Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
ID06514365

Comparison of the Analgesic Effect of Subsartorial Saphenous Block and Popliteal Sciatic vs Subsartorial Saphenous Block and IPACK in Total Knee Replacement Surgery. A Double Blind Randomized Clinical Trial.

Led by Germans Trias i Pujol Hospital · Updated on 2024-07-23

62

Participants Needed

1

Research Sites

8 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are comparing two types of nerve blocks to manage pain and preserve motor function after total knee replacement surgery. The study focuses on patients with osteoarthritis undergoing this surgery, aiming to evaluate the effectiveness of the subsartorial saphenous block combined with either a sciatic nerve block or an iPACK block. The goal is to understand how these approaches affect pain relief and limb movement post-surgery. Participants receive either an iPACK block or a sciatic nerve block, both using 0.25% bupivacaine with adrenaline, administered once during surgery. The iPACK block targets nerve branches near the back of the knee, while the sciatic block involves a different nerve area. This is a double-blind, randomized trial comparing these two methods to see which provides better pain control and motor function. Participants will be monitored for pain levels at rest and during movement at 6, 24, and 48 hours after surgery, along with assessments of motor block at the same times. Additional measures include opioid use, patient satisfaction, discharge timing, and the ability to walk within 24 hours. The study involves follow-up during the immediate postoperative period to assess these outcomes and support early rehabilitation.

CONDITIONS

Brief Title

Comparison of the Analgesic Effect of Subsartorial Saphenous Block and Popliteal Sciatic vs Subsartorial Saphenous Block and IPACK in Total Knee Replacement Surgery.

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with osteoarthritis scheduled for total primary knee arthroplasty with same surgeons
  • Locoregional anesthesia
  • Age equal to or greater than 18 years
  • Consent to participate in the study
Not Eligible

You will not qualify if you...

  • Age under 18 years old
  • General anesthesia
  • Allergy to local anesthetics
  • Severe kidney failure (Creatinine ≥ 2mg/dL)
  • Chronic opioid use (over 3 months)
  • Chronic pregabalin / gabapentin use (more than 3 months)
  • Psychiatric illness that may interfere with the evaluation or follow-up

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Surgery and Immediate Post-operative Care

Duration - Day of surgery

Participants undergo total knee replacement surgery with either the IPACK block or sciatic nerve block for pain management.

1 visit (in-person)

Post-operative Follow-up

Duration - 48 hours after surgery

Participants are monitored for pain, motor block, opioid use, and recovery up to 48 hours after surgery.

Assessments at 6, 24, and 48 hours after surgery

Trial Site Locations

Total: 1 location

1

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, Spain, 08916

Actively Recruiting

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Research Team

M

Madalina Dinu, Mrs

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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