Electroacupuncture Analgesia for Colonoscopy

Phase 3

Completed

• Conditions: Pain
• Interventions: Procedure: Electroacupuncture; Procedure: Sham acupuncture

• Registration Number: NCT01368393
• Lead Sponsor: Chinese University of Hong Kong

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-06-06
• Study First Submitted QC: 2011-06-06
• Study First Posted: 2011-06-08
• Study Start: 2011-10
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-14
• Last Update Posted: 2012-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Electroacupuncture	Electroacupuncture	-
Sham acupuncture	Sham acupuncture	-

Primary Outcome Measures

Name	Time	Method
Dose of patient-controlled sedation/analgesia consumed	During the procedure (up to 1 day)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Prince of Wales Hospital, The Chinese University of Hong Kong; 🇨🇳 Hong Kong SAR, China