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Auricular Acupuncture in Postoperative Pain

Primary Purpose

Acupuncture

Status
Completed
Phase
Phase 4
Locations
Austria
Study Type
Interventional
Intervention
electrical auricular acupuncture
P-Stim™ devices were applied without electrical stimulation and acupuncture.
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acupuncture focused on measuring auricular acupuncture, postoperative pain, opioid consumption, laparoscopic surgery, ACUPUNCTURE THERAPY (IM) + EAR, EXTERNAL (IM)

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Medical University Vienna

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

electrical auricular acupuncture

pstim device without acupuncture

Arm Description

Patients in the acupuncture group received titan disposable needles (27-gauge, 3 mm length; Biegler GmbH, Mauerbach, Austria), which were inserted in the dominant ear at the following acupuncture points: shen men, thalamus and one segmental organ-specific point. Acupuncture points were identified by measuring skin resistance, using an electrical conductance meter (multipoint selection pen™, Biegler GmbH, Mauerbach, Austria). The needles were connected to the P-Stim™ device and received continuous low frequency electro acupuncture using P-Stim™ (constant current: 1 Hz biphasic, 2 mA) for 72 hours postoperatively. Acupuncture was performed by a specialist with 15 years experience in this technique.

Patients in the control group received electrodes without needles and the P-Stim™ devices were applied without electrical stimulation.

Outcomes

Primary Outcome Measures

mean postoperative pain (VAS score)

Secondary Outcome Measures

consumption of piritramide postoperatively

Full Information

First Posted
December 9, 2009
Last Updated
April 7, 2015
Sponsor
Medical University of Vienna
Collaborators
Department of Anesthesiology, General Intensive Care Medicine and Pain Control
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1. Study Identification

Unique Protocol Identification Number
NCT01030029
Brief Title
Auricular Acupuncture in Postoperative Pain
Official Title
Auricular Acupuncture in Postoperative Pain: a Randomized Controlled Trail
Study Type
Interventional

2. Study Status

Record Verification Date
January 2006
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
February 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Medical University of Vienna
Collaborators
Department of Anesthesiology, General Intensive Care Medicine and Pain Control

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acupuncture
Keywords
auricular acupuncture, postoperative pain, opioid consumption, laparoscopic surgery, ACUPUNCTURE THERAPY (IM) + EAR, EXTERNAL (IM)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
electrical auricular acupuncture
Arm Type
Active Comparator
Arm Description
Patients in the acupuncture group received titan disposable needles (27-gauge, 3 mm length; Biegler GmbH, Mauerbach, Austria), which were inserted in the dominant ear at the following acupuncture points: shen men, thalamus and one segmental organ-specific point. Acupuncture points were identified by measuring skin resistance, using an electrical conductance meter (multipoint selection pen™, Biegler GmbH, Mauerbach, Austria). The needles were connected to the P-Stim™ device and received continuous low frequency electro acupuncture using P-Stim™ (constant current: 1 Hz biphasic, 2 mA) for 72 hours postoperatively. Acupuncture was performed by a specialist with 15 years experience in this technique.
Arm Title
pstim device without acupuncture
Arm Type
Placebo Comparator
Arm Description
Patients in the control group received electrodes without needles and the P-Stim™ devices were applied without electrical stimulation.
Intervention Type
Device
Intervention Name(s)
electrical auricular acupuncture
Other Intervention Name(s)
P-Stim® The stimulator consists of a microcontroller and a bit-coded ST62T60BM6 interface, which produce defined waves of electrical stimuli
Intervention Description
Patients in the acupuncture group received titan disposable needles (27-gauge, 3 mm length; Biegler GmbH, Mauerbach, Austria), which were inserted in the dominant ear at the following acupuncture points: shen men, thalamus and one segmental organ-specific point [2]. Acupuncture points were identified by measuring skin resistance, using an electrical conductance meter (multipoint selection pen™, Biegler GmbH, Mauerbach, Austria). The needles were connected to the P-Stim™ device and received continuous low frequency electro acupuncture using P-Stim™ (constant current: 1 Hz biphasic, 2 mA) for 72 hours postoperatively. Acupuncture was performed by a specialist with 15 years experience in this technique.
Intervention Type
Device
Intervention Name(s)
P-Stim™ devices were applied without electrical stimulation and acupuncture.
Intervention Description
Patients in the control group received electrodes without needles and the P-Stim™ devices were applied without electrical stimulation.
Primary Outcome Measure Information:
Title
mean postoperative pain (VAS score)
Time Frame
0,2,24,48,72 hours
Secondary Outcome Measure Information:
Title
consumption of piritramide postoperatively
Time Frame
0,2,24,48,72 hours postoperatively

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Holzer, MD
Organizational Affiliation
Medical University Vienna, Department of Anesthesiology and General Intensive Care Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria

12. IPD Sharing Statement

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Auricular Acupuncture in Postoperative Pain

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