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

March 21, 2019 updated by: Medical University of Warsaw

Clinical Effectiveness of Erector Spinae Plane Block in Peri-operative Analgesia for Nephrectomy/NSS Performed Via Lumbotomy

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Poland
      • Warsaw, Poland, 02-005
        • Recruiting
        • Warsaw Clinical University Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 83 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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.
Drug: Fentanyl
Fentanyl administration during procedure, calculated per patient's weight and duration of surgery (minutes).
Other Names:
  • Fentanyl administration during surgery
Procedure: ESP block
Regional anaesthesia technique performed under ultrasound guidance before surgery
Other Names:
  • ESP block performed with 0,25% Marcaine+Adrenaline 1:200 000

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Morphine Requirements
Time Frame: 24 hours post surgery
Patient Controlled Analgesia (PCA) morphine consumption in both groups will be recorded.
24 hours post surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Time of surgery.
Postoperative Nausea and Vomiting (PONV) PONV PONV
Time Frame: 24 hours post surgery
Postoperative nausea and vomiting will be recorded if occurred
24 hours post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Warsaw

Collaborators

Warsaw Clinical University Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2019

Primary Completion (Anticipated)

July 20, 2019

Study Completion (Anticipated)

March 1, 2020

Study Registration Dates

First Submitted

March 11, 2019

First Submitted That Met QC Criteria

March 21, 2019

First Posted (Actual)

March 22, 2019

Study Record Updates

Last Update Posted (Actual)

March 22, 2019

Last Update Submitted That Met QC Criteria

March 21, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESPblockLumbotomy

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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