BreastcancerNCT06502067
Efficacy of Serratus Posterior Intercostal Plane Block for Analgesia and Inflammatory Marker in Breast Surgery
A study testing Analgesia mangement group A,B in people with Breastcancer and Perioperative Pain, run by Ain Shams University.
Trial summary
To study the efficiacy of serratus posterior superior block in controlling perioperative breast cancer surgery pain and its effect on inflamatory markers. Read more about this study
- Who is it for?
- Ages 21 to 60 years, women only
- Conditions the study is for
- Breastcancer, Perioperative Pain, Inflammation
- What is being tested?
- Analgesia mangement group A,B
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 25 Jul 2024to 1 Jul 2025
- 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 21 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Adults undergoing unilateral breast surgery under general anesthesia
- Age 21 to 60 years with body mass index (BMI)=18 to 25 kg/m2
- American Society of Anesthesiologists (ASA) grade I-III.
Who cannot join
- Patients with Long-time use of analgesic drugs
- Past history of chest surgery,
- Allergy to local anesthetics,
- Systemic infection,
- Cognitive and language disorders precluding participation,
- Patients with coagulopathy,anticoagulant users
Show all 10Show fewer
- hemodynamic unstable patients
- Patients with neurology, spinal, psychiatry diseases
- infection at block site
- patients refused to participate in the study .
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Efficacy of Serratus Posterior Superior Intercostal Plane Block (SPSIPB) on Perioperative Analgesia and Inflamatory Markers in Breast Surgery
To study the efficiacy of serratus posterior superior block in controlling perioperative breast cancer surgery pain and its effect on inflamatory markers.
Read the detailed description
Back ground The presence of pain during the initial course of treatment in women with early-stage breast cancer was associated with significantly higher levels of c-reactive protein(CRP) ,interleukin-7(IL-7)and interleukin-13(IL-13) There is evidence of effectiveness of regional block in controlling inflamatory markers Serratus posterior superior intercostal plane block (SPSIPB) is a novel Regional technique that provides analgesia in the hemithorax, shoulder, and back of the neck which proved its efficacy in controlling pain after Video assisted thoracoscopic surgery there are little epidemiological data on (SPSIPB)usage in masectomy and lumpectomy procedures and its effect on inflamatory markers
Methodology:
- Type of the Study: Randomized prospective comparative controlled double-blinded study
- Study Setting: Ain Shams University Hospitals
- Study Period: One year after approval of the protocol.
- Place :Ain shams university hospitals
- Study Population: Adult patients who will undergo breast cancer surgey.
- Conditions
- Breastcancer, Perioperative Pain, Inflammation
- Being tested
- Analgesia mangement group A,B
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analgesia mangement group A,BDrug
1gm of paracetamol, 30mg of ketorolac and 1mg Granitryl will be given twenty minutes before the end of the operation .
| Study group | Role | What they receive |
|---|---|---|
| will receive serratus posterior superior block using bupivacaine | Active comparator | between the SPSM and the 3rd rib after using a test dose of 1- 2 mL saline and Following hydro-dissection,30ml 0.25%bupivacaine will be injected. Receives: Drug: Analgesia mangement group A,B |
| Arm B: (control group) patients will only receive general anesthesia without block. | Other | Narcotic postoperative Receives: Drug: Analgesia mangement group A,B |
What is being measured
The primary outcome is the main question the study is designed to answer.
is to calculate total perioperative analgesia consumption throughout (24hours).
Measured: 24 hour postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2024
- Study start25 Jul 2024 (estimated)
- Primary completion2 Jun 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BreastcancerStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06502067
- Sponsor's protocol ID
- MD94/2024
- Status last verified
- Jul 2024
- First submitted
- 6 Jul 2024
- Last updated
- 23 Jul 2024
- 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 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Serratus Posterior Superior Intercostal Plane Block (SPSIPB) on Perioperative Analgesia and Inflamatory Markers in Breast Surgery
- ClinicalTrials.gov ID
- NCT06502067
- Acronym / sponsor ID
- MD94/2024
- Conditions
- Breastcancer, Perioperative Pain, Inflammation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 25 Jul 2024 (estimated)
- Primary completion
- 2 Jun 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 15 Jul 2024 (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.
To study the efficiacy of serratus posterior superior block in controlling perioperative breast cancer surgery pain and its effect on inflamatory markers.
Detailed description
Back ground The presence of pain during the initial course of treatment in women with early-stage breast cancer was associated with significantly higher levels of c-reactive protein(CRP) ,interleukin-7(IL-7)and interleukin-13(IL-13) There is evidence of effectiveness of regional block in controlling inflamatory markers Serratus posterior superior intercostal plane block (SPSIPB) is a novel Regional technique that provides analgesia in the hemithorax, shoulder, and back of the neck which proved its efficacy in controlling pain after Video assisted thoracoscopic surgery there are little epidemiological data on (SPSIPB)usage in masectomy and lumpectomy procedures and its effect on inflamatory markers
Methodology:
- Type of the Study: Randomized prospective comparative controlled double-blinded study
- Study Setting: Ain Shams University Hospitals
- Study Period: One year after approval of the protocol.
- Place :Ain shams university hospitals
- Study Population: Adult patients who will undergo breast cancer surgey.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| will receive serratus posterior superior block using bupivacaine | Active comparator | Drug: Analgesia mangement group A,Bbetween the SPSM and the 3rd rib after using a test dose of 1- 2 mL saline and Following hydro-dissection,30ml 0.25%bupivacaine will be injected. |
| Arm B: (control group) patients will only receive general anesthesia without block. | Other | Drug: Analgesia mangement group A,BNarcotic postoperative |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adults undergoing unilateral breast surgery under general anesthesia
- Age 21 to 60 years with body mass index (BMI)=18 to 25 kg/m2
- American Society of Anesthesiologists (ASA) grade I-III.
Key exclusion criteria (10 listed)
- Patients with Long-time use of analgesic drugs
- Past history of chest surgery,
- Allergy to local anesthetics,
- Systemic infection,
- Cognitive and language disorders precluding participation,
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 |
|---|---|---|
| Analgesia mangement group A,B1gm of paracetamol, 30mg of ketorolac and 1mg Granitryl will be given twenty minutes before the end of the operation . | Drug | Arm B: (control group) patients will only receive general anesthesia without block., will receive serratus posterior superior block using bupivacaine |
Primary outcome
is to calculate total perioperative analgesia consumption throughout (24hours).
Time frame: 24 hour postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Analgesia mangement group A,B in people with Breastcancer and Perioperative Pain, run by Ain Shams University.
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 10 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 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Dalia Mostafa Ghazy, Master degree (01060192709, daliaibrahimghazy@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
is to calculate total perioperative analgesia consumption throughout (24hours). (time frame: 24 hour postoperative). 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 23 Jul 2024.