Postoperative Muscular Pain, ETOIMS (Electrical Twitch Obstructive Intramuscular Stimulation)

Phase 3UnknownNCT03619343

Yonsei University44 enrolled

Overview

Pancreaticoduodenectomy is inevitably an operation requiring extensive skin and muscle incision, resulting in postoperative pain resulting in limitation of the patient's early exercise and function. ETOIMS(Electrical Twitch Obstructive Intramuscular Stimulation) is used to relieve muscle pain and relax muscles. ETOIMS is a method to relieve pain by stimulating muscle in myofascial pain syndrome. ETOIMS as an effective new treatment for pain after pylorus preserving pancreaticoduodenectomy.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Disease Status of Pancreatobiliary Tract , ( Especially Who Need to Undergo Pancreaticoduodenectomy)

Interventions

ETOIMS(Electrical Twitch Obtaining Intramuscular Stimulation)PROCEDURE

When the abdominal wound is closed, the operator performs needle insertion at 14 sites near the incision site under the guidance of ultrasonography. When the needle is in the abdominal muscle, the operator performs muscle stimulation for about 10 seconds per needle insertion.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients undergoing pancreatoduodenectomy in Gangnam Severance Hospital, Seoul, Korea * Patients who are able to perform daily activities before surgery and were able to walk independently. * Adults over 20 Exclusion Criteria: * Patients with history of previous open surgery * Patients who are not able to exercise due to severe musculoskeletal pain except surgery-related diseases * Patients who can not walk because of difficulty breathing related to myalgia * Patients who can not exercise due to severe musculoskeletal pain * Patients who had a limb defect before surgery and were unable to walk without assistive devices and others * Pregnant / lactating mothers * Patients who have cognitive impairment and can not answer the questionnaire * Patients with Pacemaker * Patients who can not read the consent form

Locations (1)

GangnamSeverance Hospital

Seoul, South Korea

RECRUITING

Outcomes

Primary Outcomes

Pain: VAS (visual analogue scale)

The primary outcome of this study was the postoperative pain score (VAS score) in patients undergoing ETOIMS during surgery. The type of surgery in the experimental group and the control group is the same and the same analgesic agent (IV PCA, Wound PCA) is used. The pain score is measured at 7 o'clock every morning from the day following surgery to discharge (about Postoperative day 10) to confirm the reduced pattern.

Time frame: AM 7:00 morning at Preoperative day and the day following surgery before discharge (Postoperative day 1 - Postoperative day 10)

Data from ClinicalTrials.gov

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