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

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

Study Overview

• Status: Completed
• Conditions: Erector Spinae Plane Block
• Intervention / Treatment: Drug: Morphine PCA pump; Procedure: bilateral ESP block with 0,25% Bupivacaine+ Adrenaline; Procedure: ESP block continuous infusion with 0,125% Bupivacaine+Adrenaline

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Warsaw, Poland, 02-005
    • Warsaw University Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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.	Drug: Morphine PCA pump; Morphine given postoperatively.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Morphine Requirements	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	Fentanyl consumption in both groups will be recorded	Time of surgery.

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Medical University of Warsaw

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2019
• Primary Completion (Actual): September 7, 2020
• Study Completion (Actual): October 1, 2021

Study Registration Dates

• First Submitted: January 21, 2019
• First Submitted That Met QC Criteria: March 11, 2019
• First Posted (Actual): March 14, 2019

Study Record Updates

• Last Update Posted (Actual): November 16, 2021
• Last Update Submitted That Met QC Criteria: November 15, 2021
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Erector Spinae Plane block; ESP block; Laparoscopic Nephrectomy
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Adrenergic alpha-Agonists; Adrenergic Agonists; Analgesics, Opioid; Narcotics; Anesthetics, Local; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Bupivacaine; Morphine; Epinephrine; Racepinephrine; Epinephryl borate
• Other Study ID Numbers: MedUnivLapESPblock

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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