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

Erector Spinae Plane Block Clinical Trial

Official title:

Clinical Effectiveness of Erector Spinae Plane Block in Peri-operative Analgesia for Nephrectomy/NSS Performed Via Lumbotomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03887260
• Other study ID #: ESPblockLumbotomy
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: March 1, 2020

Study information

• Verified date: January 2019
• Source: Medical University of Warsaw
• Contact: Anna Roziewska
• Phone: 48 606932992
• Email: anna.roziewska[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: March 1, 2020
• Est. primary completion date: July 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Erector Spinae Plane Block

Intervention

Drug:
• Morphine PCA pump
Morphine given postoperatively.

Procedure:
• ESP block
Regional anaesthesia technique performed under ultrasound guidance before surgery

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

Locations

Country	Name	City	State
Poland	Warsaw Clinical University Center	Warsaw

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Warsaw	Warsaw Clinical University Center

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative Morphine Requirements	Patient Controlled Analgesia (PCA) morphine consumption in both groups will be recorded.	24 hours post surgery
Secondary	Intraoperative Fentanyl Requirements	Fentanyl consumption in both groups will be recorded ( ug of fentanyl given intraoperatively divided by patients weight in kg and minutes of surgery)	Time of surgery.
Secondary	Postoperative Nausea and Vomiting (PONV) PONV PONV	Postoperative nausea and vomiting will be recorded if occurred	24 hours post surgery