NCT03887260

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2019

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

March 11, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 22, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2019

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

March 22, 2019

Status Verified

January 1, 2019

Enrollment Period

5 months

First QC Date

March 11, 2019

Last Update Submit

March 21, 2019

Conditions

Erector Spinae Plane Block

Outcome Measures

Primary Outcomes (1)

  • Postoperative Morphine Requirements

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

    24 hours post surgery

Secondary Outcomes (2)

  • Intraoperative Fentanyl Requirements

    Time of surgery.

  • Postoperative Nausea and Vomiting (PONV) PONV PONV

    24 hours post surgery

Study Arms (2)

GA group

ACTIVE COMPARATOR

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 pumpDrug: Fentanyl

ESP group

EXPERIMENTAL

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 pumpProcedure: ESP blockDrug: Fentanyl

Interventions

Morphine PCA pumpDRUG

Morphine given postoperatively.

ESP groupGA group
ESP blockPROCEDURE

Regional anaesthesia technique performed under ultrasound guidance before surgery

Also known as: ESP block performed with 0,25% Marcaine+Adrenaline 1:200 000
ESP group
FentanylDRUG

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

Also known as: Fentanyl administration during surgery
ESP groupGA group

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Pts without consent for trial
  • Pts ASA 4-5
  • Coagulation abnormalities
  • Allergy to local anesthetics
  • Skin lesions in the place of needle insertion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Warsaw Clinical University Center

Warsaw, 02-005, Poland

RECRUITING

MeSH Terms

Interventions

Fentanyl

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Central Study Contacts

Anna Roziewska

CONTACT

48 606932992anna.roziewska@gmail.com

Lidia Jureczko

CONTACT

48 501054419jureczko@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2019

First Posted

March 22, 2019

Study Start

March 1, 2019

Primary Completion

July 20, 2019

Study Completion

March 1, 2020

Last Updated

March 22, 2019

Record last verified: 2019-01

Locations

PL(1)