NCT03874091

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

January 15, 2019

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 21, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 14, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 7, 2020

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

November 16, 2021

Status Verified

March 1, 2020

Enrollment Period

1.6 years

First QC Date

January 21, 2019

Last Update Submit

November 15, 2021

Conditions

Erector Spinae Plane Block

Keywords

Erector Spinae Plane blockESP blockLaparoscopic Nephrectomy

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 (1)

  • Intraoperative Fentanyl Requirements

    Time of surgery.

Other Outcomes (1)

  • Postoperative Nausea and Vomiting (PONV)

    24 hours post surgery.

Study Arms (2)

GA group

ACTIVE COMPARATOR

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

ESP group

EXPERIMENTAL

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.

Procedure: bilateral ESP block with 0,25% Bupivacaine+ AdrenalineProcedure: ESP block continuous infusion with 0,125% Bupivacaine+AdrenalineDrug: Morphine PCA pump

Interventions

bilateral ESP block with 0,25% Bupivacaine+ AdrenalinePROCEDURE

Regional anaesthesia technique performed under ultrasound guidance before surgery

ESP group
ESP block continuous infusion with 0,125% Bupivacaine+AdrenalinePROCEDURE

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

ESP group
Morphine PCA pumpDRUG

Morphine given postoperatively.

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 laparoscopic nephrectomy/NSS/Hynes Anderson procedures 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 University Center

Warsaw, 02-005, Poland

Location

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

January 21, 2019

First Posted

March 14, 2019

Study Start

January 15, 2019

Primary Completion

September 7, 2020

Study Completion

October 1, 2021

Last Updated

November 16, 2021

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)