Electroacupuncture Analgesia for Colonoscopy

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

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Procedure: Electroacupuncture; Procedure: Sham acupuncture

• Study Type: Interventional
• Enrollment (Actual): 128
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Hong Kong SAR, China
    • Prince of Wales Hospital, The Chinese University of Hong Kong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Electroacupuncture	Procedure: Electroacupuncture; 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
Active Comparator: Sham acupuncture	Procedure: Sham acupuncture; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: June 6, 2011
• First Submitted That Met QC Criteria: June 6, 2011
• First Posted (Estimate): June 8, 2011

Study Record Updates

• Last Update Posted (Estimate): December 17, 2012
• Last Update Submitted That Met QC Criteria: December 14, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: CRE-2010.404