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Concentration Effect of Local Anesthetics on Femoral Nerve Block Efficiency

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03623230
Recruitment Status : Completed
First Posted : August 9, 2018
Last Update Posted : July 10, 2019
Sponsor:
Information provided by (Responsible Party):
Bozyaka Training and Research Hospital

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.

Condition or disease Intervention/treatment Phase
Anesthesia, Conduction Arthroplasty, Replacement, Knee Pain, Postoperative Anesthesia and Analgesia Procedure: Ultrasound Guided Femoral Nerve Block Other: Dressing Drug: Bupivacaine 0.25% Injectable Solution Drug: Bupivacaine 0.125% Injectable Solution Phase 4

Detailed Description:

All patients scheduled for total knee arthroplasty will be evaluated before the operation. Eligible patients will be informed about the study and "Numeric Rating Scale" for pain evaluation. Then, patients will be asked for informed consent. After approval from the local research ethics committee, first patient will be recruited for study and patient's group will be determined by dice roll(1,4: GCont - 2,5: G125 - 3,6: G25). Patients who are scheduled for primary total knee arthroplasty under spinal anesthesia with a planned sensory block level between T4 and T7 dermatomes, will be recruited and assigned to a group. After successfully completed surgery, patients will be administered femoral nerve block or only dressing according to the relevant group. Before femoral nerve block is performed, patients will be re-informed about Numeric Rating Scale(NRS) and will be asked to rate their pain at the moment.

  • Control Group(GCont) patients will only be applied sterile dressing for the purpose of blinding the patient and the follow-up physician.
  • 0.125% Bupivacaine Group(G125) patients will be administered femoral block with 20 ml 0.125% Bupivacaine by an experienced anesthesiologist.
  • 0.25% Bupivacaine Group(G25) patients 10ml will be administered femoral block with 0.25% Bupivacaine by an experienced anesthesiologist.

The procedures will be performed in the operating room under both US and nerve stimulator guidance. Patients will be followed-up in post-anesthesia care unit and in the ward for 48 hours. Scheduled and on-demand(Tramadol) medication for analgesia will be ordered and nurses will be informed about the study. Patients' pain scores and ambulation times will be followed-up by another anesthesiologist and on-demand medication will be recorded and monitored from hospital's computer based hospital management program online. Patients will be followed-up for six months after the surgery in order to explore potential long term benefits and complications.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Three groups involved. One control group and two nerve block groups with different drug concentration
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Concentration-Volume Relationship of Bupivacaine in Femoral Nerve Block Efficiency for Postoperative Analgesia in Primary Total Knee Arthroplasty: A Randomized Controlled Double Blind Clinical Trial
Actual Study Start Date : August 10, 2018
Actual Primary Completion Date : December 12, 2018
Actual Study Completion Date : February 15, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Sham Comparator: GCont
Only dressing will be applied to patients without actually nerve block performed
Other: Dressing
Only dressing will be applied to related area to protect blindness between groups

Active Comparator: G125 Block

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
Femoral nerve block will be applied post-operatively with guidance of USG and nerve stimulator
Other Name: Regional Anesthesia

Drug: Bupivacaine 0.125% Injectable Solution
Perineural Injection
Other Name: Marcain

Active Comparator: G25 Block

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
Femoral nerve block will be applied post-operatively with guidance of USG and nerve stimulator
Other Name: Regional Anesthesia

Drug: Bupivacaine 0.25% Injectable Solution
Perineural Injection
Other Name: Marcaine




Primary Outcome Measures :
  1. Post-operative pain assessed by Numeric Rating Scale (NRS) [ Time Frame: 30th minute postoperatively ]
    Pain scores will be recorded as reported by the patient according to NRS

  2. Post-operative pain assessed by Numeric Rating Scale (NRS) [ Time Frame: 1st hour postoperatively ]
    Pain scores will be recorded as reported by the patient according to NRS

  3. Post-operative pain assessed by Numeric Rating Scale (NRS) [ Time Frame: 2nd hour postoperatively ]
    Pain scores will be recorded as reported by the patient according to NRS

  4. Post-operative pain assessed by Numeric Rating Scale (NRS) [ Time Frame: 6th hour postoperatively ]
    Pain scores will be recorded as reported by the patient according to NRS

  5. Post-operative pain assessed by Numeric Rating Scale (NRS) [ Time Frame: 12th hour postoperatively ]
    Pain scores will be recorded as reported by the patient according to NRS

  6. Post-operative pain assessed by Numeric Rating Scale (NRS) [ Time Frame: 24th hour postoperatively ]
    Pain scores will be recorded as reported by the patient according to NRS

  7. Post-operative pain assessed by Numeric Rating Scale (NRS) [ Time Frame: 48th hour postoperatively ]
    Pain scores will be recorded as reported by the patient according to NRS


Secondary Outcome Measures :
  1. Ambulation Time [ Time Frame: 72 hours post-operatively ]
    First time a patients can walk around independently

  2. Opioid Consumption [ Time Frame: 48 hour post-operatively ]
    Opioids(Tramadol) will be administered to patients in case demanded.


Other Outcome Measures:
  1. Long Term Infection [ Time Frame: Six months post-operatively ]
    Surgery site or prosthesis infection in six months following surgery



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03623230


Locations
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Turkey
Izmir Bozyaka Training and Research Hospital
Karabaglar, İzmir, Turkey, 35170
Sponsors and Collaborators
Bozyaka Training and Research Hospital
Investigators
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Study Director: Zeki T TEKGUL, Associate Professor Izmir Bozyaka Training and Research Hospital
Publications:
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Responsible Party: Bozyaka Training and Research Hospital
ClinicalTrials.gov Identifier: NCT03623230    
Other Study ID Numbers: DizFemoralKonsant
First Posted: August 9, 2018    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Bozyaka Training and Research Hospital:
Femoral nerve block
peripheral nerve block
Concentration
volume
bupivacaine
post operative analgesia
total knee arthroplasty
Additional relevant MeSH terms:
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Pain, Postoperative
Neurologic Manifestations
Postoperative Complications
Pathologic Processes
Pain
Bupivacaine
Pharmaceutical Solutions
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents