Pain
Conditions
Brief summary
Background: Colonoscopy is often regarded as a painful and unpleasant procedure. Transcutaneous Electric Nerve Stimulation on Acupoints (Acu-TENS) is a non-invasive modality that 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 Acu-TENS in reducing procedure-related pain and the consumption of sedatives/analgesics during colonoscopy. Design: Prospective, randomized, placebo-controlled study. Subjects: One hundred and twenty eight consecutive patients undergoing first-time elective day-case colonoscopy without previous experience of acupuncture/Acu-TENS will be recruited. Interventions: Patients will be randomized to receive either 45 minutes of Acu-TENS or placebo-TENS before colonoscopy. The acupoints relevant to the treatment of abdominal pain and distension, including Zusanli, Hegu, Neiguan, Tianshu, and Dachangshu will be used. For the placebo-TENS group, a non-conductive plastic film will be placed between the acupoint and the electrode so that no current will be transmitted. Acu-TENS and placebo-TENS 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.
Interventions
PROCEDUREAcu-TENS
Patients randomized to the experimental group will receive Acu-TENS on acupoints relevant to the treatment of abdominal pain and distension, including Zusanli (stomach meridian ST-36), Hegu (large intestine meridian LI-4), Neiguan (pericardium meridian PC-6), Tianshu (stomach meridian ST-25), and Dachangshu (bladder meridian BL-25).
PROCEDUREPlacebo-TENS
Patients randomized to the control group will receive placebo-TENS at the same acupoints.
Sponsors
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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 or Acu-TENS * 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 Acu-TENS electrodes or Propofol/Alfentanil
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose of patient-controlled sedation/analgesia consumed | During the procedure (up to 1 day) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Pain score | During the procedure (up to 1 day) | Using a 10-cm unscaled visual analog scale; 0 = no pain, 10 = very painful |
| 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% |
| Cecal intubation time | During the procedure (up to 1 day) | The time from introduction of the colonoscope to the cecum |
Countries
China
Outcome results
None listed