Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Auricular Acupuncture in Postoperative Pain

This study has been completed.
Sponsor:
Collaborator:
Departement of Anaesthesia, General Intensive Care and Pain Control
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01030029
First received: December 9, 2009
Last updated: May 28, 2010
Last verified: January 2006
  Purpose

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.


Condition Intervention Phase
Acupuncture
Device: electrical auricular acupuncture
Device: P-Stim™ devices were applied without electrical stimulation and acupuncture.
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Auricular Acupuncture in Postoperative Pain: a Randomized Controlled Trail

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • mean postoperative pain (VAS score) [ Time Frame: 0,2,24,48,72 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • consumption of piritramide postoperatively [ Time Frame: 0,2,24,48,72 hours postoperatively ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: January 2006
Study Completion Date: February 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: electrical auricular acupuncture
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.
Device: electrical auricular acupuncture
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.
Other Name: P-Stim® The stimulator consists of a microcontroller and a bit-coded ST62T60BM6 interface, which produce defined waves of electrical stimuli
Placebo Comparator: pstim device without acupuncture
Patients in the control group received electrodes without needles and the P-Stim™ devices were applied without electrical stimulation.
Device: P-Stim™ devices were applied without electrical stimulation and acupuncture.
Patients in the control group received electrodes without needles and the P-Stim™ devices were applied without electrical stimulation.

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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01030029

Locations
Austria
Medical University Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Departement of Anaesthesia, General Intensive Care and Pain Control
Investigators
Principal Investigator: Andrea Holzer, MD Medical University Vienna, Department of Anesthesiology and General Intensive Care Medicine
  More Information

No publications provided

Responsible Party: Andrea Holzer, MD, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01030029     History of Changes
Other Study ID Numbers: 08/2009, 262/2005
Study First Received: December 9, 2009
Last Updated: May 28, 2010
Health Authority: Austria : Federal Ministry for Labour, Health, and Social Affairs

Keywords provided by Medical University of Vienna:
auricular acupuncture
postoperative pain
opioid consumption
laparoscopic surgery
ACUPUNCTURE THERAPY (IM) + EAR, EXTERNAL (IM)

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Pathologic Processes
Postoperative Complications
Signs and Symptoms

ClinicalTrials.gov processed this record on November 20, 2014