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Electroacupuncture Analgesia for Colonoscopy

The Chinese University of Hong Kong logo

The Chinese University of Hong Kong

Status and phase

Completed
Phase 3

Conditions

Pain

Treatments

Procedure: Sham acupuncture
Procedure: Electroacupuncture

Study type

Interventional

Funder types

Other

Identifiers

NCT01368393
CRE-2010.404

Details and patient eligibility

About

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.

Enrollment

128 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

128 participants in 2 patient groups

Electroacupuncture
Experimental group
Treatment:
Procedure: Electroacupuncture
Sham acupuncture
Active Comparator group
Treatment:
Procedure: Sham acupuncture

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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