Clinical trial NCT01030029: Auricular Acupuncture in Postoperative Pain
Official title: Auricular Acupuncture in Postoperative Pain: a Randomized Controlled Trail
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acupuncture
Keywords: auricular acupuncture
postoperative pain
opioid consumption
laparoscopic surgery
ACUPUNCTURE THERAPY (IM) + EAR, EXTERNAL (IM)
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
Collaborators: name: Department of Anesthesiology, General Intensive Care Medicine and Pain Control
First posted: 2009-12-10
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The effect of acupuncture for postoperative pain control remains controversial. We therefore studied the effects of electrical auricular acupuncture (AA) on postoperative opioid consumption in a randomized, patient-blinded clinical trial.

40 female patients undergoing laparoscopy were included. Anaesthetized patients were randomly assigned to receive AA (shen men, thalamus and one segmental organ-specific point) or electrodes and electrical stimulation for 72 hours. Postoperatively patients received 1 g paracetamol every 6 hours and additional piritramide on demand. A blinded observer obtained the doses of piritramide and the visual analogue pain scores (VAS) at 0, 2, 24, 48, and 72 hours.

It was the aim of our study to find out, whether auricular acupuncture reduces postoperative pain.

Detailed description: Postoperative pain treatment is a major issue in management of surgical patients. Goal of the treatment is a maximal effect with minimal side effects. There are various treatment options, including conventional pharmacological and complementary approaches. Acupuncture is a system with an empirical basis, which has been used in the treatment for centuries. The mechanisms can be partly explained in terms of endogenous pain inhibitory systems. Its use for pain relief has been supported by clinical trials and this has facilitated its use in pain clinics in most countries. Needle acupuncture and other forms of sensory stimulation produce similar physiological changes in humans and mammals, e.g. rhythmic discharges in nerve fibres, and the release of endogenous opioids. Besides acupuncture points located on "meridians" all over the body acupuncture points are also described on the ear. The stimulation of acupuncture points can be achieved by pressure, a mechanical action of needling, or electrical point stimulation. In chronic pain treatment acupuncture has been found to be more effective than other non-pharmacological therapies. Furthermore, continuous electrical stimulation of auricular acupuncture points improves the treatment of chronic cervical pain patients. Finally, acupuncture represents not only a therapeutically beneficial, but also a cost-effective treatment option. Auricular acupuncture is also known to be effective in treatment of acute postoperative pain.

The aim of our study is to investigate in a randomized, prospective, double - blind, and controlled design whether continuous electrical stimulation of auricular acupuncture points results in reduction of postoperative pain.

Eligibility criteria: Inclusion Criteria:

* female ASA physical status I-III patients undergoing elective gynaecological laparoscopy

  * (surgery in cases of infertility, ovarian cyst removal, adhesiolysis, adnexal surgery,endometriosis, or hysterectomy),
* aged from 18-60 years.

Exclusion Criteria:

* patients with a history of drug abuse,
* regular use of sedatives,
* chronic analgesic medication,
* neurological or psychiatric diseases,
* adverse reaction to sevoflurane or paracetamol,
* ASA physical status \> III,
* pacemaker, or a history of acupuncture treatment.

Primary outcomes:
measure: mean postoperative pain (VAS score)
timeFrame: 0,2,24,48,72 hours
Secondary outcomes:
measure: consumption of piritramide postoperatively
timeFrame: 0,2,24,48,72 hours postoperatively
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University Vienna
Study officials:
affiliation: Medical University Vienna, Department of Anesthesiology and General Intensive Care Medicine
name: Andrea Holzer, MD
role: PRINCIPAL_INVESTIGATOR
References: