A New Treatment Modality for the Postoperative Muscular Pain Management in Pylorus Preserving Pancreaticoduodenectomy: a Double-blind Randomized Control Trial
Trial Snapshot
- Phase
- Phase 3
- Sponsor
- Yonsei University
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- Pain: VAS (visual analogue scale)
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
No ETOIMS arm
When the abdominal wound is closed, the operator performs needle insertion at 14 sites near the incision site under the guidance of ultrasonography.
Intervention: ETOIMS(Electrical Twitch Obtaining Intramuscular Stimulation) (Procedure)
ETOIMS arm
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.
Intervention: ETOIMS(Electrical Twitch Obtaining Intramuscular Stimulation) (Procedure)
Outcomes
Primary Outcomes
Pain: VAS (visual analogue scale)
Time Frame: AM 7:00 morning at Preoperative day and the day following surgery before discharge (Postoperative day 1 - Postoperative day 10)
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Joon Seong Park
Professor,
Yonsei University