AnalgesiaNCT05514977
Ultrasound Guided Thoracic ESPB for Post Mastectomy Pain Control, Comparing 2 Dosing Regimens of Lidocaine With Different Drug Volumes
A study testing Erector spine plane block in people with Analgesia, run by Cairo University at 1 site in Egypt.
Trial summary
The investigators compare 2 different drug regimens using 2 different volumes of lidocaine with the same drug content (i.e. different concentrations) as regards efficacy of post operative analgesia following mastectomy surgery Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Analgesia
- What is being tested?
- Erector spine plane block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2022to 30 Dec 2022
- 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
- ASA 2 \& 3 for elective breast cancer surgery
Who cannot join
- ASA > 3
- BMI > 35 kg/m2
- Contraindications to LA (coagulopathy and local infection)
- Allergy to the drug
- Cardiac, hepatic and renal patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound Guided Thoracic Erector Spine Plane Block for Post Mastectomy Pain Control, Effect of Volume With Constant Drug Mass, a Randomized Controlled Trial
The investigators compare 2 different drug regimens using 2 different volumes of lidocaine with the same drug content (i.e. different concentrations) as regards efficacy of post operative analgesia following mastectomy surgery
- Conditions
- Analgesia
- Being tested
- Erector spine plane block
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector spine plane blockProcedure or surgery
Thoracic ESPB
| Study group | Role | What they receive |
|---|---|---|
| L group | Active comparator | Patients are given 20 ml of 2 % lidocaine for ESPB Receives: Procedure: Erector spine plane block |
| H group | Active comparator | Patients are given 40 ml of 1 % lidocaine for ESPB Receives: Procedure: Erector spine plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effective analgesia
Morphine supplements needed
Measured: First 24 hours
Secondary outcomes (1)
Analgesic efficiency
Visual analog scale; ranging from 0 to 10 where 0 is no pain and 10 is pain in its worst form
Measured: Every 2 hours in the first 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2022
- Study start1 Sep 2022 (estimated)
- Primary completion15 Nov 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
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.
- More trials run by Cairo 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Kareem, Cairo University
- Investigators
- Ahmed Kareem, Study director, Kasr alainy hospital, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05514977
- Sponsor's protocol ID
- LOW VS HIGH VOLUME LIDOCAINE
- Status last verified
- Aug 2022
- First submitted
- 19 May 2022
- Last updated
- 25 Aug 2022
- Results posted
- No
- Data monitoring committee
- 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 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Thoracic Erector Spine Plane Block for Post Mastectomy Pain Control, Effect of Volume With Constant Drug Mass, a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05514977
- Acronym / sponsor ID
- LOW VS HIGH VOLUME LIDOCAINE
- Conditions
- Analgesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 15 Nov 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 25 Aug 2022 (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 investigators compare 2 different drug regimens using 2 different volumes of lidocaine with the same drug content (i.e. different concentrations) as regards efficacy of post operative analgesia following mastectomy surgery
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| L group | Active comparator | Procedure: Erector spine plane blockPatients are given 20 ml of 2 % lidocaine for ESPB |
| H group | Active comparator | Procedure: Erector spine plane blockPatients are given 40 ml of 1 % lidocaine for ESPB |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA 2 \& 3 for elective breast cancer surgery
Key exclusion criteria (5 listed)
- ASA > 3
- BMI > 35 kg/m2
- Contraindications to LA (coagulopathy and local infection)
- Allergy to the drug
- Cardiac, hepatic and renal patients
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 spine plane blockThoracic ESPB | Procedure or surgery | H group, L group |
Primary outcome
Effective analgesia
Time frame: First 24 hours
Morphine supplements needed
1 secondary outcome
Analgesic efficiency
Time frame: Every 2 hours in the first 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2022.
- 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.
Ahmed Kareem study director
Kasr alainy hospital, Cairo 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 spine plane block in people with Analgesia, run by Cairo 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 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: status not confirmed, as of the sponsor's last update on 25 Aug 2022. 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 Ahmed Kareem (202 - 01119966884, Dr.ahmedkar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effective analgesia (time frame: First 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 25 Aug 2022.