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Electroacupuncture Analgesia for Colonoscopy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Simon S. M. Ng, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01368393
First received: June 6, 2011
Last updated: December 14, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Pain
 Procedure: Electroacupuncture
Procedure: Sham acupuncture
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Electroacupuncture Analgesia for Colonoscopy: a Prospective, Randomized, Double-blind, Sham-controlled Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • Dose of patient-controlled sedation/analgesia consumed [ Time Frame: During the procedure (up to 1 day) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain score [ Time Frame: During the procedure (up to 1 day) ] [ Designated as safety issue: No ]
    Using a 10-cm unscaled visual analog scale; 0 = no pain, 10 = very painful

  • Patients' satisfaction score [ Time Frame: During the procedure (up to 1 day) ] [ Designated as safety issue: No ]
    Using a 10-cm unscaled visual analog scale; 0 = not satisfied, 10 = very satisfied

  • Patients' willingness to repeat the procedure [ Time Frame: Up to 1 day ] [ Designated as safety issue: No ]
  • Endoscopists' satisfaction score [ Time Frame: During the procedure (up to 1 day) ] [ Designated as safety issue: No ]
    Using a 10-cm unscaled visual analog scale; 0 = not satisfied, 10 = very satisfied

  • Cecal intubation rate [ Time Frame: During the procedure (up to 1 day) ] [ Designated as safety issue: No ]
    Complete colonoscopy is defined as identification of ileocecal valve

  • Cecal intubation time [ Time Frame: During the procedure (up to 1 day) ] [ Designated as safety issue: No ]
    The time from introduction of the colonoscope to the cecum

  • Total procedure time [ Time Frame: During the procedure (up to 1 day) ] [ Designated as safety issue: No ]
  • Episodes of hypotension [ Time Frame: During the procedure (up to 1 day) ] [ Designated as safety issue: Yes ]
    Defined as systolic blood pressure <90 mmHg

  • Episodes of desaturation [ Time Frame: During the procedure (up to 1 day) ] [ Designated as safety issue: Yes ]
    Defined as SaO2 <90%


Enrollment: 128
Study Start Date: October 2011
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01368393

Locations
China
Prince of Wales Hospital, The Chinese University of Hong Kong
Hong Kong SAR, China
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: Simon SM Ng, MD Chinese University of Hong Kong
  More Information

No publications provided

Responsible Party: Simon S. M. Ng, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT01368393     History of Changes
Other Study ID Numbers: CRE-2010.404
Study First Received: June 6, 2011
Last Updated: December 14, 2012
Health Authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

ClinicalTrials.gov processed this record on May 16, 2013