Department of Anaesthesiology, University of Munich, Germany.
Munich, Bavaria, 80337, Germany
NCT Number: NCT01816386
In the present study, the investigators want to evaluate if press needle acupuncture applied prior to surgery may contribute to the anaesthesiologic outcome. Acupuncture might improve fast-track anaesthesia in the PACU after general surgery.
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Notify Me18 year and older
Female
Interventional
Not applicable
Munich, Bavaria, 80337, Germany
The use of complementary approaches, especially acupuncture, has gained momentum within the last decade. In this regard, it might be appropriate to develop a simply applicable (a) and effective (b) acupuncture regimen for the complementary support of fast-track anaesthesia. Regarding practicability (a), it might be of interest to reduce the amount of necessary acupuncture points. Trials have shown that single-point acupuncture is strong enough to cause relevant clinical effects (Fleckenstein et al., 2009; Lee and Fan, 2009). In addition, practicability means to reduce the amount of needling events; therefore the investigators suggest the use of press needles, making complete peri-anaesthetic availability possible. Regarding effectiveness (b), it has been reported that acupuncture at Governing Vessel 26 (Du-26) may be successful in shock resuscitation (Hsu et al., 2006). In combination with other points it has been evaluated in a Chinese study improving the vegetative state after operation of acute subdural hematoma (Zheng, 2005).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
General Exclusion Criteria:
Exclusion criteria
regarding special restrictions for females:
Indication specific exclusion criteria:
Subjects will not be included in the study if any of the following criteria applies:
Patients in the acupuncture and the acupressure group will receive a standardised treatment comprising 12 SEIRIN® press needles (with a sharp tip) at 7 acupuncture points (Du 26, He 9, Ren 17, bilateral LI 4, He 9, LV 3, Ma 36 and Pe 6). The point regimen is based on consensus process of national and international experts. All needling will be documented by the acupuncturist. Application time is supposed to be 84-96 hours. Modification, especially less points according to the patients reaction during treatment is allowed.
Patients in the acupuncture and the acupressure group will receive a standardised treatment comprising 12 SEIRIN® press plasters (with a blunt knob instead a sharp needle) at 7 acupuncture points (Du 26, He 9, Ren 17, bilateral LI 4, He 9, LV 3, Ma 36 and Pe 6). The point regimen is based on consensus process of national and international experts. All needling will be documented by the acupuncturist. Application time is supposed to be 84-96 hours. Modification, especially less points according to the patients reaction during treatment is allowed.
Time frame: The time from extubation to "Ready for discharge" (in minutes) will followed for the duration in the recovery unit, an expected average of 1 hour
Time from extubation to "Ready for discharge" (in minutes) from the PACU as assessed by the Aldrete score, the Post Anaesthetic Discharge Scoring System (PADSS) and our 'in-house' scoring system when comparing the acupuncture group and the standard treatment group.
Time frame: 2 days, ends when anaesthesia starts
Anxiety (STAI-Score)
Time frame: Patients will be followed for the duration of their stay in the recovery unit, , an expected average of 1 hour
Postoperative pain (pain intensity by VAS)
Time frame: Patients will be followed for the duration of hospital stay follwing the recovery unit, an average of 2 days
Postoperative pain (pain intensity by VAS)
Time frame: Patients will be followed for the duration of the surgical procedure, an expected average of 2 hours
TCI effect concentrations
Time frame: Patients will be followed for the duration of the surgical procedure, an expected average of 2 hours
Organizational time points (e.g. incision to closure time)
Time frame: 3 days
Occurence of acupuncture side effects
Ludwig-Maximilians - University of Munich
Other
Acupuncture Randomized Trial for Post Anaesthetic Recovery and Postoperative Pain - a Pilot Study
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