The Efficacy of Local Infiltration Analgesia for Postoperative Pain Management After Total Knee Arthroplasty

NCT04258241 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2020-11-25

No results posted yet for this study

Summary

This prospective, double-blinded, randomized controlled study evaluates the effects of peripheral nerve blocks with and without local infiltration analgesia for postoperative pain management after primary total knee arthroplasty. There are no any studies that show the demand for local infiltration analgesia when together peripheral nerve blocks are performed. Patients undergoing primary total knee arthroplasty will be randomly assigned to receive local infiltration analgesia with or without (placebo group) local anesthetic. All patients will receive peripheral nerve blocks for postoperative analgesia: femoral triangle and distal adductor canal blocks. Comparison of these two groups of patients will be based on the effects on postoperative pain control, the extent of motor blockade, the ability of early leg motion and ambulation, patients satisfaction rates over the time of clinical recovery.

Consequently, the investigators hypothesized that peripheral nerve blocks (femoral triangle and distal adductor canal blocks) with and without local infiltration analgesia provide similar postoperative pain relieving effects and the ability of early mobilization after total knee arthroplasty.

Conditions

  • Primary Total Knee Arthroplasty

Interventions

PROCEDURE

Local infiltration analgesia with local anesthetic

The orthopedic surgeon will perform local infiltration analgesia at the end of the surgery. The knee joint capsule, periarticular and subcutaneous tissues will be infiltrated with 150 mg of bupivacaine, 0.3 mg of epinephrine and 90 ml of normal saline.

PROCEDURE

Local infiltration analgesia without local anesthetic

The orthopedic surgeon will perform local infiltration analgesia at the end of the surgery. The knee joint capsule, periarticular and subcutaneous tissues will be infiltrated with 0.3 mg of epinephrine and 120 ml of normal saline.

DEVICE

Needle

18-gauge 40 mm Sterican needle (B. Braun Medical Inc., Melsungen, Germany) will be used to perform local infiltration analgesia.

DRUG

Solution with local anesthetic

Solution of 150 mg of bupivacaine, 0.3 mg of epinephrine and 90 ml of normal saline will be used to perform local infiltration analgesia.

DRUG

Solution without local anesthetic

Solution of 0.3 mg of epinephrine and 120 ml of normal saline will be used to perform local infiltration analgesia.

Sponsors & Collaborators

  • Lithuanian University of Health Sciences

    lead OTHER

Principal Investigators

  • Arunas Gelmanas, MDPhDAssProf · Lithuanian University of Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-06
Primary Completion
2021-02-28
Completion
2021-02-28

Countries

  • Lithuania

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04258241 on ClinicalTrials.gov