Postoperative AnalgesiaNCT04579302
Serratus Anterior Block and Erector Spinae Block in Postoperative Analgesia
A study testing Serratus anterior block (SAB), Erector spinae block and Bupivacaine in people with Postoperative Analgesia, run by National Cancer Institute, Egypt at 1 site in Egypt.
Trial summary
90 patients scheduled for thoracic cancer surgeries, allocated in 3 groups for serratus anterior block and erector spinae block and control group. during anaesthesia:total intraoperative fentanyl required will be recorded. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Postoperative Analgesia
- What is being tested?
- Serratus anterior block (SAB), Erector spinae block and Bupivacaine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2020to 28 Feb 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with class II physical status (American Society of Anaesthesiologists) ,
- Age between 18-70 years,
- Scheduled for thoracic cancer surgery
Who cannot join
- Patient refusal.
- Local infection at the site of the block.
- Cardiac dysfunction (ejection fraction <45%).
- Significant respiratory disorders.
- Preexisting neurological or psychiatric disease.
- Allergy to one of the study drugs.
- Pregnancy.
- Coagulopathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effect of Serratus Anterior Block and Erector Spinae Block on Postoperative Analgesia in Thoracic Surgeries
90 patients scheduled for thoracic cancer surgeries, allocated in 3 groups for serratus anterior block and erector spinae block and control group. during anaesthesia:total intraoperative fentanyl required will be recorded. After surgery, all patients will be connected to PCA device containing morphine solution, the amount of morphine consumed during the first 24 hours will be recorded.
Read the detailed description
90 patients scheduled for thoracic cancer surgeries, allocated in 3 groups for serratus anterior block (SAB) and erector spinae block (ESB) and control group. During anaesthesia: total intraoperative fentanyl required will be recorded. After surgery, all patients will be connected to PCA device containing morphine solution, the amount of morphine consumed during the first 24 hours will be recorded. Other secondary outcomes are: numerical rating scales and postoperative pulmonary functions.
- Conditions
- Postoperative Analgesia
- Being tested
- Serratus anterior block (SAB), Erector spinae block, Saline (as a placebo), Bupivacaine
- Keywords
- Serratus anterior block, Erector spinae block, Postoperative analgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serratus anterior block (SAB)Procedure or surgery
Also called SAB group
Patients will receive a sonar guided serratus anterior plane block with 20 ml of bupivacaine 0.5%
Erector spinae blockProcedure or surgery
Also called ESB group
Patients will receive a sonar-guided erector spinae plane block with 20 ml of bupivacaine 0.5%
Saline (as a placebo)Drug
Patients will receive a sham block with 20 ml saline (as a placebo)
BupivacaineDrug
bupivacaine
| Study group | Role | What they receive |
|---|---|---|
| serratus anterior block | Experimental | serratus anterior block with 20 ml bupivacaine Receives: Procedure: Serratus anterior block (SAB); Drug: Bupivacaine |
| erector spinae block | Experimental | erector spinae block with 20 ml bupivacaine Receives: Procedure: Erector spinae block; Drug: Bupivacaine |
| control group | Sham comparator | sham block with 20 ml saline Receives: Drug: Saline (as a placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
total morphine consumption in first postoperative 24 hours
the amount of morphine required to relieve pain will be recorded
Measured: first 24 postoperative hours
Secondary outcomes (3)
intraoperative fentanyl requirement
the amount of fentanyl required during anaesthesia will be recorded
Measured: during anaesthesia
numerical rating scale
numerical rating scale (from 0 to 10, where 0 represents no pain and 10 represents the worst imaginable pain) will be recorded in different time intervals during the first 24 hours after surgery
Measured: the first 24 postoperative hours
pulmonary functions
FVC and FEV1 will be recorded at 24 hours after surgery
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start1 Nov 2020
- Primary completion28 Feb 2021
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohamed E Hassan, MS, Principal investigator, National Cancer Institute - Vairo University - Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04579302
- Sponsor's protocol ID
- AP2007-50105
- Status last verified
- Mar 2021
- First submitted
- 24 Sep 2020
- Last updated
- 9 Mar 2021
- 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 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Serratus Anterior Block and Erector Spinae Block on Postoperative Analgesia in Thoracic Surgeries
- ClinicalTrials.gov ID
- NCT04579302
- Acronym / sponsor ID
- AP2007-50105
- Conditions
- Postoperative Analgesia
- Keywords
- Serratus anterior block, Erector spinae block, Postoperative analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- National Cancer Institute, EgyptUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 8 Oct 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.
90 patients scheduled for thoracic cancer surgeries, allocated in 3 groups for serratus anterior block and erector spinae block and control group. during anaesthesia:total intraoperative fentanyl required will be recorded. After surgery, all patients will be connected to PCA device containing morphine solution, the amount of morphine consumed during the first 24 hours will be recorded.
Detailed description
90 patients scheduled for thoracic cancer surgeries, allocated in 3 groups for serratus anterior block (SAB) and erector spinae block (ESB) and control group. During anaesthesia: total intraoperative fentanyl required will be recorded. After surgery, all patients will be connected to PCA device containing morphine solution, the amount of morphine consumed during the first 24 hours will be recorded. Other secondary outcomes are: numerical rating scales and postoperative pulmonary functions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| serratus anterior block | Experimental | Procedure: Serratus anterior block (SAB), Drug: Bupivacaineserratus anterior block with 20 ml bupivacaine |
| erector spinae block | Experimental | Procedure: Erector spinae block, Drug: Bupivacaineerector spinae block with 20 ml bupivacaine |
| control group | Sham comparator | Drug: Saline (as a placebo)sham block with 20 ml saline |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with class II physical status (American Society of Anaesthesiologists) ,
- Age between 18-70 years,
- Scheduled for thoracic cancer surgery
Key exclusion criteria (8 listed)
- Patient refusal.
- Local infection at the site of the block.
- Cardiac dysfunction (ejection fraction <45%).
- Significant respiratory disorders.
- Preexisting neurological or psychiatric disease.
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 block (SAB)Also: SAB groupPatients will receive a sonar guided serratus anterior plane block with 20 ml of bupivacaine 0.5% | Procedure or surgery | serratus anterior block |
| Erector spinae blockAlso: ESB groupPatients will receive a sonar-guided erector spinae plane block with 20 ml of bupivacaine 0.5% | Procedure or surgery | erector spinae block |
| Saline (as a placebo)Patients will receive a sham block with 20 ml saline (as a placebo) | Drug | control group |
| Bupivacainebupivacaine | Drug | erector spinae block, serratus anterior block |
Primary outcome
total morphine consumption in first postoperative 24 hours
Time frame: first 24 postoperative hours
the amount of morphine required to relieve pain will be recorded
3 secondary outcomes
intraoperative fentanyl requirement
Time frame: during anaesthesia
numerical rating scale
Time frame: the first 24 postoperative hours
pulmonary functions
Time frame: 24 hours after surgery
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 9 Mar 2021.
- 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.
Mohamed E Hassan, MS principal investigator
National Cancer Institute - Vairo University - Egypt
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 (SAB), Erector spinae block and Bupivacaine in people with Postoperative 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 3 inclusion and 8 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 9 Mar 2021. 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?
total morphine consumption in first postoperative 24 hours (time frame: first 24 postoperative 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 9 Mar 2021.