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Concentration Effect of Local Anesthetics on Femoral Nerve Block Efficiency

Primary Purpose

Anesthesia, Conduction, Arthroplasty, Replacement, Knee, Pain, Postoperative

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Ultrasound Guided Femoral Nerve Block
Dressing
Bupivacaine 0.25% Injectable Solution
Bupivacaine 0.125% Injectable Solution
Sponsored by
Bozyaka Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anesthesia, Conduction focused on measuring Femoral nerve block, peripheral nerve block, Concentration, volume, bupivacaine, post operative analgesia, total knee arthroplasty

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Izmir Bozyaka Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Sham Comparator

Active Comparator

Active Comparator

Arm Label

GCont

G125 Block

G25 Block

Arm Description

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

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.

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.

Outcomes

Primary Outcome Measures

Post-operative pain assessed by Numeric Rating Scale (NRS)
Pain scores will be recorded as reported by the patient according to NRS
Post-operative pain assessed by Numeric Rating Scale (NRS)
Pain scores will be recorded as reported by the patient according to NRS
Post-operative pain assessed by Numeric Rating Scale (NRS)
Pain scores will be recorded as reported by the patient according to NRS
Post-operative pain assessed by Numeric Rating Scale (NRS)
Pain scores will be recorded as reported by the patient according to NRS
Post-operative pain assessed by Numeric Rating Scale (NRS)
Pain scores will be recorded as reported by the patient according to NRS
Post-operative pain assessed by Numeric Rating Scale (NRS)
Pain scores will be recorded as reported by the patient according to NRS
Post-operative pain assessed by Numeric Rating Scale (NRS)
Pain scores will be recorded as reported by the patient according to NRS

Secondary Outcome Measures

Ambulation Time
First time a patients can walk around independently
Opioid Consumption
Opioids(Tramadol) will be administered to patients in case demanded.

Full Information

First Posted
June 30, 2018
Last Updated
July 8, 2019
Sponsor
Bozyaka Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03623230
Brief Title
Concentration Effect of Local Anesthetics on Femoral Nerve Block Efficiency
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
August 10, 2018 (Actual)
Primary Completion Date
December 12, 2018 (Actual)
Study Completion Date
February 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bozyaka Training and Research Hospital

4. Oversight

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

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Three groups involved. One control group and two nerve block groups with different drug concentration
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GCont
Arm Type
Sham Comparator
Arm Description
Only dressing will be applied to patients without actually nerve block performed
Arm Title
G125 Block
Arm Type
Active Comparator
Arm Description
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.
Arm Title
G25 Block
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Ultrasound Guided Femoral Nerve Block
Other Intervention Name(s)
Regional Anesthesia
Intervention Description
Femoral nerve block will be applied post-operatively with guidance of USG and nerve stimulator
Intervention Type
Other
Intervention Name(s)
Dressing
Intervention Description
Only dressing will be applied to related area to protect blindness between groups
Intervention Type
Drug
Intervention Name(s)
Bupivacaine 0.25% Injectable Solution
Other Intervention Name(s)
Marcaine
Intervention Description
Perineural Injection
Intervention Type
Drug
Intervention Name(s)
Bupivacaine 0.125% Injectable Solution
Other Intervention Name(s)
Marcain
Intervention Description
Perineural Injection
Primary Outcome Measure Information:
Title
Post-operative pain assessed by Numeric Rating Scale (NRS)
Description
Pain scores will be recorded as reported by the patient according to NRS
Time Frame
30th minute postoperatively
Title
Post-operative pain assessed by Numeric Rating Scale (NRS)
Description
Pain scores will be recorded as reported by the patient according to NRS
Time Frame
1st hour postoperatively
Title
Post-operative pain assessed by Numeric Rating Scale (NRS)
Description
Pain scores will be recorded as reported by the patient according to NRS
Time Frame
2nd hour postoperatively
Title
Post-operative pain assessed by Numeric Rating Scale (NRS)
Description
Pain scores will be recorded as reported by the patient according to NRS
Time Frame
6th hour postoperatively
Title
Post-operative pain assessed by Numeric Rating Scale (NRS)
Description
Pain scores will be recorded as reported by the patient according to NRS
Time Frame
12th hour postoperatively
Title
Post-operative pain assessed by Numeric Rating Scale (NRS)
Description
Pain scores will be recorded as reported by the patient according to NRS
Time Frame
24th hour postoperatively
Title
Post-operative pain assessed by Numeric Rating Scale (NRS)
Description
Pain scores will be recorded as reported by the patient according to NRS
Time Frame
48th hour postoperatively
Secondary Outcome Measure Information:
Title
Ambulation Time
Description
First time a patients can walk around independently
Time Frame
72 hours post-operatively
Title
Opioid Consumption
Description
Opioids(Tramadol) will be administered to patients in case demanded.
Time Frame
48 hour post-operatively
Other Pre-specified Outcome Measures:
Title
Long Term Infection
Description
Surgery site or prosthesis infection in six months following surgery
Time Frame
Six months post-operatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zeki T TEKGUL, Associate Professor
Organizational Affiliation
Izmir Bozyaka Training and Research Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Izmir Bozyaka Training and Research Hospital
City
Karabaglar
State/Province
İzmir
ZIP/Postal Code
35170
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28273133
Citation
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.
Results Reference
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PubMed Identifier
28971169
Citation
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.
Results Reference
background
PubMed Identifier
29026354
Citation
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.
Results Reference
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Concentration Effect of Local Anesthetics on Femoral Nerve Block Efficiency

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