Anesthesia, LocalNCT04644562
Ultrasound-guided Lumbar Erector Spinae Plane Block in Patients Undergoing Lower Limb Vascular Surgery
A study testing Erector Spinae plane block in people with Anesthesia, Local, run by Beni-Suef University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Anesthesia, Local
- What is being tested?
- Erector Spinae plane block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Nov 2020to 30 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA II and III male and female patients undergoing lower limb vascular surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Benisuef univercity
Banī Suwayf, Benisuef, 62511
Doaa Rashwan, MD, 01011270763, doaa_rashwan@hotmail.com
Samaa Rashwan, MD Rashwan, MD
About this study
Official title: The Anaesthetic and Analgesic Efficacy of Ultrasound-guided Lumbar Erector Spinae Plane Block in Patients Undergoing Lower Limb Vascular Surgery
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 .
Read the detailed description
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
- Anesthesia, Local
- Being tested
- Erector Spinae plane block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector Spinae plane blockOther
Ultrasound-guided lumbar Erector Spinae plane block in patients undergoing Lower Limb vascular Surgery
| Study group | Role | What they receive |
|---|---|---|
| patients undergoing Lower Limb vascular Surgery | Experimental | Ultrasound-guided lumbar Erector Spinae plane block in patients undergoing Lower Limb vascular Surgery Receives: Other: Erector Spinae plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
motor block block level
motor power
Measured: baseline, pre-intervention/procedure/surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2020
- Study start20 Nov 2020 (estimated)
- Primary completion30 Jan 2021 (estimated)
- Study completion30 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, LocalStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, doaa rashwan, Beni-Suef University
- Investigators
- doaa rashwan, md, Principal investigator, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04644562
- Sponsor's protocol ID
- FMBSUREC/05072020/Abd El Badei
- Status last verified
- Nov 2020
- First submitted
- 17 Jul 2020
- Last updated
- 25 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Anaesthetic and Analgesic Efficacy of Ultrasound-guided Lumbar Erector Spinae Plane Block in Patients Undergoing Lower Limb Vascular Surgery
- ClinicalTrials.gov ID
- NCT04644562
- Acronym / sponsor ID
- FMBSUREC/05072020/Abd El Badei
- Conditions
- Anesthesia, Local
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 20 Nov 2020 (estimated)
- Primary completion
- 30 Jan 2021 (estimated)
- Study completion
- 30 Jan 2021 (estimated)
- First posted
- 25 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients undergoing Lower Limb vascular Surgery | Experimental | Other: Erector Spinae plane blockUltrasound-guided lumbar Erector Spinae plane block in patients undergoing Lower Limb vascular Surgery |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA II and III male and female patients undergoing lower limb vascular surgery
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Erector Spinae plane blockUltrasound-guided lumbar Erector Spinae plane block in patients undergoing Lower Limb vascular Surgery | Other | patients undergoing Lower Limb vascular Surgery |
Primary outcome
motor block block level
Time frame: baseline, pre-intervention/procedure/surgery
motor power
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
doaa rashwan, md principal investigator
Beni-Suef University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erector Spinae plane block in people with Anesthesia, Local, run by Beni-Suef University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact doaa rashwan, md (00201011270763, doaa_rashwan@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
motor block block level (time frame: baseline, pre-intervention/procedure/surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2020.