Auricular Acupuncture in Postoperative Pain

NCT01030029 | Completed Phase 4 DMC

• 2 other identifiers: 08/2009262/2005
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Acupuncture

Keywords

auricular acupuncture; postoperative pain; opioid consumption; laparoscopic surgery; ACUPUNCTURE THERAPY (IM) + EAR, EXTERNAL (IM)

Outcome Measures

Primary Outcomes (1)

• mean postoperative pain (VAS score)

  0,2,24,48,72 hours

Secondary Outcomes (1)

• consumption of piritramide postoperatively

  0,2,24,48,72 hours postoperatively

Study Arms (2)

electrical auricular acupuncture

ACTIVE COMPARATOR

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

pstim device without acupuncture

PLACEBO COMPARATOR

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.

Interventions

electrical auricular acupuncture DEVICE

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.

Also known as: P-Stim® The stimulator consists of a microcontroller and a bit-coded ST62T60BM6 interface, which produce defined waves of electrical stimuli

electrical auricular acupuncture

P-Stim™ devices were applied without electrical stimulation and acupuncture. DEVICE

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

pstim device without acupuncture

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Vienna: lead
• Department of Anesthesiology, General Intensive Care Medicine and Pain Control: collaborator

Study Sites (1)

Medical University Vienna

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Electric Stimulation; Acupuncture Therapy

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Stimulation; Investigative Techniques; Complementary Therapies; Therapeutics

Study Officials

• Andrea Holzer, MD

  Medical University Vienna, Department of Anesthesiology and General Intensive Care Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 9, 2009
• First Posted: December 10, 2009
• Study Start: January 1, 2006
• Primary Completion: December 1, 2007
• Study Completion: February 1, 2008
• Last Updated: April 8, 2015

Record last verified: 2006-01

Locations

AU (1)