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

NCT06382285 | Not Yet Recruiting

• 1 other identifier: 0206-22-ASF
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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

Conditions

Knee Replacement Surgery

Outcome Measures

Primary Outcomes (2)

• Pain level

  Documentation of pain level during the hospitalization days every 12 hours (on a scale of 1-10)

  during hospitalization (1-2 days)

• 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 Outcomes (1)

• Physiotherapy

  during hospitalization (1-2 days)

Study Arms (2)

Treatment group

EXPERIMENTAL

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

Drug: Continues peripheral block

Control group

PLACEBO COMPARATOR

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

Drug: Continues peripheral block

Interventions

Continues peripheral block DRUG

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

Also known as: Treatment group

Control group; Treatment group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients with sensitivity to the anesthetic.

Sponsors & Collaborators

• Assaf-Harofeh Medical Center: lead

Central Study Contacts

Sara Bar Yehuda, PhD

CONTACT

972528981004; sarabar1@shamir.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the anesthesia department

Model Details: The study will include 50 patients who underwent a knee replacement surgery, who will be randomized to 2 groups. 6 hours after surgery the two groups will be connected to a prolonged block pump. One group will receive the peripheral block ropivacaine 0.2% according to the protocol of 8-10 cc per hour up to 24 hours after surgery. The second group will receive saline according to the same protocol

Study Record Dates

• First Submitted: September 7, 2023
• First Posted: April 24, 2024
• Study Start: October 30, 2024
• Primary Completion: October 30, 2025
• Study Completion: January 31, 2026
• Last Updated: April 24, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share