Concentration Effect of Local Anesthetics on Femoral Nerve Block Efficiency

NCT03623230 | Completed Phase 4

• 1 other identifier: DizFemoralKonsant
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

US-guided femoral nerve block is used effectively in post-operative pain management in the surgical treatment of the lower extremity. However, the volume and concentration of the local anesthetic drug to be administered remains controversial. In this prospective, randomized, double-blinded study, patients who underwent unilateral primary total knee arthroplasty and successfully performed spinal anesthesia with standard method and dosage, will be selected for US-guided femoral nerve block after the operation. Patients will be divided into three groups with simple randomization. The First group will be determined as the control group (GCont) and only dressing will be applied to the patients. For second group(G125), 0,125% 20 ml local anesthetic and for the third group (G25), 0,25% 10 ml local anesthetic will be administered to the femoral nerve without changing the drug dose (25 mg bupivacaine). Whether there is a difference between post-op analgesia durations, motor block formation, mobilization time and 90° flexion time between the groups will be investigated.

Conditions

Anesthesia, Conduction; Arthroplasty, Replacement, Knee; Pain, Postoperative; Anesthesia and Analgesia

Keywords

Femoral nerve block; peripheral nerve block; Concentration; volume; bupivacaine; post operative analgesia; total knee arthroplasty

Outcome Measures

Primary Outcomes (7)

• Post-operative pain assessed by Numeric Rating Scale (NRS)

  Pain scores will be recorded as reported by the patient according to NRS

  30th minute postoperatively

• Post-operative pain assessed by Numeric Rating Scale (NRS)

  Pain scores will be recorded as reported by the patient according to NRS

  1st hour postoperatively

• Post-operative pain assessed by Numeric Rating Scale (NRS)

  Pain scores will be recorded as reported by the patient according to NRS

  2nd hour postoperatively

• Post-operative pain assessed by Numeric Rating Scale (NRS)

  Pain scores will be recorded as reported by the patient according to NRS

  6th hour postoperatively

• Post-operative pain assessed by Numeric Rating Scale (NRS)

  Pain scores will be recorded as reported by the patient according to NRS

  12th hour postoperatively

• Post-operative pain assessed by Numeric Rating Scale (NRS)

  Pain scores will be recorded as reported by the patient according to NRS

  24th hour postoperatively

• Post-operative pain assessed by Numeric Rating Scale (NRS)

  Pain scores will be recorded as reported by the patient according to NRS

  48th hour postoperatively

Secondary Outcomes (2)

• Ambulation Time

  72 hours post-operatively

• Opioid Consumption

  48 hour post-operatively

Other Outcomes (1)

• Long Term Infection

  Six months post-operatively

Study Arms (3)

GCont

SHAM COMPARATOR

Only dressing will be applied to patients without actually nerve block performed

Other: Dressing

G125 Block

ACTIVE COMPARATOR

Ultrasound Guided Femoral Nerve Block: 20ml Bupivacaine 0.125% Injectable Solution will be administered for femoral nerve block. 5ml %0,5 Bupivacaine will be diluted with 15ml Saline solution.

Procedure: Ultrasound Guided Femoral Nerve Block; Drug: Bupivacaine 0.125% Injectable Solution

G25 Block

ACTIVE COMPARATOR

Ultrasound Guided Femoral Nerve Block: 10ml Bupivacaine 0.25% Injectable Solution will be administered for femoral nerve block. 5ml %0,5 Bupivacaine will be diluted with 5ml Saline solution.

Procedure: Ultrasound Guided Femoral Nerve Block; Drug: Bupivacaine 0.25% Injectable Solution

Interventions

Ultrasound Guided Femoral Nerve Block PROCEDURE

Femoral nerve block will be applied post-operatively with guidance of USG and nerve stimulator

Also known as: Regional Anesthesia

G125 Block; G25 Block

Dressing OTHER

Only dressing will be applied to related area to protect blindness between groups

GCont

Bupivacaine 0.25% Injectable Solution DRUG

Perineural Injection

Also known as: Marcaine

G25 Block

Bupivacaine 0.125% Injectable Solution DRUG

Perineural Injection

Also known as: Marcain

G125 Block

Eligibility Criteria

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

You may qualify if:

• Patients who are scheduled for primary unilateral total knee arthroplasty under spinal anesthesia
• Patients who has informed consent for study

You may not qualify if:

• Patient's refusal to participate
• Patients under 18 years of age
• Patients who are undergoing surgery with an anesthesia technique other than spinal anesthesia for any reason (general anesthesia, laryngeal mask application, etc.)
• Patients with known local anesthetic allergy
• Patients with Body mass index \> 35
• Patients diagnosed sepsis and bacteriemia,
• Skin infection at the injection site,
• History of coagulopathy or anticoagulant therapy
• Patients with uncontrolled diabetes ,
• Uncoordinated patients,
• Psychological and emotional lability,
• Surgical intervention longer than 3 hours.
• Patients with pre-operative limitation of movement

Sponsors & Collaborators

• Bozyaka Training and Research Hospital: lead

Study Sites (1)

Izmir Bozyaka Training and Research Hospital

Karabağlar, İzmir, 35170, Turkey (Türkiye)

Location

Related Publications (3)

• Karlsen AP, Wetterslev M, Hansen SE, Hansen MS, Mathiesen O, Dahl JB. Postoperative pain treatment after total knee arthroplasty: A systematic review. PLoS One. 2017 Mar 8;12(3):e0173107. doi: 10.1371/journal.pone.0173107. eCollection 2017.

  PMID: 28273133 BACKGROUND

• Tulgar S, Selvi O, Senturk O, Serifsoy TE, Sanel S, Meydaneri S. Evaluation of analgesic regimens in total knee arthroplasty, retrospective study. North Clin Istanb. 2017 Aug 25;4(2):124-130. doi: 10.14744/nci.2017.88598. eCollection 2017.

  PMID: 28971169 BACKGROUND

• Thobhani S, Scalercio L, Elliott CE, Nossaman BD, Thomas LC, Yuratich D, Bland K, Osteen K, Patterson ME. Novel Regional Techniques for Total Knee Arthroplasty Promote Reduced Hospital Length of Stay: An Analysis of 106 Patients. Ochsner J. 2017 Fall;17(3):233-238.

  PMID: 29026354 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Interventions

Anesthesia, Conduction; Bandages; Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia; Equipment and Supplies; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Zeki T TEKGUL, Associate Professor

  Izmir Bozyaka Training and Research Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Three groups involved. One control group and two nerve block groups with different drug concentration

Study Record Dates

• First Submitted: June 30, 2018
• First Posted: August 9, 2018
• Study Start: August 10, 2018
• Primary Completion: December 12, 2018
• Study Completion: February 15, 2019
• Last Updated: July 10, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)