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

NCT06517069 | Recruiting

• 1 other identifier: Kang
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Visceral Pain

Outcome Measures

Primary Outcomes (1)

• the VAS score of postoperative visceral pain

  the visual analogue scale of postoperative visceral pain,The basic method is to use a swimming scale about 10cm long, marked with 10 scales on one side, and "0" and "10" at each end, with 0 being painless and 10 being the most unbearable pain.

  30 minutes after surgery、6 hours after surgery、24 hours after surgery、48 hours after surgery

Study Arms (4)

TEAS combined with Oxycodone

EXPERIMENTAL

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

Other: TEAS; Drug: Oxycodone

TEAS

EXPERIMENTAL

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.

Other: TEAS

Oxycodone

EXPERIMENTAL

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

Drug: Oxycodone

Comparator

NO INTERVENTION

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.

Interventions

TEAS 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

TEAS; TEAS combined with Oxycodone

Oxycodone DRUG

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

Oxycodone; TEAS combined with Oxycodone

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yangzhou University: lead

Study Sites (1)

Affiliated Hospital of Yangzhou University

Yangzhou, Jiangsu, 225000, China

RECRUITING

MeSH Terms

Conditions

Visceral Pain

Interventions

Oxycodone

Condition Hierarchy (Ancestors)

Nociceptive Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Central Study Contacts

Meiyu Liu

CONTACT

+86 177 6198 0727; myliu@yzu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 18, 2024
• First Posted: July 24, 2024
• Study Start: May 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: July 1, 2025
• Last Updated: July 30, 2024

Record last verified: 2024-07

Locations

CN (1)