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QLB After Nephrectomy

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: NCT03529201
Recruitment Status : Unknown
Verified July 2018 by Michał Borys, Medical University of Lublin.
Recruitment status was:  Recruiting
First Posted : May 18, 2018
Last Update Posted : July 18, 2018
Sponsor:
Collaborators:
Department of Anesthesiology and Intensive Care, F. Chopin Hospital in Rzeszów
Department of Anesthesiology and Intensive Care, J. Śniadecki Hospital in Białystok
Information provided by (Responsible Party):
Michał Borys, Medical University of Lublin

Brief Summary:
Oxycodone consumption and postoperative pain intensity in patients undergoing nephrectomy procedures. Of all study participants, 50% will obtain quadratus lumborum block (QLB).

Condition or disease Intervention/treatment Phase
Pain, Postoperative Chronic Postoperative Pain Procedure: QLB Device: PCA Procedure: GA Drug: Oxycodone Drug: Sevoflurane Drug: Fentanyl Drug: Rocuronium Not Applicable

Detailed Description:

Patients undergoing nephrectomy procedures will be allocated to one of the study arms. At the end of an operation, still under general anesthesia, 50% patients will obtain QLB with ropivacaine.

Ultrasound-guided QLB will be performed on the side of surgery with 0.375% ropivacaine solution (0.2 mL per kg).

Every patient will get patient-controlled analgesia pump with oxycodone in the postoperative period.

Postoperative pain will be measured with VAS (visual-analogue scale) 2, 4, 8, 12 and 24 hours after the end of the operation. 24 -hours period.

At the 1, 3, 6 months patients will be interviewed by phone to assess neuropathic pain. Neuropathic Pain Symptom Inventory (NPSI) will be used.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients will be randomly allocated to one of the study arms: QLB or control group.
Masking: Single (Participant)
Masking Description: A regional block will be performed under general anesthesia. Patients will not be aware of this procedure.
Primary Purpose: Treatment
Official Title: Effectiveness of Quadratus Lumborum Block After Nephrectomy
Actual Study Start Date : May 7, 2018
Estimated Primary Completion Date : September 28, 2018
Estimated Study Completion Date : February 25, 2019

Arm Intervention/treatment
Experimental: QLB
At the end of surgery, QLB with ropivacaine will be done on the side of the operation.
Procedure: QLB
On the side of the surgery, QLB with 0.375% ropivacaine (0.2 mL/kg)

Device: PCA
Patient-controlled analgesia

Procedure: GA
General anesthesia

Drug: Oxycodone
administered by PCA

Drug: Sevoflurane
Inhalational anesthetic during GA

Drug: Fentanyl
painkiller during GA

Drug: Rocuronium
muscle relaxant during GA

Experimental: Control
Standard care. No regional blocks.
Device: PCA
Patient-controlled analgesia

Procedure: GA
General anesthesia

Drug: Oxycodone
administered by PCA

Drug: Sevoflurane
Inhalational anesthetic during GA

Drug: Fentanyl
painkiller during GA

Drug: Rocuronium
muscle relaxant during GA




Primary Outcome Measures :
  1. Total consumption of oxycodone [ Time Frame: 24 hours after the end of surgery. ]
    Overall use of oxycodone administered by PCA pump will be assessed.


Secondary Outcome Measures :
  1. Pain intensity [ Time Frame: 24 hours after the end of surgery ]
    Pain intensity measured on VAS scale at the 2, 4, 8, 12, 24 hours. VAS in milimmeters. Minimum value 0, maximum 100. Less better - less severe pain. 0 no pain at all.

  2. Chronic pain [ Time Frame: 6 months after the surgery ]
    Chronic pain occurrence assessed with Neuropathic Pain Symptom Inventory (NPSI) 10 descriptive variables, each one from 0 to 10. 0 means no pain. 10 very high chance of occurrence of neuropathic pain.



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

Inclusion Criteria:

  • obtained consent
  • nephrectomy procedure

Exclusion Criteria:

  • coagulopathy allergy to local anesthetics depression, antidepressant drugs treatment epilepsy usage of painkiller before surgery addiction to alcohol or recreational drugs

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): NCT03529201


Contacts
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Contact: Michał Borys, M.D., Ph.D. +48506350569 michalborys1@gmail.com
Contact: Mirosław Czuczwar, M.D., Ph.D. +48509390985 czuczwarm@gmail.com

Locations
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Poland
Department of Anesthesiology and Intensive Care, J. Śniadecki Hospital in Białystok Recruiting
Białystok, Poland, 15-950
Contact: Piotr Gałkin, M.D.    +48601397139    piotr.galkin@anestezjolog.com.pl   
Department of Anesthesiology and Intensive Care, F. Chopin Hospital in Rzeszów Recruiting
Rzeszów, Poland, 35-055
Contact: Patrycja Szajowska, M.D.    +48504068425    patrycjaguzek@poczta.onet.pl   
Sponsors and Collaborators
Medical University of Lublin
Department of Anesthesiology and Intensive Care, F. Chopin Hospital in Rzeszów
Department of Anesthesiology and Intensive Care, J. Śniadecki Hospital in Białystok
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Responsible Party: Michał Borys, M.D., Ph.D., Medical University of Lublin
ClinicalTrials.gov Identifier: NCT03529201    
Other Study ID Numbers: KE-0254/328/2017
First Posted: May 18, 2018    Key Record Dates
Last Update Posted: July 18, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Fentanyl
Oxycodone
Sevoflurane
Rocuronium
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents