NCT03443518

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

Completed Phase 2 Last updated 18 February 2019

What this trial tests

Phase 2 trial testing Psoas Compartment Block (PCB) in Analgesic Adverse Reaction in 30 participants. Completed in 10 December 2018.

Timeline

6 February 2018

Primary endpoint
10 November 2018

10 December 2018

Quick facts

Lead sponsor	Dr. Erfan and Bagedo General Hospital
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	supportive care
Enrollment	30
Start date	6 February 2018
Primary completion	10 November 2018
Estimated completion	10 December 2018
Sites	2 locations across Saudi Arabia

Drugs / interventions tested

• Psoas Compartment Block (PCB)
• Local Anesthesia infiltration — full drug profile →
• Normal saline 0.9% IV infusion — full drug profile →
• Remifentanil infusion — full drug profile →

Conditions studied

• Analgesic Adverse Reaction — all drugs for Analgesic Adverse Reaction →

Sponsor

Dr. Erfan and Bagedo General Hospital

Who can join

Eligibility, any sex, with Analgesic Adverse Reaction. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.