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

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ClinicalTrials.gov Identifier: NCT03443518
Recruitment Status : Completed
First Posted : February 23, 2018
Last Update Posted : February 18, 2019
Sponsor:
Information provided by (Responsible Party):
DR. Osama Mohamed Farahat, Dr. Erfan and Bagedo General Hospital

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.


Condition or disease Intervention/treatment Phase
Analgesic Adverse Reaction Procedure: Psoas Compartment Block (PCB) Procedure: Local Anesthesia infiltration Drug: Normal saline 0.9% IV infusion Drug: Remifentanil infusion Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: Physicians giving intraoperative care and recording data were blind to group type. Meanwhile, the anesthesiologist caring for the patient was aware to group type
Primary Purpose: Supportive Care
Official Title: 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
Actual Study Start Date : February 6, 2018
Actual Primary Completion Date : November 10, 2018
Actual Study Completion Date : December 10, 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Changes in Visual Analogue Scale (VAS) [ Time Frame: 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 ]

    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).



Secondary Outcome Measures :
  1. Arterial blood pressure [ Time Frame: will be recorded at baseline (immediate before starting the procedure), then every 5 min through study till 4 hours after given the anesthesia. ]
    Arterial blood pressure monitoring in mmHg

  2. Satisfactions Score [ Time Frame: 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 ]
    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).

  3. heart rate (HR) [ Time Frame: Will be recorded at baseline (immediate before starting the procedure), then every 5 min through study till 4 hours after given the anesthesia. ]
    heart rate monitoring in beat / min

  4. Oxygen saturation [ Time Frame: 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 monitoring in %



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03443518


Locations
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Saudi Arabia
DR Erfan hospital
Jeddah, Saudi Arabia, 0000
Erfan hospital
Jeddah, Saudi Arabia
Sponsors and Collaborators
Dr. Erfan and Bagedo General Hospital

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Responsible Party: DR. Osama Mohamed Farahat, Anesthesia consultant, Dr. Erfan and Bagedo General Hospital
ClinicalTrials.gov Identifier: NCT03443518     History of Changes
Other Study ID Numbers: 180101
First Posted: February 23, 2018    Key Record Dates
Last Update Posted: February 18, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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

Keywords provided by DR. Osama Mohamed Farahat, Dr. Erfan and Bagedo General Hospital:
EVAR, analgesia

Additional relevant MeSH terms:
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Anesthetics
Remifentanil
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents