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Femoral/Sciatic Block for Knee Surgery

Primary Purpose

Knee Injuries

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
femoral nerve blockade
morphine
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Injuries focused on measuring Analgesia, Nerve Block, Pain, Postoperative

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients aged over 18 years old, American Society of Anesthesiologists (ASA) physical status from I to III who underwent total knee arthroplasty

Exclusion Criteria:

  • Patients aged below 18 years old, ASA IV or V physical status, infection near the puncture site, coagulation disorders, preexisting neurological disorders, allergy report to local anesthetics, pregnancy and lactation, contraindications to spinal block and refusal to sign an informed consent form

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    femoral blockade

    Morphine

    Arm Description

    femoral nerve blockade followed by a catheter placement for continuous infusion and a "single shot" block of the sciatic nerve

    intrathecal morphine

    Outcomes

    Primary Outcome Measures

    Analgesic Efficacy
    Pain with verbal numeric rating scale (VNRS). VNRS has 11 points, from zero to 10 (zero= no pain, 1-3 = mild pain, 4-5 = moderate pain, 7-9 = severe pain, 10 = unbearable pain).

    Secondary Outcome Measures

    Postoperative Bleeding
    Postoperative bleeding volume (ml)

    Full Information

    First Posted
    August 24, 2016
    Last Updated
    December 23, 2016
    Sponsor
    University of Sao Paulo General Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02882152
    Brief Title
    Femoral/Sciatic Block for Knee Surgery
    Official Title
    Continuous Femoral Nerve Blockade and Single Shot Sciatic Nerve Block Compared to Intrathecal Morphine for Total Knee Arthroplasty
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2011 (undefined)
    Primary Completion Date
    September 2014 (Actual)
    Study Completion Date
    September 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Sao Paulo General Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Knee arthroplasty has a high potential for postoperative pain. This study compares analgesia and postoperative bleeding from intrathecal morphine with the continuous femoral and a single-shot sciatic nerve blockades.
    Detailed Description
    This study aims to compare intrathecal morphine as a technique for analgesia with the femoral nerve blockade associated with a single-shot sciatic nerve blockade. Analgesic efficacy, the incidence of adverse effects, and postoperative bleeding were evaluated

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Knee Injuries
    Keywords
    Analgesia, Nerve Block, Pain, Postoperative

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    femoral blockade
    Arm Type
    Experimental
    Arm Description
    femoral nerve blockade followed by a catheter placement for continuous infusion and a "single shot" block of the sciatic nerve
    Arm Title
    Morphine
    Arm Type
    Active Comparator
    Arm Description
    intrathecal morphine
    Intervention Type
    Procedure
    Intervention Name(s)
    femoral nerve blockade
    Intervention Description
    femoral nerve blockade followed by a catheter placement for continuous infusion and a "single shot" block of the sciatic nerve at the end of the surgery
    Intervention Type
    Procedure
    Intervention Name(s)
    morphine
    Intervention Description
    Intrathecal morphine injection
    Primary Outcome Measure Information:
    Title
    Analgesic Efficacy
    Description
    Pain with verbal numeric rating scale (VNRS). VNRS has 11 points, from zero to 10 (zero= no pain, 1-3 = mild pain, 4-5 = moderate pain, 7-9 = severe pain, 10 = unbearable pain).
    Time Frame
    baseline (zero hour: discharge of post-anesthesia care unit-PACU), 24hs, 48hs, 72 hours
    Secondary Outcome Measure Information:
    Title
    Postoperative Bleeding
    Description
    Postoperative bleeding volume (ml)
    Time Frame
    baseline (discharge of post-anesthesia care unit-PACU), 24hs, 48hs, 72 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients aged over 18 years old, American Society of Anesthesiologists (ASA) physical status from I to III who underwent total knee arthroplasty Exclusion Criteria: Patients aged below 18 years old, ASA IV or V physical status, infection near the puncture site, coagulation disorders, preexisting neurological disorders, allergy report to local anesthetics, pregnancy and lactation, contraindications to spinal block and refusal to sign an informed consent form
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Alfredo J Mansur, MD. PhD
    Organizational Affiliation
    Comissão de Ética para Análise de Projetos de Pesquisa-CAPPesq - HCFMUSP
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    25111605
    Citation
    Bauer MC, Pogatzki-Zahn EM, Zahn PK. Regional analgesia techniques for total knee replacement. Curr Opin Anaesthesiol. 2014 Oct;27(5):501-6. doi: 10.1097/ACO.0000000000000115.
    Results Reference
    background
    PubMed Identifier
    26731032
    Citation
    Guay J, Kopp S. Epidural pain relief versus systemic opioid-based pain relief for abdominal aortic surgery. Cochrane Database Syst Rev. 2016 Jan 5;2016(1):CD005059. doi: 10.1002/14651858.CD005059.pub4.
    Results Reference
    background
    PubMed Identifier
    22798178
    Citation
    Bujedo BM, Santos SG, Azpiazu AU. A review of epidural and intrathecal opioids used in the management of postoperative pain. J Opioid Manag. 2012 May-Jun;8(3):177-92. doi: 10.5055/jom.2012.0114.
    Results Reference
    background
    PubMed Identifier
    19462494
    Citation
    Gehling M, Tryba M. Risks and side-effects of intrathecal morphine combined with spinal anaesthesia: a meta-analysis. Anaesthesia. 2009 Jun;64(6):643-51. doi: 10.1111/j.1365-2044.2008.05817.x.
    Results Reference
    background
    PubMed Identifier
    27370542
    Citation
    Li XM, Huang CM, Zhong CF. Intrathecal morphine verse femoral nerve block for pain control in total knee arthroplasty: A meta-analysis from randomized control trials. Int J Surg. 2016 Aug;32:89-98. doi: 10.1016/j.ijsu.2016.06.043. Epub 2016 Jul 6.
    Results Reference
    background
    PubMed Identifier
    19388886
    Citation
    Kadic L, Boonstra MC, DE Waal Malefijt MC, Lako SJ, VAN Egmond J, Driessen JJ. Continuous femoral nerve block after total knee arthroplasty? Acta Anaesthesiol Scand. 2009 Aug;53(7):914-20. doi: 10.1111/j.1399-6576.2009.01965.x. Epub 2009 Apr 15.
    Results Reference
    background
    PubMed Identifier
    27469381
    Citation
    Grape S, Kirkham KR, Baeriswyl M, Albrecht E. The analgesic efficacy of sciatic nerve block in addition to femoral nerve block in patients undergoing total knee arthroplasty: a systematic review and meta-analysis. Anaesthesia. 2016 Oct;71(10):1198-209. doi: 10.1111/anae.13568. Epub 2016 Jul 29.
    Results Reference
    background
    PubMed Identifier
    1170786
    Citation
    Raj PP, Parks RI, Watson TD, Jenkins MT. A new single-position supine approach to sciatic-femoral nerve block. Anesth Analg. 1975 Jul-Aug;54(4):489-93. doi: 10.1213/00000539-197507000-00020.
    Results Reference
    background
    PubMed Identifier
    28499420
    Citation
    Alvarez NER, Ledesma RJG, Hamaji A, Hamaji MWM, Vieira JE. Continuous femoral nerve blockade and single-shot sciatic nerve block promotes better analgesia and lower bleeding for total knee arthroplasty compared to intrathecal morphine: a randomized trial. BMC Anesthesiol. 2017 May 12;17(1):64. doi: 10.1186/s12871-017-0355-x.
    Results Reference
    derived

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    Femoral/Sciatic Block for Knee Surgery

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