Acupuncture Trial for Post Anaesthetic Recovery and Postoperative Pain

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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Laparoscopic Surgery of Uterus, Adnex or Ovaries
• Intervention / Treatment: Other: Acupuncture Regimen; Other: Acupressure Regimen

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).

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bavaria
    • Munich, Bavaria, Germany, 80337
      • Department of Anaesthesiology, University of Munich, Germany.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Acupuncture Regimen; Standard anaesthetic procedure plus press needle acupuncture	Other: Acupuncture Regimen; 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.
No Intervention: Standard Treatment Control; 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.
Active Comparator: Acupressure Regimen; Standard anaesthetic procedure plus press plaster acupressure	Other: Acupressure Regimen; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preoperative Variables	Anxiety (STAI-Score)	2 days, ends when anaesthesia starts
Variables in PACU	Postoperative pain (pain intensity by VAS)	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety	Occurence of acupuncture side effects	3 days

Collaborators and Investigators

• Sponsor: Ludwig-Maximilians - University of Munich
• Investigators: Study Director: Dominik Irnich, PD Dr., Department of Anaesthesiology, University of Munich

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: October 28, 2012
• First Submitted That Met QC Criteria: March 21, 2013
• First Posted (Estimate): March 22, 2013

Study Record Updates

• Last Update Posted (Estimate): January 13, 2015
• Last Update Submitted That Met QC Criteria: January 12, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: acupuncture; perioperative care; anaesthetic recovery; Age 18+; ASA-score ≤ 2; Surgery: Uterus; Surgery: Adnex; Surgery: Ovaries
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: AcuARP