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Does a Single Shot Femoral Nerve Block Alone Produce Appropriate Pain Relief?

Primary Purpose

Post-operative Pain

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Femoral Nerve Block
Combined nerve blocks
Patient-controlled analgesia
Sponsored by
Hillel Yaffe Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-operative Pain

Eligibility Criteria

30 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ASA I-III
  • Undergoing two TKA
  • Understanding PCA protocol

Exclusion Criteria:

  • Skin infection near injection site
  • Allergy to local analgesics
  • Peripheral neuropathy
  • Coagulopathy
  • Dementia
  • Proven opioid dependency

Sites / Locations

  • Hillel Yaffe Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Femoral Nerve Block

Combined Nerve Blocks

Patient-controlled analgesia

Arm Description

Outcomes

Primary Outcome Measures

Efficacy of single short femoral nerve block

Secondary Outcome Measures

Full Information

First Posted
February 20, 2011
Last Updated
January 20, 2015
Sponsor
Hillel Yaffe Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01303120
Brief Title
Does a Single Shot Femoral Nerve Block Alone Produce Appropriate Pain Relief?
Official Title
Does a Single Shot Femoral Nerve Block Alone Produce Appropriate Pain Relief After Total Knee Arthroplasty or Should an Addition of Sciatic, Obturator and Lateral Femoral Cutaneous Nerve Blocks be Recommended?
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hillel Yaffe Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of this study is to compare the efficacy of the analgesic effect of the preoperative femoral nerve block alone versus combined femoral, sciatic, obturator and lateral femoral cutaneous nerve blocks in patients after TKA in the immediate postoperative period.
Detailed Description
Bupivacaine will be used for all the nerve blocks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-operative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
107 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Femoral Nerve Block
Arm Type
Active Comparator
Arm Title
Combined Nerve Blocks
Arm Type
Active Comparator
Arm Title
Patient-controlled analgesia
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Femoral Nerve Block
Intervention Description
Preoperative Bupivacaine 0.5%, perineurally as single shot
Intervention Type
Drug
Intervention Name(s)
Combined nerve blocks
Intervention Description
Preoperative Bupivacaine 0.5%, perineurally as single shot
Intervention Type
Drug
Intervention Name(s)
Patient-controlled analgesia
Intervention Description
Patient controlled analgesia with morphine
Primary Outcome Measure Information:
Title
Efficacy of single short femoral nerve block
Time Frame
Three days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ASA I-III Undergoing two TKA Understanding PCA protocol Exclusion Criteria: Skin infection near injection site Allergy to local analgesics Peripheral neuropathy Coagulopathy Dementia Proven opioid dependency
Facility Information:
Facility Name
Hillel Yaffe Medical Center
City
Hadera
ZIP/Postal Code
38100
Country
Israel

12. IPD Sharing Statement

Citations:
PubMed Identifier
28178436
Citation
Stav A, Reytman L, Sevi R, Stav MY, Powell D, Dor Y, Dudkiewicz M, Bayadse F, Sternberg A, Soudry M. Femoral versus Multiple Nerve Blocks for Analgesia after Total Knee Arthroplasty. Rambam Maimonides Med J. 2017 Jan 30;8(1):e0006. doi: 10.5041/RMMJ.10281.
Results Reference
derived

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Does a Single Shot Femoral Nerve Block Alone Produce Appropriate Pain Relief?

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