Electroacupuncture Analgesia for Colonoscopy

NCT01368393 | Completed Phase 3

• 1 other identifier: CRE-2010.404
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• Dose of patient-controlled sedation/analgesia consumed

  During the procedure (up to 1 day)

Secondary Outcomes (9)

• Pain score

  During the procedure (up to 1 day)

• Patients' satisfaction score

  During the procedure (up to 1 day)

• Patients' willingness to repeat the procedure

  Up to 1 day

• Endoscopists' satisfaction score

  During the procedure (up to 1 day)

• Cecal intubation rate

  During the procedure (up to 1 day)

Study Arms (2)

Electroacupuncture

EXPERIMENTAL

Procedure: Electroacupuncture

Sham acupuncture

ACTIVE COMPARATOR

Procedure: Sham acupuncture

Interventions

Electroacupuncture PROCEDURE

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

Electroacupuncture

Sham acupuncture PROCEDURE

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.

Sham acupuncture

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital, The Chinese University of Hong Kong

Hong Kong SAR, China

Location

MeSH Terms

Conditions

Pain

Interventions

Electroacupuncture

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Study Officials

• Simon SM Ng, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 6, 2011
• First Posted: June 8, 2011
• Study Start: October 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: December 17, 2012

Record last verified: 2012-12

Locations

CN (1)