Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 29 of 29 for:    "Collagen Disease" | "Dexamethasone acetate"

Lumbar Plexus and Suprainguinal Fascia Iliaca Blocks For Total Hip Replacement

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03744065
Recruitment Status : Recruiting
First Posted : November 16, 2018
Last Update Posted : November 20, 2018
Sponsor:
Information provided by (Responsible Party):
Daniela Bravo Advis, University of Chile

Brief Summary:

The nerves from lumbar plexus (LP) are the current target to achieve analgesia after a total hip arthroplasty (THA). Lumbar plexus block (LPB) is an alternative that provides optimal postoperative analgesia. However, many adverse effects and complications have been reported due to its proximity to vital structures. Because of these shortcomings, an alternative to block the LP nerves is required.

In a recent trial suprainguinal Fascia Iliaca Block (SFIB) was reported to provide reliable analgesia in THA. SFIB may carry a lower risk profile, however, no study has compared the efficacy of LPB and SFIB in this setting.

Thus, this randomized trial is set out to compare US guided LPB and SFIB for analgesia after THA. The hypothesis is that both blocks would result in similar postoperative opioid (morphine) consumption at 24 hours and, therefore, designed the study as an equivalence trial.


Condition or disease Intervention/treatment Phase
Hip Osteoarthritis Pain, Acute Pain, Postoperative Opioid Use Procedure: lumbar plexus block Procedure: suprainguinal fascia iliaca block Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Comparison Between Ultrasound Guided Lumbar Plexus and Suprainguinal Fascia Iliaca Blocks For Total Hip Replacement Analgesia
Actual Study Start Date : November 19, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hip Replacement

Arm Intervention/treatment
Active Comparator: Lumbar plexus block
Patients randomized to receive an ultrasound-guided lumbar plexus block
Procedure: lumbar plexus block
Injection with ultrasound guidance of 40 mL of levobupivacaine 0.25% with 5 micrograms of epinephrine per mL and dexamethasone 4 milligrams, in the posteromedial quadrant of psoas muscle

Experimental: Suprainguinal fascia iliaca block
Patients randomized to receive an ultrasound-guided suprainguinal fascia iliaca block
Procedure: suprainguinal fascia iliaca block
Injection with ultrasound guidance of 40 mL of levobupivacaine 0.25% with 5 micrograms of epinephrine per mL and dexamethasone 4 milligrams, underneath the fascia iliaca at the suprainguinal level




Primary Outcome Measures :
  1. Morphine consumption over 24 hours [ Time Frame: 24 hours post block ]
    Total morphine consumption over 24 hours post block


Secondary Outcome Measures :
  1. Performance time [ Time Frame: 2 hours after surgery ]
    Interval between the start of skin disinfection and the end of local anesthetic injection

  2. Number of needle passes [ Time Frame: 2 hours after surgery ]
    The initial needle insertion counted as the first pass. Any subsequent needle advancement that is preceded by a retraction of at least 10 mm counts as an additional pass

  3. Postoperative static pain at 3 hours after block [ Time Frame: 3 hours after the block ]
    Pain evaluated in Numeric Rating Score from 0 to 10 points

  4. Postoperative static pain at 6 hours after block [ Time Frame: 6 hours after the block ]
    Pain evaluated in Numeric Rating Score from 0 to 10 points

  5. Postoperative static pain at 12 hours after block [ Time Frame: 12 hours after the block ]
    Pain evaluated in Numeric Rating Score from 0 to 10 points

  6. Postoperative static pain at 24 hours after block [ Time Frame: 24 hours after the block ]
    Pain evaluated in Numeric Rating Score from 0 to 10 points

  7. Postoperative dynamic pain at 3 hours after block [ Time Frame: 3 hours after the block ]
    Pain evaluated in Numeric Rating Score from 0 to 10 points

  8. Postoperative dynamic pain at 6 hours after block [ Time Frame: 6 hours after the block ]
    Pain evaluated in Numeric Rating Score from 0 to 10 points

  9. Postoperative dynamic pain at 12 hours after block [ Time Frame: 12 hours after the block ]
    Pain evaluated in Numeric Rating Score from 0 to 10 points

  10. Postoperative dynamic pain at 24 hours after block [ Time Frame: 24 hours after the block ]
    Pain evaluated in Numeric Rating Score from 0 to 10 points

  11. Postoperative static pain at 48 hours after block [ Time Frame: 48 hours after the block ]
    Pain evaluated in Numeric Rating Score from 0 to 10 points

  12. Postoperative dynamic pain at 48 hours after block [ Time Frame: 48 hours after the block ]
    Pain evaluated in Numeric Rating Score from 0 to 10 points

  13. Time until first morphine demand [ Time Frame: 48 hours after the block ]
    Time until first patient-controlled analgesia morphine demand

  14. Block assessment at 3 hours [ Time Frame: 3 hours after the block ]

    Sensorimotor block assessed using a 10-point composite score evaluating sensory block of the lateral femoral cutaneous, femoral and obturator nerves, and motor block of femoral and obturator nerves.

    Sensation will be assessed with ice on then lateral, anterior and medial thigh using a 0 to 2 point scale. 0= no block, patients can feel cold; 1= analgesic block, patient can feel touch but not cold; 2= anesthetic block, patient cannot feel cold or touch.

    Motor function will be assessed for each nerve with a 0 to 2 points scale where 0= no motor block; 1= paresis; 2= paralysis.


  15. Block assessment at 6 hours [ Time Frame: 6 hours after the block ]

    Sensorimotor block assessed using a 10-point composite score evaluating sensory block of the lateral femoral cutaneous, femoral and obturator nerves, and motor block of femoral and obturator nerves.

    Sensation will be assessed with ice on then lateral, anterior and medial thigh using a 0 to 2 point scale. 0= no block, patients can feel cold; 1= analgesic block, patient can feel touch but not cold; 2= anesthetic block, patient cannot feel cold or touch.

    Motor function will be assessed for each nerve with a 0 to 2 points scale where 0= no motor block; 1= paresis; 2= paralysis.


  16. Block assessment at 24 hours [ Time Frame: 24 hours after the block ]

    Sensorimotor block assessed using a 10-point composite score evaluating sensory block of the lateral femoral cutaneous, femoral and obturator nerves, and motor block of femoral and obturator nerves.

    Sensation will be assessed with ice on then lateral, anterior and medial thigh using a 0 to 2 point scale. 0= no block, patients can feel cold; 1= analgesic block, patient can feel touch but not cold; 2= anesthetic block, patient cannot feel cold or touch.

    Motor function will be assessed for each nerve with a 0 to 2 points scale where 0= no motor block; 1= paresis; 2= paralysis.


  17. Incidence of block related adverse events [ Time Frame: 3 hours after block ]
    Incidence of adverse events related to nerve block (vascular puncture, local anesthetic systemic toxicity, epidural spread)

  18. Incidence of opioid related adverse events [ Time Frame: 48 hours after block ]
    Incidence of adverse events related to opioid use (nausea/vomiting, pruritus, somnolence, respiratory depression)

  19. Incidence of Inability to perform physiotherapy [ Time Frame: 24 hours after the block ]
    Inability to perform physiotherapy due to pain (score more than 4 in Numeric Rating Score from 0 to 10 points) or motor blockade.

  20. Surgical duration [ Time Frame: 4 hours ]
    Time between skin incision and closure

  21. Readiness to discharge [ Time Frame: 4 days after surgery ]
    Days to be ready for discharge following physiotherapist criteria

  22. Length of hospital stay [ Time Frame: 7 days after surgery ]
    Length of hospital stay after surgery



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age between 18 and 80 years
  • American Society of Anesthesiologists classification 1-3
  • Body mass index between 20 and 35 (kg/m2)

Exclusion Criteria:

  • Adults who are unable to give their own consent
  • Pre-existing neuropathy (assessed by history and physical examination)
  • Coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. platelets ≤ 100, International Normalized Ratio ≥ 1.4 or prothrombin time ≥ 50)
  • Renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. creatinine ≥ 100)
  • Hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. transaminases ≥ 100)
  • Allergy to local anesthetics (LAs) or morphine
  • Pregnancy
  • Prior surgery in the corresponding side of the lumbar o suprainguinal area
  • Chronic pain syndromes requiring opioid intake at home

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): NCT03744065


Contacts
Layout table for location contacts
Contact: Daniela Bravo, MD +56229788000 dbravoadvis@uchile.cl

Locations
Layout table for location information
Chile
Hospital Clínico Universidad de Chile Recruiting
Santiago, Metropolitana, Chile, 8380456
Contact: Daniela Bravo, MD    56984276252    dbravoadvis@uchile.cl   
Contact: Julian Aliste, MD    56998189445    julian.aliste@uchile.cl   
Sponsors and Collaborators
University of Chile
Investigators
Layout table for investigator information
Principal Investigator: Daniela Bravo, MD University of Chile

Publications:

Layout table for additonal information
Responsible Party: Daniela Bravo Advis, Assistant Professor, University of Chile
ClinicalTrials.gov Identifier: NCT03744065     History of Changes
Other Study ID Numbers: OAIC1001/18
First Posted: November 16, 2018    Key Record Dates
Last Update Posted: November 20, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Daniela Bravo Advis, University of Chile:
nerve block
fascia iliaca
hip replacement
lumbar plexus

Additional relevant MeSH terms:
Layout table for MeSH terms
Rheumatic Diseases
Osteoarthritis
Osteoarthritis, Hip
Pain, Postoperative
Acute Pain
Arthritis
Joint Diseases
Musculoskeletal Diseases
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Levobupivacaine
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents