Acupuncture Trial for Post Anaesthetic Recovery and Postoperative Pain

NCT ID: NCT01816386

Last Updated: 2015-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2014-12-31

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).

Conditions

Laparoscopic Surgery of Uterus, Adnex or Ovaries; Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Acupuncture Regimen

Standard anaesthetic procedure plus press needle acupuncture

Group Type: ACTIVE_COMPARATOR

Acupuncture Regimen

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Acupressure Regimen

Standard anaesthetic procedure plus press plaster acupressure

Group Type: ACTIVE_COMPARATOR

Acupressure Regimen

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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

• 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
• 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.

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ludwig-Maximilians - University of Munich

OTHER

Sponsor Role: lead

Responsible Party

Dr. Johannes Fleckenstein

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dominik Irnich, PD Dr.

Role: STUDY_DIRECTOR

Department of Anaesthesiology, University of Munich

Locations

Department of Anaesthesiology, University of Munich, Germany.

Munich, Bavaria, Germany

Countries

Germany

References

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.

Reference Type: BACKGROUND

PMID: 23394517 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 25047046 (View on PubMed)

Other Identifiers

AcuARP

Identifier Type: -

Identifier Source: org_study_id