AnalgesiaNCT04264689
Perioperative Thoracotomy Analgesia; Different Analgesic Modalities
A study testing serratus anterior block, thoracic epidural and erector spinae block in people with Analgesia, run by National Cancer Institute, Egypt at 1 site in Egypt.
Trial summary
the study aim is to compare the analgesic effect of thoracic epidural versus serratus plane block versus erector spinae block in thoracic surgeries Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Analgesia
- What is being tested?
- serratus anterior block, thoracic epidural and erector spinae block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Mar 2020to 3 Nov 2020
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients scheduled for thoracotomy age 18-65
Who cannot join
- patient refusal coagulation defects abnormal kidney or liver functions local infection at site of block bone metastases
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Department of anesthesia and pain medicine. National Cancer Institute
Cairo, 11796
About this study
the study aim is to compare the analgesic effect of thoracic epidural versus serratus plane block versus erector spinae block in thoracic surgeries
Read the detailed description
comparing the analgesic effect of thoracic epidural versus serratus plane block versus erector spinae block in thoracic surgeries regarding pain control and possible side effects
- Conditions
- Analgesia
- Being tested
- serratus anterior block, thoracic epidural, erector spinae block
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serratus anterior blockProcedure or surgery
ultrasound guided block
thoracic epiduralProcedure or surgery
thoracic epidural
erector spinae blockProcedure or surgery
ultrasound guided block
| Study group | Role | What they receive |
|---|---|---|
| thoracic epidural | Active comparator | thoracic epidural will be done before induction of general anesthesia Receives: Procedure: thoracic epidural |
| serratus anterior block | Experimental | ultrasound guided serratus anterior block will be done after induction of general anesthesia Receives: Procedure: serratus anterior block |
| erector spinae block | Experimental | ultrasound guided erector spinae block will be done after induction of general anesthesia Receives: Procedure: erector spinae block |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analogue score
minimum value 0 and maximum value 10
Measured: 24 hours
Secondary outcomes (1)
mean arterial blood pressure
measurement of mean arterial blood pressure
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 posted11 Feb 2020
- Study start2 Mar 2020
- Primary completion28 Oct 2020
- Study completion3 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Walaa Youssef Elsabeeny, National Cancer Institute, Egypt
- Investigators
- walaa Y elsabeeny, MD, Principal investigator, Lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04264689
- Sponsor's protocol ID
- AP1906-50105
- Status last verified
- Dec 2020
- First submitted
- 9 Feb 2020
- Last updated
- 7 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Thoracotomy Analgesia; Different Analgesic Modalities
- ClinicalTrials.gov ID
- NCT04264689
- Acronym / sponsor ID
- AP1906-50105
- Conditions
- Analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- National Cancer Institute, EgyptUniversity, hospital or other
- Study start
- 2 Mar 2020 (actual)
- Primary completion
- 28 Oct 2020 (actual)
- Study completion
- 3 Nov 2020 (actual)
- First posted
- 11 Feb 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 study aim is to compare the analgesic effect of thoracic epidural versus serratus plane block versus erector spinae block in thoracic surgeries
Detailed description
comparing the analgesic effect of thoracic epidural versus serratus plane block versus erector spinae block in thoracic surgeries regarding pain control and possible side effects
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| thoracic epidural | Active comparator | Procedure: thoracic epiduralthoracic epidural will be done before induction of general anesthesia |
| serratus anterior block | Experimental | Procedure: serratus anterior blockultrasound guided serratus anterior block will be done after induction of general anesthesia |
| erector spinae block | Experimental | Procedure: erector spinae blockultrasound guided erector spinae block will be done after induction of general anesthesia |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients scheduled for thoracotomy age 18-65
Key exclusion criteria (1 listed)
- patient refusal coagulation defects abnormal kidney or liver functions local infection at site of block bone metastases
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 |
|---|---|---|
| serratus anterior blockultrasound guided block | Procedure or surgery | serratus anterior block |
| thoracic epiduralthoracic epidural | Procedure or surgery | thoracic epidural |
| erector spinae blockultrasound guided block | Procedure or surgery | erector spinae block |
Primary outcome
visual analogue score
Time frame: 24 hours
minimum value 0 and maximum value 10
1 secondary outcome
mean arterial blood pressure
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 7 Dec 2020.
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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.
walaa Y elsabeeny, MD principal investigator
Lecturer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing serratus anterior block, thoracic epidural and erector spinae block in people with Analgesia, run by National Cancer Institute, Egypt 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 1 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 7 Dec 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?
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?
visual analogue score (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 7 Dec 2020.