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Clinical Effectiveness of Erector Spinae Plane Block in Peri-operative Analgesia for Nephrectomy/Nephron Sparing Surgery(NSS) Performed Via Lumbotomy

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ClinicalTrials.gov Identifier: NCT03887260
Recruitment Status : Unknown
Verified January 2019 by Medical University of Warsaw.
Recruitment status was:  Recruiting
First Posted : March 22, 2019
Last Update Posted : March 22, 2019
Sponsor:
Collaborator:
Warsaw Clinical University Center
Information provided by (Responsible Party):
Medical University of Warsaw

Study Description
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Brief Summary:
42 patients age of 20 to 85, (ASA) physical status I-III undergoing nephrectomy/NSS procedures via lumbotomy in 1st Department of Anesthesiology in Warsaw will be enrolled in the study. Patients will be randomised into 2 groups - patients from the first group will undergo General Anesthesia (GA) with intravenous analgesia peri-operatively, patients from the second group will receive GA plus the Erector Spinae Plane Block (ESP block) unilaterally performed under ultrasound guidance with catheter left on the side of surgery. Ultrasound transducer will be placed in a longitudinal orientation 3 cm lateral to the Th7 spinous process. Three muscles will be identified superficial to the hyperechogenic transverse process shadow as follows: trapezius, rhomboid major, and erector spinae. An 8-cm 18-gauge block needle will be inserted in a cephalad-to-caudad direction until the tip gets in the interfascial plane between rhomboid major and erector spinae muscles, as evidenced by visualization of local anesthetic spreading in a linear pattern between erector spinae and the bony acoustic shadows of the transverse processes. . Patients in this group will be anesthetized with 20ml 0,25% bupivacaine + Adrenaline 1:200 000 via interfascial catheter. ESP block will be performed at the level of Th7-8 after proper positioning he patient in the sitting position before GA then standard technique of catheter application will be applied. After the surgery the elastomeric pump will be attached to the catheter with 0,125% bupivacaine with Adrenaline 1:200 000. Anaesthesia will be standardised In the both groups.

Condition or disease Intervention/treatment Phase
Erector Spinae Plane Block Drug: Morphine PCA pump Procedure: ESP block Drug: Fentanyl Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Clinical Effectiveness of Erector Spinae Plane Block in Peri-operative Analgesia for Nephrectomy/NSS Performed Via Lumbotomy
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : July 20, 2019
Estimated Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: GA group
Patients will receive general anaesthesia for nephrectomy/NSS procedures via lumbotomy. Analgesia will be provided by titration of fentanyl during surgery. An intravenous patient controlled morphine pump will be used postoperatively.
 Drug: Morphine PCA pump
Morphine given postoperatively.

Drug: Fentanyl
Fentanyl administration during procedure, calculated per patient's weight and duration of surgery (minutes).
Other Name: Fentanyl administration during surgery
Experimental: ESP group
Patients will receive general anaesthesia with ESP block for nephrectomy/NSS procedures via lumbotomy. Catheter will be inserted in the erector spinae plane on the side of surgery. Postoperatively patients will get continuous infusion of 0,125% Bupivacaine+Adrenaline to the catheter for 24h and PCA morphine pump intravenously.
 Drug: Morphine PCA pump
Morphine given postoperatively.

Procedure: ESP block
Regional anaesthesia technique performed under ultrasound guidance before surgery
Other Name: ESP block performed with 0,25% Marcaine+Adrenaline 1:200 000

Drug: Fentanyl
Fentanyl administration during procedure, calculated per patient's weight and duration of surgery (minutes).
Other Name: Fentanyl administration during surgery


Outcome Measures
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Primary Outcome Measures :
  1. Postoperative Morphine Requirements [ Time Frame: 24 hours post surgery ]
    Patient Controlled Analgesia (PCA) morphine consumption in both groups will be recorded.


Secondary Outcome Measures :
  1. Intraoperative Fentanyl Requirements [ Time Frame: Time of surgery. ]
    Fentanyl consumption in both groups will be recorded ( ug of fentanyl given intraoperatively divided by patients weight in kg and minutes of surgery)

  2. Postoperative Nausea and Vomiting (PONV) PONV PONV [ Time Frame: 24 hours post surgery ]
    Postoperative nausea and vomiting will be recorded if occurred


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pts undergoing nephrectomy/NSS procedures via lumbotomy in 1st Department of Anaesthesiology in Warsaw
  • Pts consented for the study prior to surgery
  • ASA 1-3

Exclusion Criteria:

  • Pts without consent for trial
  • Pts ASA 4-5
  • Coagulation abnormalities
  • Allergy to local anesthetics
  • Skin lesions in the place of needle insertion
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): NCT03887260


Contacts
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Contact: Anna Roziewska 48 606932992 anna.roziewska@gmail.com
Contact: Lidia Jureczko 48 501054419 jureczko@gmail.com

Locations
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Poland
Warsaw Clinical University Center Recruiting
Warsaw, Poland, 02-005
Contact: Anna Roziewska    48606932992    anna.roziewska@gmail.com   
Sponsors and Collaborators
Medical University of Warsaw
Warsaw Clinical University Center
More Information
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Responsible Party: Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT03887260    
Other Study ID Numbers: ESPblockLumbotomy
First Posted: March 22, 2019    Key Record Dates
Last Update Posted: March 22, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fentanyl
Morphine
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