapy device parameter setting: Density wave, 2/10Hz, current intensity from weak to strong, until the patient can tolerate the maximum intensity (acid, numbness, distension, pain) is appropriate, after the Sulodine brand electrical stimulation bracelet is turned on, gradually increase the stimulation intensity, until the patient can tolerate the maximum intensity is appropriate, stimulation for 30min until anesthesia induction

Oxycodone

Bilateral Neiguan point (PC6), Zusanli point (ST36) and Sanyinjiao point (SP6) were selected. Stick electrodes only but do not stimulate; Oxycodone 0.1mg/kg was injected intravenously 5 minutes before anesthesia induction

Group Type: EXPERIMENTAL

Oxycodone

Intervention Type: DRUG

Oxycodone 0.1mg/kg was injected intravenously 5 minutes before anesthesia induction

Comparator

Bilateral Neiguan point (PC6), Zusanli point (ST36) and Sanyinjiao point (SP6) were selected. Stick electrodes only but do not stimulate; The same amount of normal saline was injected intravenously 5 minutes before anesthesia induction.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

TEAS

Bilateral Neiguan point (PC6), Zusanli point (ST36) and Sanyinjiao point (SP6) were selected. Use Huatuo electronic needle therapy device, Sulodine electric stimulation hand circle TEAS, Huatuo electronic needle therapy device parameter setting: Density wave, 2/10Hz, current intensity from weak to strong, until the patient can tolerate the maximum intensity (acid, numbness, distension, pain) is appropriate, after the Sulodine brand electrical stimulation bracelet is turned on, gradually increase the stimulation intensity, until the patient can tolerate the maximum intensity is appropriate, stimulation for 30min until anesthesia induction

Intervention Type: OTHER

Oxycodone

Oxycodone 0.1mg/kg was injected intravenously 5 minutes before anesthesia induction

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Yangzhou University

OTHER

Sponsor Role: lead

Responsible Party

Wang wanxia

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Affiliated Hospital of Yangzhou University

Yangzhou, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Meiyu Liu

Role: CONTACT

myliu@yzu.edu

+86 177 6198 0727

Facility Contacts

Liu Meiyu, Director

Role: primary

meiyuliu@yzu.edu.cn

17761980727

Other Identifiers

Kang

Identifier Type: -

Identifier Source: org_study_id