Electroacupuncture Analgesia for Colonoscopy

Study Overview
=================
Brief Summary
-----------------
Background: Colonoscopy is often regarded as a painful and unpleasant procedure. Electroacupuncture (EA) has been used successfully to treat pain of various origins, but few good-quality studies have evaluated its role in treating pain and anxiety during colonoscopy. Objective: To investigate the efficacy of EA in reducing procedure-related pain and the consumption of sedatives/analgesics during colonoscopy. Design: Prospective, randomized, double-blind, sham-controlled study. Subjects: One hundred and twenty eight consecutive patients undergoing first-time elective day-case colonoscopy without previous experience of acupuncture will be recruited. Interventions: Patients will be randomized to receive either 45 minutes of EA or sham acupuncture (SA) before colonoscopy. The acupoints relevant to the treatment of abdominal pain, including Zusanli, Hegu, and Neiguan will be used. For the SA group, blunt-tip needles will be placed (without skin penetration) 15 mm away from the acupoints. Foam blocks will be used to stabilize the needles and to blind the patients and endoscopists to the treatment allocation. EA and SA will be continued throughout colonoscopy. A mixture of Propofol and Alfentanil, delivered by a patient-controlled syringe pump, will be used for sedation/analgesia in both groups. Outcome measures: Primary outcome: doses of patient-controlled sedation/analgesia consumed. Secondary outcomes: pain and satisfaction scores according to a visual analog scale, cecal intubation rate/time, and episodes of hypotension/desaturation.

Official Title
-----------------
Electroacupuncture Analgesia for Colonoscopy: a Prospective, Randomized, Double-blind, Sham-controlled Study

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Procedure: Electroacupuncture
* Procedure: Sham acupuncture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Consecutive patients (aged between 18 and 60 years) undergoing first-time elective day-case colonoscopy Patients with American Society of Anesthesiologists (ASA) grading I-II Informed consent available Exclusion criteria: Patients with previous experience of acupuncture Patients with previous history of colorectal surgery Patients who are diagnosed with irritable bowel syndrome according to Rome III criteria 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 Patients who are allergic to the acupuncture needles or Propofol/Alfentanil

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electroacupuncture<br> | Procedure: Electroacupuncture<br>* Patients randomized to the experimental group will receive electroacupuncture at acupoints relevant to the treatment of abdominal pain and anxiety, including Zusanli (stomach meridian ST-36), Hegu (large intestine meridian LI-4), and Neiguan (pericardium meridian PC-6). Electric stimulation will be employed to the needles<br>|
| Active Comparator: Sham acupuncture<br> | Procedure: Sham acupuncture<br>* Sterile blunt-tip needles will be placed (without skin penetration) 15 mm away from the acupoints. Pseudostimulation will be given by deliberately connecting the needle to the incorrect output socket of the electroacupuncture device, thus there will be no flow of electric current.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose of patient-controlled sedation/analgesia consumed |  | During the procedure (up to 1 day) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score | Using a 10-cm unscaled visual analog scale; 0 = no pain, 10 = very painful | During the procedure (up to 1 day) | 
| Patients' satisfaction score | Using a 10-cm unscaled visual analog scale; 0 = not satisfied, 10 = very satisfied | During the procedure (up to 1 day) | 
| Patients' willingness to repeat the procedure |  | Up to 1 day | 
| Endoscopists' satisfaction score | Using a 10-cm unscaled visual analog scale; 0 = not satisfied, 10 = very satisfied | During the procedure (up to 1 day) | 
| Cecal intubation rate | Complete colonoscopy is defined as identification of ileocecal valve | During the procedure (up to 1 day) | 
| Cecal intubation time | The time from introduction of the colonoscope to the cecum | During the procedure (up to 1 day) | 
| Total procedure time |  | During the procedure (up to 1 day) | 
| Episodes of hypotension | Defined as systolic blood pressure <90 mmHg | During the procedure (up to 1 day) | 
| Episodes of desaturation | Defined as SaO2 <90% | During the procedure (up to 1 day) |