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Femoral/Sciatic Block for Knee Surgery

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: NCT02882152
Recruitment Status : Completed
First Posted : August 29, 2016
Results First Posted : December 26, 2016
Last Update Posted : December 26, 2016
Sponsor:
Information provided by (Responsible Party):
University of Sao Paulo General Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Knee Injuries Procedure: femoral nerve blockade Procedure: morphine Not Applicable

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
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Continuous Femoral Nerve Blockade and Single Shot Sciatic Nerve Block Compared to Intrathecal Morphine for Total Knee Arthroplasty
Study Start Date : August 2011
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

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Arms and Interventions
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Arm Intervention/treatment
Experimental: femoral blockade
femoral nerve blockade followed by a catheter placement for continuous infusion and a "single shot" block of the sciatic nerve
 Procedure: femoral nerve blockade
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
Active Comparator: Morphine
intrathecal morphine
 Procedure: morphine
Intrathecal morphine injection


Outcome Measures
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Primary Outcome Measures :
  1. Analgesic Efficacy [ Time Frame: baseline (zero hour: discharge of post-anesthesia care unit-PACU), 24hs, 48hs, 72 hours ]
    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 :
  1. Postoperative Bleeding [ Time Frame: baseline (discharge of post-anesthesia care unit-PACU), 24hs, 48hs, 72 hours ]
    Postoperative bleeding volume (ml)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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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): NCT02882152


Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
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Study Director: Alfredo J Mansur, MD. PhD Comissão de Ética para Análise de Projetos de Pesquisa-CAPPesq - HCFMUSP
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT02882152    
Other Study ID Numbers: 0257/09
First Posted: August 29, 2016    Key Record Dates
Results First Posted: December 26, 2016
Last Update Posted: December 26, 2016
Last Verified: September 2014
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Sao Paulo General Hospital:
Analgesia
Nerve Block
Pain, Postoperative
Additional relevant MeSH terms:
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Knee Injuries
Leg Injuries
Wounds and Injuries
Morphine
Analgesics, Opioid
Narcotics
 Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents