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Continuous Nerve Block Block vs Combination of Single Block Plus Intravenous Lidocaine for Postoperative Pain.

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: NCT04208516
Recruitment Status : Not yet recruiting
First Posted : December 23, 2019
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
Jacques E. Chelly, University of Pittsburgh

Brief Summary:
A multimodal analgesic regimen including regional anesthesia is used at UPMC Shadyside for primary thoracic and major abdominal surgeries. The current standard-of-care regional anesthesia techniques include Erector Spinae Plane (ESP) block for video assisted thorascopic surgery (VATS) and Quadratus Lumborum (QL) block for major abdominal surgery. These blocks are routinely administered as a continuous catheter technique in order to extend the duration of postoperative analgesia. Although rare, continuous nerve block techniques carry risks and limitations, including catheter dislodgement, migration, kinking and leaking at the site, bleeding, and infection. They are also much more expensive to perform and maintain than single-injection nerve blocks at this institution. Perioperative intravenous (IV) lidocaine is one of the safest local anesthetics, and its use has been shown to provide analgesia and reduce opioid requirements. Furthermore, it has been hypothesized that part of the analgesic efficacy of continuous peripheral nerve blocks may be due to the systemic effects of the local anesthetic infused at the site. Therefore, it is possible that the combination of a single block followed by an infusion of IV lidocaine may provide the same benefits as a continuous nerve block at a lower cost. The purpose of this study is to show that a single block technique plus IV lidocaine is non-inferior to a continuous block technique. For the purpose of this study we chose two surgical models--VATS and major abdominal surgery--and ESP and QL blocks, respectively. The study will be conducted as a prospective, randomized (1:1), open-label, active-comparator, noninferiority trial. The study will prospectively investigate the efficacy of continuous block versus single block plus IV lidocaine infusion for postoperative pain management in patients undergoing primary unilateral VATS or primary major abdominal surgery.

Condition or disease Intervention/treatment Phase
Postoperative Pain Procedure: Continuous Erector Spinae Plane Nerve Block Procedure: Continuous Quadratus Lumborum Nerve Block Procedure: Single Erector Spinae Plane Nerve Block Procedure: Single Quadratus Lumborum Nerve Block Drug: Lidocaine IV Drug: Ropivacaine 0.5% Injectable Solution Drug: Dexamethasone Drug: Dexmedetomidine Drug: Lidocaine Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two groups of patients will be studied simultaneously. One group will receive continuous peripheral nerve blocks and the other group will receive single blocks plus postoperative intravenous lidocaine infusion.
Masking: Single (Outcomes Assessor)
Masking Description: For study participants, the investigator placing the block will record in the narrative that "this patient is a study participant and received Paravertebral block with ESP approach" or "this patient is a study participant and received TAP block with QL approach". By documenting blocks in this way, the research team member collecting the data will be blinded to whether the patient received continuous block with 0.5% ropivacaine, or single block with 0.5% ropivacaine, dexamethasone, and dexmedetomidine.
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Active-Comparator, Open-Label, Non-Inferiority Study of the Efficacy of Continuous Nerve Block vs Single Block Plus Intravenous Lidocaine for Postoperative Pain.
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Continuous nerve blocks
A total of 30 subjects equally distributed to either continuous Erector Spinae Plane block for unilateral thoracic surgery , or continuous Quadratus Lumborum block for major abdominal surgery. Patients in this group will receive 20ml 0.5% ropivacaine per block performed after positioning of the needle followed by continuous perineural infusion of 0.25% lidocaine (10ml/hr) beginning in the post-anesthesia care unit (PACU) and continued for 72 hours or until 12 hours prior to patient discharge, whichever comes first, which is standard of care at this institution.
Procedure: Continuous Erector Spinae Plane Nerve Block
To be administered to subjects in the active comparator group receiving primary unilateral thoracic surgery.

Procedure: Continuous Quadratus Lumborum Nerve Block
To be administered to subjects in the active comparator group receiving primary major abdominal surgery.

Drug: Ropivacaine 0.5% Injectable Solution
To be used in both treatment arms as nerve block initial bolus injection.

Drug: Lidocaine
To be used perineurally as a 0.25% solution in the active comparator group at a rate of 10 ml/hr per perineural catheter.

Experimental: Single nerve blocks plus IV lidocaine infusion
A total of 30 subjects equally distributed to either Erector Spinae Plane block for unilateral thoracic surgery, or Quadratus Lumborum block for major abdominal surgery, will be included . Patients in this group will receive 20ml 0.5% ropivacaine, 4mg dexamethasone, and 20mcg dexmedetomidine (30mcg if only one block is performed) per block after proper positioning of the Tuohy needle. Upon patient arrival in the recovery room a continuous infusion of IV lidocaine 50 mg /hr will be started and continued for 72 hours or until 12 hours prior to patient discharge, whichever comes first, which is standard of care at this institution.
Procedure: Single Erector Spinae Plane Nerve Block
To be administered to subjects in the experimental group receiving primary unilateral thoracic surgery.

Procedure: Single Quadratus Lumborum Nerve Block
To be administered to subjects in the experimental group receiving primary major abdominal surgery.

Drug: Lidocaine IV
To be given postoperatively as a continuous infusion at a dose of 50 mg/hr in the experimental group.

Drug: Ropivacaine 0.5% Injectable Solution
To be used in both treatment arms as nerve block initial bolus injection.

Drug: Dexamethasone
To be used in the experimental arm as a nerve block adjuvant to promote prolonged single block duration, as is standard of care in this institution.

Drug: Dexmedetomidine
To be used in the experimental arm as a nerve block adjuvant to promote prolonged single block duration, as is standard of care in this institution.




Primary Outcome Measures :
  1. Opioid consumption after surgery [ Time Frame: 24 hours after surgery ]
    Opioids will be converted to oral morphine equivalents


Secondary Outcome Measures :
  1. Opioid consumption after surgery [ Time Frame: 48 hours after surgery ]
    Opioids will be converted to oral morphine equivalents

  2. Opioid consumption after surgery [ Time Frame: 72 hours after surgery ]
    Opioids will be converted to oral morphine equivalents

  3. Pain after surgery [ Time Frame: 6 hours after surgery ]
    By numeric pain rating scale, 0 = no pain and 10 = worst possible pain

  4. Pain after surgery [ Time Frame: 12 hours after surgery ]
    By numeric pain rating scale, 0 = no pain and 10 = worst possible pain

  5. Pain after surgery [ Time Frame: 24 hours after surgery ]
    By numeric pain rating scale, 0 = no pain and 10 = worst possible pain

  6. Pain after surgery [ Time Frame: 48 hours after surgery ]
    By numeric pain rating scale, 0 = no pain and 10 = worst possible pain

  7. Pain after surgery [ Time Frame: 72 hours after surgery ]
    By numeric pain rating scale, 0 = no pain and 10 = worst possible pain

  8. Local anesthetic consumption after surgery [ Time Frame: 12 hours after surgery ]
    Reported in mg of lidocaine

  9. Local anesthetic consumption after surgery [ Time Frame: 24 hours after surgery ]
    Reported in mg of lidocaine

  10. Local anesthetic consumption after surgery [ Time Frame: 48 hours after surgery ]
    Reported in mg of lidocaine

  11. Local anesthetic consumption after surgery [ Time Frame: 72 hours after surgery ]
    Reported in mg of lidocaine

  12. Serum lidocaine level [ Time Frame: 24 hours after surgery ]
  13. Serum lidocaine level [ Time Frame: 48 hours after surgery ]
  14. Serum lidocaine level [ Time Frame: 72 hours after surgery ]
  15. Total hospital length of stay [ Time Frame: From admission to discharge, on average 1-4 days ]
  16. Incidence of adverse events [ Time Frame: From time of surgery to discharge, on average 1-4 days ]
    Nausea and vomiting requiring treatment, hypotension, and bradycardia or tachycardia



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.


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18-90 years old
  • Primary unilateral VATS or major abdominal surgery
  • BMI 20-36, weight ≥ 50kg
  • Male and Female
  • All races

Exclusion Criteria:

  • Patient refusal
  • Inpatient status at the time of surgery
  • ASA class 4 or greater
  • Pregnancy
  • Non-English speaking or inability to participate in the study
  • Patients with coagulopathy or on therapeutic anticoagulation
  • Chronic steroid use
  • Opioid use disorder
  • Contraindication to performing any of the proposed blocks - active infection at the block site, systemic infection, allergy to local anesthetic medications
  • Patients undergoing second surgery or urgent/emergent surgery
  • Patients weighing < 50kg
  • History of chronic pain and/or opioid tolerant
  • Anticipated requirement for patient-controlled analgesia (PCA)
  • Allergy or intolerance to any medication specified in the study protocol or postoperative pain management regimen
  • Liver disease

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): NCT04208516


Contacts
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Contact: Jacques E Chelly, MD, PhD, MBA 412-623-6904 chelje@anes.upmc.edu

Locations
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United States, Pennsylvania
UPMC Shadyside Hospital
Pittsburgh, Pennsylvania, United States, 15232
Contact: Amy Monroe    412-623-6382    monroeal@upmc.edu   
Sponsors and Collaborators
Jacques E. Chelly
Investigators
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Principal Investigator: Jacques E Chelly, MD, PhD, MBA University of Pittsburgh Medical Center
Publications:

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Responsible Party: Jacques E. Chelly, Professor of Anesthesiology and Perioperative Medicine, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT04208516    
Other Study ID Numbers: STUDY19100057
First Posted: December 23, 2019    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Jacques E. Chelly, University of Pittsburgh:
intravenous lidocaine
erector spinae plane block
quadratus lumborum block
thoracic surgery
abdominal surgery
continuous peripheral nerve block
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Dexamethasone
Lidocaine
Dexmedetomidine
Ropivacaine
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action