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Acupuncture for Pain Control After Ambulatory Knee Arthroscopy (AcuK-Scope)

Primary Purpose

Postoperative Pain; Knee Arthroscopy; Acupuncture

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Acupuncture
Sponsored by
University Medicine Greifswald
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain; Knee Arthroscopy; Acupuncture

Eligibility Criteria

19 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Patients with an American Society of Anesthesiologists physical status of I to II scheduled for elective ambulatory arthroscopic knee surgery under standardized general anesthesia
  2. Surgery time does not exceed 80 minutes
  3. Patients without previous opioid and psychotropic medication
  4. Patients aged between 19 and 55 years, able to fill in the study questionnaire (Appendix F)
  5. Patients who have given written informed consent

Exclusion Criteria:

  1. Current psychiatric disease
  2. Local skin infection at the sites of acupuncture
  3. Aged < 19 or > 55 years
  4. Failure to follow the standardized schema of general anaesthesia
  5. Surgery time more than 80 minutes
  6. Intraoperative complications (bleeding, required blood transfusion more than 6 units of packed cells, cardiovascular instability, required catecholamines)
  7. Patients who consumed opioid medication at least 6 months before surgery
  8. Patients who are unable to understand the consent form or to fill in the study questionnaire.

Sites / Locations

  • University Medicine of GreifswaldRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Acupuncture

No intervention

Arm Description

30 patients will receive acupuncture additionally to standard pharmacological therapy of postoperative pain

30 patients will receive just standard pharmacological therapy of postoperative pain

Outcomes

Primary Outcome Measures

Analgesic requirement
Total dose of ibuprofen taken by the patient during 10 days after arthroscopic knee surgery

Secondary Outcome Measures

Pain intensity: verbal rating scale
Pain intensity measured using verbal rating scale from 0=no pain to 10=maximal pain
Side affects
Incidence of analgesic induced side effects

Full Information

First Posted
October 18, 2019
Last Updated
January 8, 2021
Sponsor
University Medicine Greifswald
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1. Study Identification

Unique Protocol Identification Number
NCT04134702
Brief Title
Acupuncture for Pain Control After Ambulatory Knee Arthroscopy
Acronym
AcuK-Scope
Official Title
Acupuncture vs. Standard Therapy for Treatment of Postoperative Pain in Patients Scheduled for Arthroscopic Knee Surgery - a Pilot Non-randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Medicine Greifswald

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Aim of the study: To investigate whether acupuncture with indwelling fixed needles reduces pain and analgesic requirement and foster mobilization in patients after arthroscopic knee surgery (AKS) Design: Prospective pilot investigation with non-randomized arm Number of patients: N = 60 (30 patients with acupuncture additional to standard pain treatment (SPT) vs. 30 patients with SPT only Inclusion criteria: Adult patients scheduled to elective AKS in general anaesthesia with < 80 min. duration Without previous opioid and psychotropic medication Given informed consentOutcome measures: Postoperative analgesic requirement; Pain intensity; Incidence of side effects; Physiological parameters; Mobilization score

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain; Knee Arthroscopy; Acupuncture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acupuncture
Arm Type
Experimental
Arm Description
30 patients will receive acupuncture additionally to standard pharmacological therapy of postoperative pain
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
30 patients will receive just standard pharmacological therapy of postoperative pain
Intervention Type
Other
Intervention Name(s)
Acupuncture
Intervention Description
Acupuncture and ear acupuncture using indwelling fixed needles, that will remained in situ several days after surgery until the patients will experience pain
Primary Outcome Measure Information:
Title
Analgesic requirement
Description
Total dose of ibuprofen taken by the patient during 10 days after arthroscopic knee surgery
Time Frame
10 days
Secondary Outcome Measure Information:
Title
Pain intensity: verbal rating scale
Description
Pain intensity measured using verbal rating scale from 0=no pain to 10=maximal pain
Time Frame
10 days after surgery
Title
Side affects
Description
Incidence of analgesic induced side effects
Time Frame
10 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients with an American Society of Anesthesiologists physical status of I to II scheduled for elective ambulatory arthroscopic knee surgery under standardized general anesthesia Surgery time does not exceed 80 minutes Patients without previous opioid and psychotropic medication Patients aged between 19 and 55 years, able to fill in the study questionnaire (Appendix F) Patients who have given written informed consent Exclusion Criteria: Current psychiatric disease Local skin infection at the sites of acupuncture Aged < 19 or > 55 years Failure to follow the standardized schema of general anaesthesia Surgery time more than 80 minutes Intraoperative complications (bleeding, required blood transfusion more than 6 units of packed cells, cardiovascular instability, required catecholamines) Patients who consumed opioid medication at least 6 months before surgery Patients who are unable to understand the consent form or to fill in the study questionnaire.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Taras Usichenko, MD, PhD
Phone
00490383486
Ext
5893
Email
taras@uni-greifswald.de
First Name & Middle Initial & Last Name or Official Title & Degree
Joern Lange, MD, PhD
Phone
00490383486
Ext
22579
Email
jnlange@uni-greifswald.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Taras Usichenko, MD, PhD
Organizational Affiliation
Dept. of Anesthesiology
Official's Role
Study Chair
Facility Information:
Facility Name
University Medicine of Greifswald
City
Greifswald
State/Province
Vorpommern
ZIP/Postal Code
17475
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Taras Usichenko, MD. PhD
Phone
00490383486
Ext
5893
Email
taras@uni-greifswald.de

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
On request from study chair after publication of results

Learn more about this trial

Acupuncture for Pain Control After Ambulatory Knee Arthroscopy

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