Psoas Compartment Block (PCB) Versus L.A Infiltration and Remifentanil Infusion During EVAR

Comparative Study Between Psoas Compartment Block (PCB) Versus Local Anesthesia With Remifentanil Infusion for Endovascular Repair of Abdominal Aortic Aneurysm (EVAR): A Randomized Controlled Trial

Endovascular aneurysm repair (EVAR) was introduced in 1990 for the first time as a minimally invasive procedure instead of the conventional open surgical repair, with the aim to decrease morbidity and mortality . Nowadays EVAR has become an acceptable management for patients with infra-renal aortic aneurysms (AAA) . A lot of anesthetic techniques have been used successfully for EVAR. EVAR requires sedative analgesic medications to achieve an acceptable level of comfort to the patient and cardiorespiratory stability.

This is prospective randomized single blinded study of patients presenting with aorto-iliac aneurysm who will undergo EVAR. Patient's demographic data will be assessed, as well as clinical presentation, intraoperative complications.

30 patients undergoing elective EVAR will be included and will be divided equally into 2 groups.

First group is the psoas compartment block (PCB) (15 patients): 30 ml of bupivacaine 0.25% will be infused over 3 minutes at the anatomical landmark.

Second group is the LA and remifentanil group (LR) (15 patients): lidocaine 5 ml of 2% will be injected subcutaneous as local infiltration then remifentanil infusion with rate 0.03-0.1 μg kg-1 min-1. to achieve visual analog scale (VAS) 3 or less.

Vital date will be recorded as baseline then every 5 minutes till the end of the procedure. VAS will be recorded as baseline then every 5 minutes till the end of the procedure. Also stress response which will be measured subjectively as vital data and VAS and objectively as cortisol level in the blood which will be measured as base line and immediate after the end of the procedure.

Study Overview

• Status: Completed
• Conditions: Analgesic Adverse Reaction
• Intervention / Treatment: Procedure: Psoas Compartment Block (PCB); Drug: Normal saline 0.9% IV infusion; Procedure: Local Anesthesia infiltration; Drug: Remifentanil infusion

Detailed Description

Anatomical, imaging and clinical studies suggest that psoas compartment block (PCB) which was done at L2-L3 level has a high possibility to include L1-L2 roots, and thus can be suitable for inguinal surgery. In our study, the investigators introduce a modified PCB which will be performed in lateral decubitus by a 120 mm stimulated needle inserted at the junction between the lateral third and the medial two-thirds of a line drawn at L2-L3 interspace, between the interspinous line and a line passing through the posterior superior iliac spine (PSIS), parallel to the interspinous line . If twitching of the anterior thigh area is observed, the needle is moved slight cranially. When twitching of the inguinal field is observed, bupivacaine 0.5% 30 ml, will be injected

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• Saudi Arabia
  • Jeddah, Saudi Arabia, 0000
    • DR Erfan hospital
  • Jeddah, Saudi Arabia
    • Erfan hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All elective patients presenting with aortoiliac aneurysm who will undergo percutaneous EVAR.

Exclusion Criteria:

• Exclusion criteria included the presence of an aneurysm of the common femoral artery or severe atherosclerotic disease with total occlusion, emergency EVAR, uncooperative patient, patient on anticoagulation therapy, cerebrovascular disease, poorly controlled hypertension (systolic arterial pressure ≥160 mmHg), poorly controlled diabetes mellitus (random blood glucose ≥200 mg/dL) and renal insufficiency (creatinine >1.5 mg/dL).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Psoas Compartment Block (PCB); 30 ml of bupivacaine 0.25% will be infused over 3 minutes at the anatomical land mark for psoas plexus, also normal saline 0.9% IV infusion will be in the same rate of the Remifentanil infusion for the other group.	Procedure: Psoas Compartment Block (PCB); 30 ml of bupivacaine 0.25% will be infused over 3 minutes at the anatomical landmark for Psoas Compartment Block (PCB); Drug: Normal saline 0.9% IV infusion; Normal saline 0.9% IV infusion at the same rate of the Remifentanil infusion(0.05-0.1 μg/ kg/min).
Experimental: L.A infiltration /Remifentanil infusion; L.A infiltration (lidocaine) 5 ml of 2% will be injected subcutaneous as L.A infiltration then Remifentanil infusion with rate 0.03-0.1 μg / kg / min to achieve Visual Analog Scale 3 or less.	Procedure: Local Anesthesia infiltration; Lidocaine 5 ml of 2% will be injected subcutaneous as local infiltration.; Drug: Remifentanil infusion; Remifentanil infusion with rate 0.03-0.1 μg/ kg/ min to achieve Visual Analog Scale (VAS) 3 or less

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Visual Analogue Scale (VAS)	The primary outcome was Visual Analog Scale (VAS) to assess perioperative analgesia and pain management. Pain was assessed using the 100-mm visual analog scale, ranging from 0 to 100. The lowest score is 0 (no pain/excellent analgesia) and the highest score is 100 (Max pain).	Assessment to be done at baseline (immediate before starting the procedure), then every 10 min through study till 4 hours after given the anesthesia.The event was determent via asking patient about pain experience every time using 100 mm VAS

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arterial blood pressure	Arterial blood pressure monitoring in mmHg	will be recorded at baseline (immediate before starting the procedure), then every 5 min through study till 4 hours after given the anesthesia.
Satisfactions Score	Patient and surgeon satisfactions were assessed using the satisfaction score by asking them according to their degree of satisfaction based on this scale, which ranges from 0 to 100 (0 being the lowest score and 100 being the highest score).	Time frame include 2 time points, first time point: immediate at the end of the procedure and the second time point: 2 hours after the end of the procedure
heart rate (HR)	heart rate monitoring in beat / min	Will be recorded at baseline (immediate before starting the procedure), then every 5 min through study till 4 hours after given the anesthesia.
Oxygen saturation	Oxygen saturation monitoring in %	Will be recorded at baseline (immediate before starting the procedure), then every 5 min through study till 4 hours after given the anesthesia.

Collaborators and Investigators

• Sponsor: Dr. Erfan and Bagedo General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2018
• Primary Completion (Actual): November 10, 2018
• Study Completion (Actual): December 10, 2018

Study Registration Dates

• First Submitted: February 6, 2018
• First Submitted That Met QC Criteria: February 17, 2018
• First Posted (Actual): February 23, 2018

Study Record Updates

• Last Update Posted (Actual): February 18, 2019
• Last Update Submitted That Met QC Criteria: February 14, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: EVAR, analgesia
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Remifentanil
• Other Study ID Numbers: 180101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No