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

NCT04258241 | Unknown DMC

• 1 other identifier: BEC-MF-36
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Local infiltration analgesia; Primary knee arthroplasty; Postoperative pain management; Postoperative recovery; Adductor canal block; Femoral triangle block

Outcome Measures

Primary Outcomes (1)

• Changes in postoperative pain intensity and pain control: VAS pain scale

  Postoperative pain will be assessed in both groups using the visual analogue scale (VAS). The VAS pain scale (numerical rating scale) consists of a range from 0 (no pain) to 10 (worst imaginable pain). Higher score indicate greater pain intensity. Interpretation: 0 (no pain); 1-3 (mild pain); 4-6 (moderate pain); 7-10 (severe pain). Pain control will be assessed at rest, during active and passive 45 degree knee flexion at 3, 6, 24, 48 hours after the surgery.

  First 48 hours after primary total knee arthroplasty.

Secondary Outcomes (5)

• Extent of motor blockade.

  First 48 hours after primary total knee arthroplasty.

• Postoperative ability of early ambulation.

  First 48 hours after primary total knee arthroplasty.

• Opioid consumption.

  First 48 hours after primary total knee arthroplasty.

• Rate of patients satisfaction: 10 point scale

  First 48 hours after primary total knee arthroplasty.

• Number of participants with postoperative complications.

  First 48 hours after primary total knee arthroplasty.

Study Arms (2)

Local infiltration analgesia with local anesthetic (LIA+)

ACTIVE COMPARATOR

Local infiltration analgesia will be performed at the end of the surgery by injection of 150 mg of bupivacaine, 0.3 mg of epinephrine and 90 ml of normal saline.

Procedure: Local infiltration analgesia with local anesthetic; Device: Needle; Drug: Solution with local anesthetic

Local infiltration analgesia without local anesthetic (LIA-)

PLACEBO COMPARATOR

Local infiltration analgesia will be performed at the end of the surgery by injection of 0.3 mg of epinephrine and 120 ml of normal saline.

Procedure: Local infiltration analgesia without local anesthetic; Device: Needle; Drug: Solution without local anesthetic

Interventions

Local infiltration analgesia with local anesthetic PROCEDURE

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.

Local infiltration analgesia with local anesthetic (LIA+)

Local infiltration analgesia without local anesthetic PROCEDURE

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.

Local infiltration analgesia without local anesthetic (LIA-)

Needle DEVICE

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

Local infiltration analgesia with local anesthetic (LIA+); Local infiltration analgesia without local anesthetic (LIA-)

Solution with local anesthetic DRUG

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.

Also known as: Containing bupivacaine

Local infiltration analgesia with local anesthetic (LIA+)

Solution without local anesthetic DRUG

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

Also known as: Without bupivacaine

Local infiltration analgesia without local anesthetic (LIA-)

Eligibility Criteria

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

You may qualify if:

• Patients undergoing primary unilateral total knee arthroplasty under spinal anaesthesia;
• Age 18 - 90 years;
• Patients conformed to American Society of Anaesthesiologists (ASA) physical status I-III in preoperative assessment;
• Ability to follow the study protocol.

You may not qualify if:

• Inability or refusal to follow the study protocol.
• American Society of Anesthesiologists (ASA) physical status classification of IV or higher.
• Coagulopathy.
• Pre-exiting lower extremity neuromuscular disorders.
• Local infection over injection site.
• Allergy or contraindications to the drugs used in the study (local anesthetics, NSAIDs, opioids).
• Chronic opioid use.
• Other type of anesthesia.

Sponsors & Collaborators

• Lithuanian University of Health Sciences: lead

Study Sites (1)

Lithuanian University of Health Sciences Kauno Klinikos, Department of Anesthesiology

Kaunas, Lithuania

RECRUITING

Related Publications (4)

• Mont MA, Beaver WB, Dysart SH, Barrington JW, Del Gaizo DJ. Local Infiltration Analgesia With Liposomal Bupivacaine Improves Pain Scores and Reduces Opioid Use After Total Knee Arthroplasty: Results of a Randomized Controlled Trial. J Arthroplasty. 2018 Jan;33(1):90-96. doi: 10.1016/j.arth.2017.07.024. Epub 2017 Jul 25.

  PMID: 28802777 BACKGROUND

• Andersen LO, Kehlet H. Analgesic efficacy of local infiltration analgesia in hip and knee arthroplasty: a systematic review. Br J Anaesth. 2014 Sep;113(3):360-74. doi: 10.1093/bja/aeu155. Epub 2014 Jun 17.

  PMID: 24939863 BACKGROUND

• Beswick AD, Dennis J, Gooberman-Hill R, Blom AW, Wylde V. Are perioperative interventions effective in preventing chronic pain after primary total knee replacement? A systematic review. BMJ Open. 2019 Sep 6;9(9):e028093. doi: 10.1136/bmjopen-2018-028093.

  PMID: 31494601 BACKGROUND

• Bendtsen TF, Moriggl B, Chan V, Borglum J. The Optimal Analgesic Block for Total Knee Arthroplasty. Reg Anesth Pain Med. 2016 Nov/Dec;41(6):711-719. doi: 10.1097/AAP.0000000000000485.

  PMID: 27685346 BACKGROUND

MeSH Terms

Interventions

Anesthetics, Local; Needles; Solutions; Bupivacaine

Intervention Hierarchy (Ancestors)

Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses; Equipment and Supplies; Pharmaceutical Preparations; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Arunas Gelmanas, MDPhDAssProf

  Lithuanian University of Health Sciences

  STUDY CHAIR

Central Study Contacts

Arunas Gelmanas, MDPhDAssProf

CONTACT

+37068046865; arunas.gelmanas@kaunoklinikos.lt

Inna Jaremko, MD

CONTACT

+37064857386; inna.jaremko@kaunoklinikos.lt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 4, 2020
• First Posted: February 6, 2020
• Study Start: March 6, 2020
• Primary Completion: February 1, 2021
• Study Completion: February 1, 2021
• Last Updated: November 25, 2020

Record last verified: 2020-11

Locations

LI (1)