Assessing Function and Pain After Total Knee Arthroplasty With Combined Femoral and Popliteal Nerve Block

NCT06196359 | Completed

• 1 other identifier: UHaifa-FPNB
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this interventional study is to examine whether a pain management technique of combined femoral and popliteal nerve block is effective in total knee arthroplasty patients. The main questions it aims to answer are: Are there differences in postoperative outcomes? Does the nerve block, age, preoperative quadriceps muscle strength and Oxford Knee Score of the patient predict early functional ability? Participants underwent total knee arthroplasty and assessments. Researchers compared pain management techniques to assess effects on postoperative outcomes and identified the importance of preoperative variables a predictors of early functional ability. Further research is required to refine postoperative pain management strategies.

Conditions

Total Knee Arthroplasty; Total Knee Replacement; Total Knee Replacement Surgery; Arthritis Knee; Rehabilitation

Outcome Measures

Primary Outcomes (3)

• Timed up & go Test

  Total time to arise from chair, walk 3 m, turn around, return to chair and sit down. Two trials performed and the faster of the two is recorded to the nearest 10th of a second.

  First day after surgery and third or fourth day after surgery

• Numeric Pain Rating Scale

  An 11-point scale scored from 0 to 10: 0 = no pain, 10= the most intense pain imaginable

  up to four days after surgery

• Quadriceps Muscle Strength

  muscle strength measure by dynamometer (N⋅m)

  A 1 day before the surgery, first day after the surgery and third or fourth day after the surgery .

Secondary Outcomes (7)

• Elderly Mobility Scale

  First day after the surgery and third or fourth day after the surgery

• 5 Times Sit to Stand Test

  First day after the surgery and third or fourth day after the surgery

• Hospitalization Duration

  At discharge (assessed up to day 10)

• Surgery Duration

  During the surgery

• Consumption of Analgesics

  At discharge (assessed up to day 10)

Study Arms (2)

Combined Femoral and Popliteal nerve block

EXPERIMENTAL

Patients who receive a Patients undergoing total knee arthroplasty received a combined femoral and popliteal nerve block (single-shot of each) during the surgical procedure.

Procedure: Combined Femoral and Popliteal nerve block

Control group

NO INTERVENTION

Patients undergoing total knee arthroplasty and didn\'t receive pain block.

Interventions

Combined Femoral and Popliteal nerve block PROCEDURE

Patients who receive a combined femoral and popliteal nerve block during surgery, fill out a questionnaire and undergo a muscle strength test before surgery, undergo functional tests, a muscle strength test and are asked about pain intensity after surgery.

Combined Femoral and Popliteal nerve block

Eligibility Criteria

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

You may qualify if:

• Over the age of 18
• Electively assigned for primary knee replacement surgery.
• The American Society of Anesthesiologists physical status score 1-3.

You may not qualify if:

• Revision surgery.
• Patients suffering from chronic pain syndrome or chronic opioid use.
• Patients with previous neurological deficits in the lower extremities.
• A cognitive state that does not allow signing of consent or understanding simple instructions.

Sponsors & Collaborators

• University of Haifa: lead
• Western Galilee Hospital-Nahariya: collaborator

Study Sites (1)

Galilee Medical Centre

Nahariya, 22000, Israel

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 25, 2023
• First Posted: January 9, 2024
• Study Start: November 1, 2022
• Primary Completion: July 14, 2023
• Study Completion: August 14, 2023
• Last Updated: January 12, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)