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

NCT ID: NCT03874091

Last Updated: 2021-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-15

Study Completion Date

2021-10-01

Brief Summary

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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.

Detailed Description

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Conditions

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Erector Spinae Plane Block

Keywords

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Erector Spinae Plane block ESP block Laparoscopic Nephrectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Morphine PCA pump

Intervention Type DRUG

Morphine given postoperatively.

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.

Group Type EXPERIMENTAL

bilateral ESP block with 0,25% Bupivacaine+ Adrenaline

Intervention Type PROCEDURE

Regional anaesthesia technique performed under ultrasound guidance before surgery

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

Intervention Type PROCEDURE

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

Morphine PCA pump

Intervention Type DRUG

Morphine given postoperatively.

Interventions

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bilateral ESP block with 0,25% Bupivacaine+ Adrenaline

Regional anaesthesia technique performed under ultrasound guidance before surgery

Intervention Type PROCEDURE

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

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

Intervention Type PROCEDURE

Morphine PCA pump

Morphine given postoperatively.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Warsaw

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Warsaw University Center

Warsaw, , Poland

Site Status

Countries

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Poland

Other Identifiers

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MedUnivLapESPblock

Identifier Type: -

Identifier Source: org_study_id