Hemodynamic InstabilityNCT04371705
Efficacy of Ultrasound Guided Erector Spinae Plane Block
A study testing Erector spinae plane block in people with Hemodynamic Instability and Patient Satisfaction, run by Minia University at 1 site in Egypt.
Trial summary
Thoracic epidural and paravertebral blocks are the most widely regional technique used for postoperative analgesia after surgery, but they are difficult to perform and carry a risk of serious complication. Read more about this study
- Who is it for?
- Ages 25 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemodynamic Instability, Patient Satisfaction, Postoperative Pain
- What is being tested?
- Erector spinae plane block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Oct 2018to 1 Dec 2019
- 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 25 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age18-70 .
- Both gender.
- 4. ASA I-III .
Who cannot join
- patient refuse
- Drug allergy.
- Morbid obesity (BMI >40 kg/m2).
- Psychiatric disorder.
- Opioid dependence .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Ultrasound Guided Erector Spinae Plane Block in Patients Undergoning Abdominal Surgery
Thoracic epidural and paravertebral blocks are the most widely regional technique used for postoperative analgesia after surgery, but they are difficult to perform and carry a risk of serious complication. In this study, investigator asses the efficacy of ultrasound ESPB on intraoperative and postoperative hemodynamics and patient satisfaction
Read the detailed description
This prospective, double-blinded, randomized, controlled study was conducted at the period from October 2018 to December 2019. Sixty adults' patients ASA I-III, their ages ranged from 25-60 years undergoing abdominal surgery under general anesthesia. Each patient assigned written informed consent before the block performance.
Patients refused, known allergy to the used drugs, with history of coagulopathy, major organ failure and obesity (BMI>40 kg/m2) were excluded from the study.
Patients were randomly allocated into two equal groups by a computerized randomization table: ESPB group, and control group. The patient and the staff providing the postoperative care were blinded to the group assignment.
ESPB group: Will undergo ESP block with 40 ml bupivacaine 0.25% (20 ml on each side) control group: anesthetized with the protocol followed by Minia University Hospital.
Anesthetic technique was standardized for all patients.
- Being tested
- Erector spinae plane block, control
- Keywords
- ESPB, postoperative pain, Regional block
- Medical subject headings
- Patient Satisfaction, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector spinae plane blockProcedure or surgery
The ESP block will be performed into a fascial plane between the deep surface of erector spinae muscle and the transverse processes using ultrasound guide.
controlOther
placebo
| Study group | Role | What they receive |
|---|---|---|
| ESPB group | Experimental | 31 patients Will undergo ultrasound guided ESP block with 40 ml bupivacaine 0.25% (20 ml on each side). Receives: Procedure: Erector spinae plane block |
| control group | Placebo comparator | 31 patients anesthetized with the protocol followed by Minia University Hospital Receives: Other: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Total Fentanyl Requirement
The total amount of postoperative fentanyl in milligram
Measured: 24 hours
Secondary outcomes (3)
Time of First Post Operative Analgesic Request
the pain will be assisted based on the time for the first dose of rescue analgesia.
Measured: 24 hours
heart rate (HR)
Hemodynamic
Measured: 24 hours
mean arterial pressure (MAP )
Hemodynamic
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2020
- Study start15 Oct 2018
- Primary completion1 Dec 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodynamic InstabilityStudies of the same condition, open and under way.
- More trials run by Minia 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hassan Mokhtar Elshorbagy Hetta, Minia University
- Investigators
- Nagy S. Ali, MD, Study chair, Minia University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04371705
- Sponsor's protocol ID
- Efficacy of ESPB
- Status last verified
- May 2020
- First submitted
- 27 Apr 2020
- Last updated
- 6 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Ultrasound Guided Erector Spinae Plane Block in Patients Undergoning Abdominal Surgery
- ClinicalTrials.gov ID
- NCT04371705
- Acronym / sponsor ID
- Efficacy of ESPB
- Keywords
- ESPB, postoperative pain, Regional block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 1 May 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.
Thoracic epidural and paravertebral blocks are the most widely regional technique used for postoperative analgesia after surgery, but they are difficult to perform and carry a risk of serious complication. In this study, investigator asses the efficacy of ultrasound ESPB on intraoperative and postoperative hemodynamics and patient satisfaction
Detailed description
This prospective, double-blinded, randomized, controlled study was conducted at the period from October 2018 to December 2019. Sixty adults' patients ASA I-III, their ages ranged from 25-60 years undergoing abdominal surgery under general anesthesia. Each patient assigned written informed consent before the block performance.
Patients refused, known allergy to the used drugs, with history of coagulopathy, major organ failure and obesity (BMI>40 kg/m2) were excluded from the study.
Patients were randomly allocated into two equal groups by a computerized randomization table: ESPB group, and control group. The patient and the staff providing the postoperative care were blinded to the group assignment.
ESPB group: Will undergo ESP block with 40 ml bupivacaine 0.25% (20 ml on each side) control group: anesthetized with the protocol followed by Minia University Hospital.
Anesthetic technique was standardized for all patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESPB group | Experimental | Procedure: Erector spinae plane block31 patients Will undergo ultrasound guided ESP block with 40 ml bupivacaine 0.25% (20 ml on each side). |
| control group | Placebo comparator | Other: control31 patients anesthetized with the protocol followed by Minia University Hospital |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age18-70 .
- Both gender.
- 4. ASA I-III .
Key exclusion criteria (5 listed)
- patient refuse
- Drug allergy.
- Morbid obesity (BMI >40 kg/m2).
- Psychiatric disorder.
- Opioid dependence .
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 blockThe ESP block will be performed into a fascial plane between the deep surface of erector spinae muscle and the transverse processes using ultrasound guide. | Procedure or surgery | ESPB group |
| controlplacebo | Other | control group |
Primary outcome
Postoperative Total Fentanyl Requirement
Time frame: 24 hours
The total amount of postoperative fentanyl in milligram
3 secondary outcomes
Time of First Post Operative Analgesic Request
Time frame: 24 hours
heart rate (HR)
Time frame: 24 hours
mean arterial pressure (MAP )
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2020.
- Individual participant dataSharing planned: No
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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.
Nagy S. Ali, MD study chair
Minia University Hospital
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 Hemodynamic Instability and Patient Satisfaction, run by Minia 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 6 May 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Total Fentanyl Requirement (time frame: 24 hours). 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 6 May 2020.