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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acupuncture Regimen | Active Comparator | Standard anaesthetic procedure plus press needle acupuncture |
|
| Standard Treatment Control | No Intervention | Standard anaesthetic procedure plus No treatment. All standardized medication according to the perioperative anaesthetic guideline, Department of Anaesthesiology, University of Munich, will be allowed. In special: According to the guidelines, anxiolysis will be performed intravenously according to the standard guidelines with opioid immediately prior to the induction of anaesthesia. Intraoperative anaesthesia will be performed according to our in-house guidelines: on general recommendations and guidelines of the German society for anaesthesiology (DGAI). Opioids and propofol will be administered via TCI pumps according to the standard protocol. It is allowed to treat the subject for pain with metamizol (4*1.25 g/day) and additional piritramide (PCA; 2 mg each 10 minutes; maximum dosage 30 mg/4 hours) . Variation of this guideline based regimen are allowed if medically indicated. | |
| Acupressure Regimen | Active Comparator | Standard anaesthetic procedure plus press plaster acupressure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture Regimen | Other | Patients in the acupuncture and the acupressure group will receive a standardised treatment comprising 12 SEIRINĀ® 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The primary objective is the assessment of the effects of permanent needle acupuncture at 12 acupuncture points for improving post anaesthetic recovery. | 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Preoperative Variables | Anxiety (STAI-Score) | 2 days, ends when anaesthesia starts |
| Variables in PACU | Postoperative pain (pain intensity by VAS) |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | Occurence of acupuncture side effects | 3 days |
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:
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| Name | Affiliation | Role |
|---|---|---|
| Dominik Irnich, PD Dr. | Department of Anaesthesiology, University of Munich | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anaesthesiology, University of Munich, Germany. | Munich | Bavaria | 80337 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23394517 | Background | Fleckenstein J, Sittl R, Averbeck B, Lang PM, Irnich D, Carr RW. Activation of axonal Kv7 channels in human peripheral nerve by flupirtine but not placebo - therapeutic potential for peripheral neuropathies: results of a randomised controlled trial. J Transl Med. 2013 Feb 8;11:34. doi: 10.1186/1479-5876-11-34. | |
| 25047046 | Derived |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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|
| Acupressure Regimen | Other | Patients in the acupuncture and the acupressure group will receive a standardised treatment comprising 12 SEIRINĀ® 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. |
|
| Patients will be followed for the duration of their stay in the recovery unit, , an expected average of 1 hour |
| Postoperative variables | Postoperative pain (pain intensity by VAS) | Patients will be followed for the duration of hospital stay follwing the recovery unit, an average of 2 days |
| Perioperative Variables | TCI effect concentrations | Patients will be followed for the duration of the surgical procedure, an expected average of 2 hours |
| Perioperative Variables | Organizational time points (e.g. incision to closure time) | Patients will be followed for the duration of the surgical procedure, an expected average of 2 hours |
| Fleckenstein J, Baeumler PI, Gurschler C, Weissenbacher T, Simang M, Annecke T, Geisenberger T, Irnich D. Acupuncture for post anaesthetic recovery and postoperative pain: study protocol for a randomised controlled trial. Trials. 2014 Jul 21;15:292. doi: 10.1186/1745-6215-15-292. |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |