Electroacupuncture Analgesia for Colonoscopy
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|ClinicalTrials.gov Identifier: NCT01368393|
Recruitment Status : Completed
First Posted : June 8, 2011
Last Update Posted : December 17, 2012
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.
To investigate the efficacy of EA in reducing procedure-related pain and the consumption of sedatives/analgesics during colonoscopy.
Prospective, randomized, double-blind, sham-controlled study.
One hundred and twenty eight consecutive patients undergoing first-time elective day-case colonoscopy without previous experience of acupuncture will be recruited.
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.
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 or disease||Intervention/treatment||Phase|
|Pain||Procedure: Electroacupuncture Procedure: Sham acupuncture||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||128 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Care Provider, Outcomes Assessor)|
|Official Title:||Electroacupuncture Analgesia for Colonoscopy: a Prospective, Randomized, Double-blind, Sham-controlled Study|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||October 2012|
|Actual Study Completion Date :||October 2012|
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.
- Dose of patient-controlled sedation/analgesia consumed [ Time Frame: During the procedure (up to 1 day) ]
- Pain score [ Time Frame: During the procedure (up to 1 day) ]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) ]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 ]
- Endoscopists' satisfaction score [ Time Frame: During the procedure (up to 1 day) ]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) ]Complete colonoscopy is defined as identification of ileocecal valve
- Cecal intubation time [ Time Frame: During the procedure (up to 1 day) ]The time from introduction of the colonoscope to the cecum
- Total procedure time [ Time Frame: During the procedure (up to 1 day) ]
- Episodes of hypotension [ Time Frame: During the procedure (up to 1 day) ]Defined as systolic blood pressure <90 mmHg
- Episodes of desaturation [ Time Frame: During the procedure (up to 1 day) ]Defined as SaO2 <90%
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01368393
|Prince of Wales Hospital, The Chinese University of Hong Kong|
|Hong Kong SAR, China|
|Principal Investigator:||Simon SM Ng, MD||Chinese University of Hong Kong|