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

NCT03443518 | Completed Phase 2 DMC

• 1 other identifier: 180101
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Analgesic Adverse Reaction

Keywords

EVAR, analgesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Arterial blood pressure

  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

  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)

  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

  Will be recorded at baseline (immediate before starting the procedure), then every 5 min through study till 4 hours after given the anesthesia.

Study Arms (2)

Psoas Compartment Block (PCB)

EXPERIMENTAL

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); Drug: Normal saline 0.9% IV infusion

L.A infiltration /Remifentanil infusion

EXPERIMENTAL

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; Drug: Remifentanil infusion

Interventions

Psoas Compartment Block (PCB) PROCEDURE

30 ml of bupivacaine 0.25% will be infused over 3 minutes at the anatomical landmark for Psoas Compartment Block (PCB)

Psoas Compartment Block (PCB)

Local Anesthesia infiltration PROCEDURE

Lidocaine 5 ml of 2% will be injected subcutaneous as local infiltration.

L.A infiltration /Remifentanil infusion

Normal saline 0.9% IV infusion DRUG

Normal saline 0.9% IV infusion at the same rate of the Remifentanil infusion(0.05-0.1 μg/ kg/min).

Psoas Compartment Block (PCB)

Remifentanil infusion DRUG

Remifentanil infusion with rate 0.03-0.1 μg/ kg/ min to achieve Visual Analog Scale (VAS) 3 or less

L.A infiltration /Remifentanil infusion

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Dr. Erfan and Bagedo General Hospital: lead

Study Sites (2)

DR Erfan hospital

Jeddah, 0000, Saudi Arabia

Location

Erfan hospital

Jeddah, Saudi Arabia

Location

MeSH Terms

Conditions

Agnosia

Interventions

Anesthesia, Local; Saline Solution; Infusions, Intravenous

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Administration, Intravenous; Drug Administration Routes; Drug Therapy; Therapeutics; Infusions, Parenteral

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Physicians giving intraoperative care and recording data were blind to group type. Meanwhile, the anesthesiologist caring for the patient was aware to group type
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesia consultant

Study Record Dates

• First Submitted: February 6, 2018
• First Posted: February 23, 2018
• Study Start: February 6, 2018
• Primary Completion: November 10, 2018
• Study Completion: December 10, 2018
• Last Updated: February 18, 2019

Record last verified: 2019-02

Locations

SA (2)