Acupuncture Trial for Post Anaesthetic Recovery and Postoperative Pain

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01816386
• Other study ID #: AcuARP
• Status: Completed
• Phase: N/A
• First received: October 28, 2012
• Last updated: January 12, 2015
• Start date: June 2012
• Est. completion date: December 2014

Study information

• Verified date: January 2015
• Source: Ludwig-Maximilians - University of Munich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Regierung von Oberbayern
• Study type: Interventional

Clinical 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: December 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Laparoscopic Surgery of Uterus, Adnex or Ovaries
• Pain, Postoperative
• Postoperative Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
Germany	Department of Anaesthesiology, University of Munich, Germany.	Munich	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Ludwig-Maximilians - University of Munich

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety	Occurence of acupuncture side effects	3 days	Yes
Primary	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	No
Secondary	Preoperative Variables	Anxiety (STAI-Score)	2 days, ends when anaesthesia starts	No
Secondary	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	No
Secondary	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	No
Secondary	Perioperative Variables	TCI effect concentrations	Patients will be followed for the duration of the surgical procedure, an expected average of 2 hours	No
Secondary	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	No