Status:
COMPLETED
Pulsed Electromagnetic Fields for Postoperative Analgesia: A Randomized, Triple-Masked, Sham-Controlled Pilot Study
Lead Sponsor:
University of California, San Diego
Conditions:
Postoperative Pain, Acute
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Pulsed electromagnetic field therapy is a possible method of pain control involving the application of electromagnetic energy (also termed nonthermal, pulsed, shortwave radiofrequency therapy). Food a...
Detailed Description
The proposed study will be a randomized, participant- and observer-masked, sham-controlled, parallel-arm, human participants pilot study with two primary aims: Specific Aim 1: To determine the feasib...
Eligibility Criteria
Inclusion
- Adult patients of at least 18 years of age undergoing one of these primary surgical procedures:
- non-mastectomy breast surgery with a single-injection paravertebral nerve block
- laparoscopic cholecystectomy
- laparoscopic sleeve gastrectomy
- percutaneous nephrolithotomy
- ventral hernia repair
- inguinal hernia repair
- knee or hip arthroplasty
- foot/ankle surgery with at least moderate pain anticipated
- shoulder acromioclavicular joint repair, labral repair, subacromial decompression, or Bankart repair (without rotator cuff repair)
- hand/forearm/elbow surgery with at least moderate pain anticipated
- spinal surgery with at least moderate pain anticipated
Exclusion
- concurrent use of an implanted pulse generator (e.g., cardiac pacemaker)
- pregnancy
- incarceration
- chronic opioid/tramadol use (daily use within the 2 weeks prior to surgery and duration of use \> 4 weeks)
- neuro-muscular deficit of the surgical area/limb
- a planned postoperative perineural local anesthetic infusion
Key Trial Info
Start Date :
July 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 3 2024
Estimated Enrollment :
119 Patients enrolled
Trial Details
Trial ID
NCT05399355
Start Date
July 18 2022
End Date
April 3 2024
Last Update
July 31 2024
Active Locations (1)
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1
University of California, San Diego
San Diego, California, United States, 92103