Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Clinical Effectiveness of Erector Spinae Plane Block in Peri-operative Analgesia for Laparoscopic Nephrectomy/Nephron Sparing Surgery (NSS)/Hynes-Anderson Procedures.

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: NCT03874091
Recruitment Status : Recruiting
First Posted : March 14, 2019
Last Update Posted : March 14, 2019
Sponsor:
Information provided by (Responsible Party):
Medical University of Warsaw

Brief Summary:
62 patients age of 20 to 85, (ASA) physical status I-III undergoing laparoscopic nephrectomy/NSS/Hynes Anderson procedures 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 Anaesthesia (GA) with intravenous analgesia peri-operatively, patients from the second group will receive GA plus the Erector Spinae Plane Block (ESP block) bilaterally 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 for each side. 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 Procedure: bilateral ESP block with 0,25% Bupivacaine+ Adrenaline Procedure: ESP block continuous infusion with 0,125% Bupivacaine+Adrenaline Drug: Morphine PCA pump Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 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 Laparoscopic Nephrectomy/NSS/Hynes-Anderson Procedures
Actual Study Start Date : January 15, 2019
Estimated Primary Completion Date : May 28, 2019
Estimated Study Completion Date : July 15, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: GA group
Patients will receive general anaesthesia for laparoscopic nephrectomy/NSS/ Hynes Anderson procedures. 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.

Experimental: ESP group
Patients will receive general anaesthesia with bilateral ESP block for laparoscopic nephrectomy/NSS/ Hynes Anderson procedures. 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.
Procedure: bilateral ESP block with 0,25% Bupivacaine+ Adrenaline
Regional anaesthesia technique performed under ultrasound guidance before surgery

Procedure: ESP block continuous infusion with 0,125% Bupivacaine+Adrenaline
Continous infusion of Local Anaesthetic (LA) given postoperatively via the catheter.

Drug: Morphine PCA pump
Morphine given postoperatively.




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


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



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

Inclusion Criteria:

  • pts undergoing laparoscopic nephrectomy/NSS/Hynes Anderson procedures 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

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): NCT03874091


Contacts
Layout table for location contacts
Contact: Anna Roziewska 48 606932992 anna.roziewska@gmail.com
Contact: Lidia Jureczko, dr 48 501054419 jureczko@gmail.com

Locations
Layout table for location information
Poland
Warsaw University Center Recruiting
Warsaw, Poland, 02-005
Contact: Anna Roziewska    48606932992    anna.roziewska@gmail.com   
Sponsors and Collaborators
Medical University of Warsaw
Layout table for additonal information
Responsible Party: Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT03874091    
Other Study ID Numbers: MedUnivLapESPblock
First Posted: March 14, 2019    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: January 2019
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 Medical University of Warsaw:
Erector Spinae Plane block
ESP block
Laparoscopic Nephrectomy
Additional relevant MeSH terms:
Layout table for MeSH terms
Epinephrine
Racepinephrine
Morphine
Bupivacaine
Epinephryl borate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents