Acupuncture Trial for Post Anaesthetic Recovery and Postoperative Pain

Ludwig Maximilian University of Munich

Status: Completed

Conditions: Postoperative Pain; Laparoscopic Surgery of Uterus, Adnex or Ovaries

Treatments: Other: Acupuncture Regimen; Other: Acupressure Regimen

Study type: Interventional

Funder types: Other

Identifiers

NCT01816386

AcuARP

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 75 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18+
• Scheduled for laparoscopic surgery of uterus, adnex or ovaries
• ASA-score ≤ 2
• Subjects with the ability to follow study instructions and likely to attend and complete all required visits
• Written informed consent of the subject

Exclusion criteria

General Exclusion Criteria:

• Subject without legal capacity who is unable to understand the nature, scope, significance and consequences of this clinical trial
• Simultaneously participation in another clinical trial or participation in any clinical trial involving administration of acupuncture within 30 days prior to clinical trial beginning
• Subjects with a physical or psychiatric condition which at the investigator's discretion may put the subject at risk, may confound the trial results, or may interfere with the subject's participation in this clinical trial
• Known or persistent abuse of medication, drugs or alcohol

Exclusion criteria regarding special restrictions for females:

• Current or planned pregnancy or nursing women
• Females of childbearing potential, who are not using and not willing to use medically reliable methods of contraception for the entire study duration (such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices) unless they are surgically sterilized / hysterectomized or there are any other criteria considered sufficiently reliable by the investigator in individual cases.

Indication specific exclusion criteria:

Subjects will not be included in the study if any of the following criteria applies:

• Surgery within the last three months
• Chronic pain > 3 month
• Continuous analgesic medication with opioids longer than 3 days
• Massive degenerative diseases
• Pre-treatment with acupuncture or trigger point injection within the last 2 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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75 participants in 3 patient groups

Acupuncture Regimen

Active Comparator group

Description:

Standard anaesthetic procedure plus press needle acupuncture

Treatment:

Other: Acupuncture Regimen

Standard Treatment Control

No Intervention group

Description:

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 group

Description:

Standard anaesthetic procedure plus press plaster acupressure

Treatment:

Other: Acupressure Regimen