Laparoscopic Surgery of Uterus, Adnex or OvariesNCT01816386

Acupuncture Trial for Post Anaesthetic Recovery and Postoperative Pain

A study testing Acupuncture Regimen and Acupressure Regimen in people with Laparoscopic Surgery of Uterus, Adnex or Ovaries and Postoperative Pain, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Laparoscopic Surgery of Uterus, Adnex or Ovaries, Postoperative Pain
What is being tested?: Acupuncture Regimen and Acupressure Regimen
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 75 participants
Where: 1 siteGermany
Study dates: Jun 2012to Dec 2014
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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:

Show all 15Show fewer

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 locations and contacts

1 site in 1 country.

Germany1 site

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

Other trials in Germany

About this study

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

Read the 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).

Conditions: Laparoscopic Surgery of Uterus, Adnex or Ovaries, Postoperative Pain
Being tested: Acupuncture Regimen, Acupressure Regimen
Keywords: acupuncture, anaesthetic recovery, perioperative care, Age 18+, ASA-score ≤ 2, Surgery: Uterus, Surgery: Adnex, Surgery: Ovaries
Medical subject headings: Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Acupuncture RegimenOther
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 RegimenOther
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.

Study groups in NCT01816386
Study group	Role	What they receive
Acupuncture Regimen	Active comparator	Standard anaesthetic procedure plus press needle acupuncture Receives: Other: Acupuncture Regimen
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 Receives: Other: Acupressure Regimen

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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 (5)

Preoperative Variables
Anxiety (STAI-Score)
Measured: 2 days, ends when anaesthesia starts
Variables in PACU
Postoperative pain (pain intensity by VAS)
Measured: 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)
Measured: Patients will be followed for the duration of hospital stay follwing the recovery unit, an average of 2 days
Perioperative Variables
TCI effect concentrations
Measured: 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)
Measured: Patients will be followed for the duration of the surgical procedure, an expected average of 2 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2012Dec 2014

First posted22 Mar 2013 (estimated)
Study startJun 2012
Primary completionJun 2014
Study completionDec 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Laparoscopic Surgery of Uterus, Adnex or OvariesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Outcomes assessor
Enrolment: 75 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01816386
Sponsor's protocol ID: AcuARP
Status last verified: Jan 2015
First submitted: 28 Oct 2012
Last updated: 13 Jan 2015
Results posted: No
Data monitoring committee: No

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.
PubMed 23394517
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.
PubMed 25047046

Study at a glance

From the registry record, last updated by the sponsor on 13 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Acupuncture Randomized Trial for Post Anaesthetic Recovery and Postoperative Pain - a Pilot Study
ClinicalTrials.gov ID: NCT01816386
Acronym / sponsor ID: AcuARP
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
Study type: Interventional
Recruitment status: Completed
Enrolment: 75 participants (actual)
Lead sponsor: Ludwig-Maximilians - University of MunichUniversity, hospital or other
Study start: Jun 2012
Primary completion: Jun 2014 (actual)
Study completion: Dec 2014 (actual)
First posted: 22 Mar 2013 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Acupuncture Regimen	Active comparator	Other: Acupuncture RegimenStandard 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	Other: Acupressure RegimenStandard anaesthetic procedure plus press plaster acupressure

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (15 listed)

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
Current or planned pregnancy or nursing women

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Acupuncture RegimenPatients 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.	Other	Acupuncture Regimen
Acupressure RegimenPatients 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.	Other	Acupressure Regimen

Primary outcome

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.

5 secondary outcomes

Preoperative Variables
Time frame: 2 days, ends when anaesthesia starts
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 variables
Time frame: Patients will be followed for the duration of hospital stay follwing the recovery unit, an average of 2 days
Perioperative Variables
Time frame: Patients will be followed for the duration of the surgical procedure, an expected average of 2 hours
Perioperative Variables
Time frame: Patients will be followed for the duration of the surgical procedure, an expected average of 2 hours

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2015.
Background: PubMed 23394517Fleckenstein 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.
Derived from this study: PubMed 25047046Fleckenstein 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.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Dominik Irnich, PD Dr. study director

Department of Anaesthesiology, University of Munich

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01816386, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2015.