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

Sponsor

Medical University of Warsaw (Other)

Overall Status

Completed

CT.gov ID

NCT03874091

Collaborator

(none)

Enrollment

Location

Arms

32.5

Actual Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Erector Spinae Plane Block	Procedure: bilateral ESP block with 0,25% Bupivacaine+ Adrenaline Procedure: ESP block continuous infusion with 0,125% Bupivacaine+Adrenaline Drug: Morphine PCA pump	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

62 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Clinical Effectiveness of Erector Spinae Plane Block in Peri-operative Analgesia for Laparoscopic Kidney Procedures

Actual Study Start Date :

Jan 15, 2019

Actual Primary Completion Date :

Sep 7, 2020

Actual Study Completion Date :

Oct 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Drug: Morphine PCA pump Morphine given postoperatively.
Experimental: 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.	Procedure: bilateral ESP block with 0,25% Bupivacaine+ Adrenaline Regional anaesthesia technique performed under ultrasound guidance before surgery Procedure: ESP block continuous infusion with 0,125% Bupivacaine+Adrenaline Continous infusion of Local Anaesthetic (LA) given postoperatively via the catheter. Drug: Morphine PCA pump Morphine given postoperatively.

Arm

Intervention/Treatment

Active Comparator: 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.

Drug: Morphine PCA pump

Morphine given postoperatively.

Experimental: 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.

Procedure: bilateral ESP block with 0,25% Bupivacaine+ Adrenaline

Regional anaesthesia technique performed under ultrasound guidance before surgery

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

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

Drug: Morphine PCA pump

Morphine given postoperatively.

Outcome Measures

Primary Outcome Measures

Postoperative Morphine Requirements [24 hours post surgery]
Patient Controlled Analgesia (PCA) morphine consumption in both groups will be recorded.

Secondary Outcome Measures

Intraoperative Fentanyl Requirements [Time of surgery.]
Fentanyl consumption in both groups will be recorded

Other Outcome Measures

Postoperative Nausea and Vomiting (PONV) [24 hours post surgery.]
Postoperative nausea and vomiting will be recorded if occurred

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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