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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04286035
Other study ID # SK01
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date April 2, 2019
Est. completion date October 1, 2019

Study information

Verified date March 2020
Source Sisli Hamidiye Etfal Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The frequency of femoral nerve block and adductor canal block for analgesia after TKA(total knee arthroplasty) increases with the use of ultrasonography in regional anesthesia. In this study, we aimed to compare the effects of femoral nerve block and adductor canal block on postoperative analgesia in patients undergoing unilateral knee arthroplasty.


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date October 1, 2019
Est. primary completion date September 29, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 55 Years and older
Eligibility Inclusion Criteria:

- ASA(American Society of Anesthesiologists) Classification I-II

- Age: <55 years

- Unilateral total knee arthroplasty

Exclusion Criteria:

- Does not approve the study

- Pregnant

- Emergency

- ASA III-IV

- History of local anesthetic allergy

- Infection in the block area

- Coagulation disorder

- Morbid obesity (body mass index> 40 kg / m²)

- Severe organ failure

- Previous neurological deficit

- Psychiatric disease

- History of chronic pain

Study Design


Intervention

Drug:
Bupivacaine Injection
Femoral nerve block with 20 ml %0.375 bupivacaine
Bupivacaine Injection
Adductor canal block with 20 ml %0.375 bupivacaine

Locations

Country Name City State
Turkey SBÜ Sisli Hamidiye Etfal Egitim ve Arastirma Hastanesi Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Sisli Hamidiye Etfal Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Tramadol consumption Postoperative tramadol consumption with patient controlled analgesia 24 hours after operation
Primary VAS(visual analogue scale) score (0-10, 0 is no pain, 10 is the most severe pain) VAS(visual analogue scale) score (0-10, 0 is no pain, 10 is the most severe pain) is less than four is adequate analgesia 24 hours after operation
Primary Rescue analgesic requirement If VAS(visual analogue scale) score (0-10, 0 is no pain, 10 is the most severe pain) is is four or more, paracetamol 1000 mg is administered 24 hours after operation
Secondary Postoperative nausea and vomiting Frequency of postoperative nausea and vomiting 24 hours after operation
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