The Effect of a Prolonged Peripheral Nerve Block on the Level of Pain After a Knee Replacement

NCT ID: NCT06382285

Last Updated: 2024-04-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-30
• Study Completion Date: 2026-01-31

Brief 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

Detailed 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.

Conditions

Knee Replacement Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Treatment group

ropivacaine (Naropin) 0.2% according to a protocol 8-10 cc per hour up to 24 hours after the surgery

Group Type: EXPERIMENTAL

Continues peripheral block

Intervention Type: DRUG

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

Control group

Saline according to a protocol 8-10 cc per hour up to 24 hours after the surgery

Group Type: PLACEBO_COMPARATOR

Continues peripheral block

Intervention Type: DRUG

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

Interventions

Continues peripheral block

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

Intervention Type: DRUG

Other Intervention Names

Treatment group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assaf-Harofeh Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Zoya Haitov Ben Zikri

Director of the anesthesia department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Sara Bar Yehuda, PhD

Role: CONTACT

sarabar1@shamir.gov.il

972528981004

Other Identifiers

0206-22-ASF

Identifier Type: -

Identifier Source: org_study_id