Acupuncture for Pain Control After Ambulatory Knee Arthroscopy

NCT ID: NCT04134702

Last Updated: 2021-01-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-01
• Study Completion Date: 2022-12-31

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

Conditions

Postoperative Pain; Knee Arthroscopy; Acupuncture

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Acupuncture

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

Group Type: EXPERIMENTAL

Acupuncture

Intervention Type: OTHER

Acupuncture and ear acupuncture using indwelling fixed needles, that will remained in situ several days after surgery until the patients will experience pain

No intervention

30 patients will receive just standard pharmacological therapy of postoperative pain

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Acupuncture

Acupuncture and ear acupuncture using indwelling fixed needles, that will remained in situ several days after surgery until the patients will experience pain

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Medicine Greifswald

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Taras Usichenko, MD, PhD

Role: STUDY_CHAIR

Dept. of Anesthesiology

Locations

University Medicine of Greifswald

Greifswald, Vorpommern, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Taras Usichenko, MD, PhD

Role: CONTACT

taras@uni-greifswald.de

00490383486 ext. 5893

Joern Lange, MD, PhD

Role: CONTACT

jnlange@uni-greifswald.de

00490383486 ext. 22579

Facility Contacts

Taras Usichenko, MD. PhD

Role: primary

taras@uni-greifswald.de

00490383486 ext. 5893

Other Identifiers

BB 079/18

Identifier Type: -

Identifier Source: org_study_id