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Completed

NCT Number: NCT03874091

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

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.

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Key information

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Warsaw University Center

Warsaw, 02-005, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bilateral ESP block with 0,25% Bupivacaine+ Adrenaline

Procedure

Regional anaesthesia technique performed under ultrasound guidance before surgery

ESP block continuous infusion with 0,125% Bupivacaine+Adrenaline

Procedure

Continous infusion of Local Anaesthetic (LA) given postoperatively via the catheter.

Morphine PCA pump

Drug

Morphine given postoperatively.

Primary outcomes

  1. Postoperative Morphine Requirements

    Time frame: 24 hours post surgery

    Patient Controlled Analgesia (PCA) morphine consumption in both groups will be recorded.

Secondary outcomes

  1. Intraoperative Fentanyl Requirements

    Time frame: Time of surgery.

    Fentanyl consumption in both groups will be recorded

Other outcomes

  1. Postoperative Nausea and Vomiting (PONV)

    Time frame: 24 hours post surgery.

    Postoperative nausea and vomiting will be recorded if occurred

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Registry information

Official study title

Clinical Effectiveness of Erector Spinae Plane Block in Peri-operative Analgesia for Laparoscopic Kidney Procedures

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Mar 14, 2019
Registry last updated
Nov 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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