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Ultrasound-guided Lumbar Erector Spinae Plane Block in Patients Undergoing Lower Limb Vascular Surgery

NCT ID: NCT04644562

Last Updated: 2020-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-20

Study Completion Date

2021-01-30

Brief Summary

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the investigatots hypothesized that by injection a larger volume and higher concentration of local anesthetic in lumbar erector spinae plane block could result in successful anesthesia in patient undergoing lower limb vascular surgery.

ultrasound-guided lumbar erector spinae plane block in patient undergoing lower limb vascular surgery with higher concentration of local anesthetic to asses it is efficacy as a sole anesthetic technique, it is safety and efficacy in maintaining intraoperative hemodynamics, intra and postoperative pain control .

Detailed Description

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The patients will placed in lateral position. After aseptic preparation of the skin and probe, a high-frequency linear ultrasound transducer will move about 3 cm laterally on the parasagittal plane to visualize the transverse process of the (L2) vertebra. An 18-guage tuohy needle will be approached in-plane lateral to medial. When the needle initially touched the transverse process of L3 vertebrae, the needle will be gently withdrawn and hydrodissection of the plane achieved, lifting the erector spinae muscle. A 20-guage catheter will be introduced through the needle and total length inserted will be 3 cm more than the tip of needle (. 25 mL of 0.5% bupivacaine ( in increments slowly after negative aspiration will be injected in the interfascial plane observing the anesthetic spread.

Sensory and motor block will be evaluated and surgery will begin only after adequate block , if failed, general anesthesia will induced by injecting 1.5-2 mg/kg propofol, 2 μg/kg fentanyl \& 0.5 mg/kg atracurium.

The patients will be ventilated via face mask with 100 % oxygen at a rate of 4 L/min and isoflurane 1.2 %. After 3 minutes, the patients will be intubated using appropriate sized cuffed oral tube lubricated with lidocaine jelly 2 % .

Maintenance of anesthesia will done using isoflurane 1.2 % in 100 % O2. Muscle relaxation will be continued by atracurium 0.1 mg/kg every 20 min. All patients will be mechanically ventilated to maintain end-tidal carbon dioxide between 35-40 mmHg. For 5 minutes, no surgical interventions will be allowed in the subjects to assess target blood pressure.

Conditions

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Anesthesia, Local

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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patients undergoing Lower Limb vascular Surgery

Ultrasound-guided lumbar Erector Spinae plane block in patients undergoing Lower Limb vascular Surgery

Group Type EXPERIMENTAL

Erector Spinae plane block

Intervention Type OTHER

Ultrasound-guided lumbar Erector Spinae plane block in patients undergoing Lower Limb vascular Surgery

Interventions

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Erector Spinae plane block

Ultrasound-guided lumbar Erector Spinae plane block in patients undergoing Lower Limb vascular Surgery

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

\- ASA II and III male and female patients undergoing lower limb vascular surgery

Exclusion Criteria

* Contraindications for regional blocks (eg. Patient refusal Infection at the injection site, coagulopathy)
* allergic reaction to drugs.
* opium addiction, any drug or substance abuse and chronic treatment with opium, non-steroidal anti-inflammatory drugs
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beni-Suef University

OTHER

Sponsor Role lead

Responsible Party

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doaa rashwan

Assistant professor Doaa Rashwan

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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doaa rashwan, md

Role: PRINCIPAL_INVESTIGATOR

Beni-Suef University

Locations

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Benisuef univercity

Banī Suwayf, Benisuef, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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doaa rashwan, md

Role: CONTACT

Phone: 00201011270763

Email: [email protected]

Facility Contacts

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Doaa Rashwan, MD

Role: primary

Samaa Rashwan, MD Rashwan, MD

Role: backup

Other Identifiers

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FMBSUREC/05072020/Abd El Badei

Identifier Type: -

Identifier Source: org_study_id