Description 7 acupuncture points (Du 26 and Ren 17 (on the middle body line), and bilateral LI 4, HE 7, LV 3, ST 36 and PC 6; see Figure 2)
Experimental Description
We will compare (a) press needle acupuncture, (b) no treatment and (c) press plaster acupressure in a standardised anaesthetic setting. In this trial we will use acupressure (group C) as an intervention to compare acupuncture (group A). Patients and examiners will be blinded for the patients' assignment to treatment arms A and C. Therefore, we use press needles (0.2 mm x 1.5 mm; Seirin New Pyonex , Seirin Corp., Shizuoka City, Japan) in group A and non-invasive Seirin press plasters in group C - a device that has successfully been validated for blinding in acupuncture trials.
Sample Count
75
Age
＞18
Control
Blank
Placebo
no treatment(group B)(n=25);press plaster acupressure(group C)(n=25)
Experiment
press needle acupuncture(group A)(n=25)
Indicator
Aldrete scorePost Anaesthetic Discharge Scoring SystemAn In-House scoreAnxietyPainPostoperative Nausea and Vomiting(PONV)Concomitant medicationVital signsPain intensityConsumption of analgesicsSedative drugs doseBispectral index(BIS)Shivering
Auxiliary Medication
To avoid postoperative pain all patients receive metamizol 2.5 g iv-infusions and to prevent PONV they receive dexamethasone 8 mg iv and for prevention of gastric stress ulcer they receive ranitidine 50 mg iv during surgery. Postoperatively, subjects are treated for pain with metamizol (4 x 1.25 g/day) and the opioid piritramide (PCA; 2 mg each 10 minutes; maximum dosage 30 mg/4 hours). In case of nausea and vomiting or shivering, patients are treated according to the clinical standard.
Stimulation Method
MS
Induction Method
Electroacupuncture Instrument Model
Manufacturer
Frequency
Waveform
Strength
Induction Time
-
-
-
-
-
at least three times a day, each time at a minimum of four different points, each for about 30 seconds.
Acupuncture_Needle
Needle_Manufacturer
Needle_Depth
0.2×1.5 mm
Seirin Co. Ltd, Shizuoka City, Japan
-
Description Stimulation of the press needles or press plasters has to be done at least three times a day, each time at a minimum of four different points, each for about 30 seconds.
Anesthesia Method
AAA
Clinical Trial Type
a randomised controlled pilot trial with three arms and partial double blinding
Effector
The results of this study will provide information on whether acupuncture may improve patient post anaesthetic recovery. Comparing acupuncture with acupressure will provide insight into potential therapeutic differences between invasive and non-invasive acupuncture techniques.
Acupuncture for post anaesthetic recovery and postoperative pain: study protocol for a randomised controlled trial.
Abstract
BACKGROUND: We report on the design and implementation of a study protocol entitled Acupuncture randomised trial for post anaesthetic recovery and postoperative pain - a pilot study (ACUARP) designed to investigate the effectiveness of acupuncture therapy performed in the perioperative period on post anaesthetic recovery and postoperative pain. METHODS/DESIGN: The study is designed as a randomised controlled pilot trial with three arms and partial double blinding. We will compare (a) press needle acupuncture, (b) no treatment and (c) press plaster acupressure in a standardised anaesthetic setting. Seventy-five patients scheduled for laparoscopic surgery to the uterus or ovaries will be allocated randomly to one of the three trial arms. The total observation period will begin one day before surgery and end on the second postoperative day. Twelve press needles and press plasters are to be administered preoperatively at seven acupuncture points. The primary outcome measure will be time from extubation to 'ready for discharge' from the post anaesthesia care unit (in minutes). The 'ready for discharge' end point will be assessed using three different scores: the Aldrete score, the Post Anaesthetic Discharge Scoring System and an In-House score. Secondary outcome measures will comprise pre-, intra- and postoperative variables (which are anxiety, pain, nausea and vomiting, concomitant medication). DISCUSSION: The results of this study will provide information on whether acupuncture may improve patient post anaesthetic recovery. Comparing acupuncture with acupressure will provide insight into potential therapeutic differences between invasive and non-invasive acupuncture techniques. TRIAL REGISTRATION: NCT01816386 (First received: 28 October 2012)."
