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

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2020-03-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Erector Spinae Plane Block

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 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.

Group Type ACTIVE_COMPARATOR

Morphine PCA pump

Intervention Type DRUG

Morphine given postoperatively.

Fentanyl

Intervention Type DRUG

Fentanyl administration during procedure, calculated per patient's weight and duration of surgery (minutes).

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.

Group Type EXPERIMENTAL

Morphine PCA pump

Intervention Type DRUG

Morphine given postoperatively.

ESP block

Intervention Type PROCEDURE

Regional anaesthesia technique performed under ultrasound guidance before surgery

Fentanyl

Intervention Type DRUG

Fentanyl administration during procedure, calculated per patient's weight and duration of surgery (minutes).

Interventions

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Morphine PCA pump

Morphine given postoperatively.

Intervention Type DRUG

ESP block

Regional anaesthesia technique performed under ultrasound guidance before surgery

Intervention Type PROCEDURE

Fentanyl

Fentanyl administration during procedure, calculated per patient's weight and duration of surgery (minutes).

Intervention Type DRUG

Other Intervention Names

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ESP block performed with 0,25% Marcaine+Adrenaline 1:200 000 Fentanyl administration during surgery

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No