Electroacupuncture Analgesia for EUS: a Randomized Controlled Trial

February 16, 2017 updated by: Anthony Teoh, Chinese University of Hong Kong

Electroacupuncture Analgesia for Endoscopic Ultrasound (EUS): a Prospective, Randomized, Double-blinded, Sham-controlled Study

Endoscopic ultrasound (EUS) has evolved to become an important diagnostic tool and its interventional role is rapidly expanding. In order to improve patient's comfort and satisfaction during and after procedure, the use of sedation is usually recommended. However, sedation may be associated with serious adverse events of including hypotension, aspiration and respiratory depression. Moreover, the cost of performing the procedure would be increased due to the costs of the medications and the need of additional personnel in monitoring of the patient. As a result, the drive to seek alternative and safer approaches of pain-relief during EUS is ever present. Electroacupuncture (EA) has been used in Traditional Chinese Medicine (TCM) for more than 2000 years. The benefits and success of EA in treatment of acute and chronic pain of various origins have been well-recognised. Many researches have been performed to address the role of EA in treating pain and anxiety during OGD and colonoscopy. However, only limited data is availabe in the Chinese and the Western literature concerning the use of EA in EUS. Therefore it is worthwhile to conduct a well-designed study to evaluate the role of EA in treating pain during EUS.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

128

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Prince of Wales Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Consecutive patients (aged between 18 and 80 years) undergoing first-time elective day-case EUS, patients with American Society of Anesthesiologists (ASA) grading I-II, and informed consent available.

Exclusion Criteria:

  • Patients with previous experience of acupuncture, patients with coagulopathy, patients with previous history of upper gastrointestinal surgery, patients who are diagnosed with irritable bowel syndrome according to Rome III criteria, 12 patients with chronic pain syndrome, patients with psychiatric disorder, patients with poor cognitive function, patients with renal impairment, patients with obstructive sleep apnea syndrome, patients with cardiac arrhythmias, patients with cardiac pacemaker, patients who are pregnant, and patients who are allergic to the acupuncture needles or Propofol/Alfentanil.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Electroacupuncture
Patients randomized to the experimental group will receive EA at acupoints relevant to the treatment of abdominal pain and anxiety. Selection of these acupoints is based on a consensus between the acupuncturist of the study (Leung WW) and several professors of the Diploma Course of Clinical Acupuncture of the School of Professional and Continuing Education, University of Hong Kong.
Procedure: Electroacupuncture
Placebo Comparator: Sham Acupuncture
Patients randomized to the control group will receive Sham acupuncture with sterile blunt-tip needles
Procedure: Electroacupuncture

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Consumption of propofol
Time Frame: 1 day
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

February 16, 2014

First Submitted That Met QC Criteria

February 16, 2014

First Posted (Estimate)

February 19, 2014

Study Record Updates

Last Update Posted (Actual)

February 17, 2017

Last Update Submitted That Met QC Criteria

February 16, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • CRE-2011.324

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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