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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06382285
Other study ID # 0206-22-ASF
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 30, 2024
Est. completion date January 31, 2026

Study information

Verified date April 2024
Source Assaf-Harofeh Medical Center
Contact Sara Bar Yehuda, PhD
Phone 972528981004
Email sarabar1@shamir.gov.il
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to examine the effect of a prolonged peripheral nerve block (utilizing continuous adductor canal block) on the level of pain after a knee replacement surgery


Description:

Knee replacement surgery is one of the common orthopedic surgeries for the treatment of chronic knee pain. The period after knee replacement surgery is accompanied by moderate to severe pain that affects the patient's ability to quickly return to function. Peripheral nerve blockers and analgesia of different types, administered as part of the anesthesia process, are optimal in controlling pain after surgery. After the surgery, the patients are admitted in the orthopedic inpatient department for 2-3 days on average after surgery for follow-up and early physical therapy necessary to achieve good results and return the patient to full function as soon as possible. The level of pain greatly affects the success rate of the patient's rehabilitation. Thus, since the duration of peripheral nerve block activity does not exceed 8-16 hours on average, it is suggested to treat the patients with a prolonged peripheral nerve block (utilizing continuous adductor canal block) for 24 hours after surgery.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date January 31, 2026
Est. primary completion date October 30, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Female and male patients between the ages of 18 and 80 who have signed an informed consent form. - ASA is less than 3 - Spinal anesthesia Exclusion Criteria: - Patients with sensitivity to the anesthetic.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Continues peripheral block
ropivacaine (Naropin) 0.2% according to a protocol 8-10 cc per hour up to 24 hours after surgery

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assaf-Harofeh Medical Center

Outcome

Type Measure Description Time frame Safety issue
Primary Pain level Documentation of pain level during the hospitalization days every 12 hours (on a scale of 1-10) during hospitalization (1-2 days)
Primary Analgesic use Documentation of pain level during the hospitalization days every 12 hours (on a scale of 1-10).
Documentation of analgesic administration in hospitalization.
during hospitalization (1-2 days)
Secondary Physiotherapy Documentation of the execution of a full or partial physical therapy program during hospitalization (1-2 days)
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