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Acupuncture Trial for Post Anaesthetic Recovery and Postoperative Pain

Primary Purpose

Laparoscopic Surgery of Uterus, Adnex or Ovaries, Postoperative Pain

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Acupuncture Regimen

Acupressure Regimen

About this trial

This is an interventional treatment trial for Laparoscopic Surgery of Uterus, Adnex or Ovaries focused on measuring acupuncture, anaesthetic recovery, perioperative care, Age 18+, ASA-score ≤ 2, Surgery: Uterus, Surgery: Adnex, Surgery: Ovaries

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

Department of Anaesthesiology, University of Munich, Germany.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

No Intervention

Active Comparator

Arm Label

Acupuncture Regimen

Standard Treatment Control

Acupressure Regimen

Arm Description

Standard anaesthetic procedure plus press needle acupuncture

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.

Standard anaesthetic procedure plus press plaster acupressure

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Preoperative Variables

Anxiety (STAI-Score)

Variables in PACU

Postoperative pain (pain intensity by VAS)

Postoperative variables

Postoperative pain (pain intensity by VAS)

Perioperative Variables

TCI effect concentrations

Perioperative Variables

Organizational time points (e.g. incision to closure time)

Full Information

NCT ID

NCT01816386

First Posted

October 28, 2012

Last Updated

January 12, 2015

Sponsor

Ludwig-Maximilians - University of Munich

1. Study Identification

Unique Protocol Identification Number

NCT01816386

Brief Title

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

2. Study Status

Record Verification Date

January 2015

Overall Recruitment Status

Completed

Study Start Date

June 2012 (undefined)

Primary Completion Date

June 2014 (Actual)

Study Completion Date

December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ludwig-Maximilians - University of Munich

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

75 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Acupuncture Regimen

Arm Type

Active Comparator

Arm Description

Standard anaesthetic procedure plus press needle acupuncture

Arm Title

Standard Treatment Control

Arm Type

No Intervention

Arm Description

Arm Title

Acupressure Regimen

Arm Type

Active Comparator

Arm Description

Standard anaesthetic procedure plus press plaster acupressure

Intervention Type

Other

Intervention Name(s)

Acupuncture Regimen

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Acupressure Regimen

Intervention Description

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 Outcome Measure Information:

Title

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

Description

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

Secondary Outcome Measure Information:

Title

Preoperative Variables

Description

Anxiety (STAI-Score)

Time Frame

2 days, ends when anaesthesia starts

Title

Variables in PACU

Description

Postoperative pain (pain intensity by VAS)

Time Frame

Patients will be followed for the duration of their stay in the recovery unit, , an expected average of 1 hour

Title

Postoperative variables

Description

Postoperative pain (pain intensity by VAS)

Time Frame

Patients will be followed for the duration of hospital stay follwing the recovery unit, an average of 2 days

Title

Perioperative Variables

Description

TCI effect concentrations

Time Frame

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

Title

Perioperative Variables

Description

Organizational time points (e.g. incision to closure time)

Time Frame

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

Other Pre-specified Outcome Measures:

Title

Safety

Description

Occurence of acupuncture side effects

Time Frame

3 days

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dominik Irnich, PD Dr.

Organizational Affiliation

Department of Anaesthesiology, University of Munich

Official's Role

Study Director

Facility Information:

Facility Name

Department of Anaesthesiology, University of Munich, Germany.

City

Munich

State/Province

Bavaria

ZIP/Postal Code

80337

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

23394517

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.

Results Reference

background

PubMed Identifier

25047046

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.

Results Reference

derived

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Acupuncture Trial for Post Anaesthetic Recovery and Postoperative Pain

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