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NCT Number: NCT01816386

Acupuncture Trial for Post Anaesthetic Recovery and Postoperative Pain

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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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anaesthesiology, University of Munich, Germany.

Munich, Bavaria, 80337, Germany

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acupuncture Regimen

Other

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.

Acupressure Regimen

Other

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.

Primary outcomes

  1. The primary objective is the assessment of the effects of permanent needle acupuncture at 12 acupuncture points for improving post anaesthetic recovery.

    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.

Secondary outcomes

  1. Preoperative Variables

    Time frame: 2 days, ends when anaesthesia starts

    Anxiety (STAI-Score)

  2. Variables in PACU

    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)

  3. Postoperative variables

    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)

  4. Perioperative Variables

    Time frame: Patients will be followed for the duration of the surgical procedure, an expected average of 2 hours

    TCI effect concentrations

  5. Perioperative Variables

    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)

Other outcomes

  1. Safety

    Time frame: 3 days

    Occurence of acupuncture side effects

Sponsors and collaborators

Lead sponsor

Ludwig-Maximilians - University of Munich

Other

Registry information

Official study title

Acupuncture Randomized Trial for Post Anaesthetic Recovery and Postoperative Pain - a Pilot Study

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Mar 22, 2013
Registry last updated
Jan 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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