Clinical trial NCT01816386: Acupuncture Trial for Post Anaesthetic Recovery and Postoperative Pain
Official title: Acupuncture Randomized Trial for Post Anaesthetic Recovery and Postoperative Pain - a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laparoscopic Surgery of Uterus, Adnex or Ovaries
Postoperative Pain
Keywords: acupuncture
anaesthetic recovery
perioperative care
Age 18+
ASA-score ≤ 2
Surgery: Uterus
Surgery: Adnex
Surgery: Ovaries
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
First posted: 2013-03-22
Enrollment: 75
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: The primary objective is the assessment of the effects of permanent needle acupuncture at 12 acupuncture points for improving post anaesthetic recovery.
timeFrame: 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
Secondary outcomes:
measure: Preoperative Variables
timeFrame: 2 days, ends when anaesthesia starts
measure: Variables in PACU
timeFrame: Patients will be followed for the duration of their stay in the recovery unit, , an expected average of 1 hour
measure: Postoperative variables
timeFrame: Patients will be followed for the duration of hospital stay follwing the recovery unit, an average of 2 days
measure: Perioperative Variables
timeFrame: Patients will be followed for the duration of the surgical procedure, an expected average of 2 hours
measure: Perioperative Variables
timeFrame: Patients will be followed for the duration of the surgical procedure, an expected average of 2 hours
Other outcomes:
measure: Safety
timeFrame: 3 days
Locations:
city: Munich
country: Germany
facility: Department of Anaesthesiology, University of Munich, Germany.
state: Bavaria
Study officials:
affiliation: Department of Anaesthesiology, University of Munich
name: Dominik Irnich, PD Dr.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.