Serratus Anterior Plane BlockNCT06737458
Serratus Anterior Plane Block Versus Erector Spinae Plane Block With Dexmedetomidine Added to Bupivacaine for Ultrasound-Guided Pain Management After Mastectomy
A study testing Bupivacaine + Dexmedetomidine in people with Serratus Anterior Plane Block and Erector Spinae Plane Block, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
This study aimed to compare the serratus plane block versus the erector spinae plane block with dexmedetomidine added to bupivacaine for acute pain management after breast surgeries. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Serratus Anterior Plane Block, Erector Spinae Plane Block, Dexmedetomidine
- What is being tested?
- Bupivacaine + Dexmedetomidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2023to 1 Jul 2024
- 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 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged >20 years.
- Patient's approval.
- American Society of Anesthesiologists (ASA) physical status I-II.
- Patients underwent breast surgeries.
Who cannot join
- Known allergy to local anesthetics, opioids, or dexmedetomidine medications.
- Advanced heart block, ventricular dysfunction.
- Skin infection at the site of injection.
- Pre-existing chronic pain.
- Coagulopathies, significant liver or renal insufficiency.
Trial locations and contacts
1 site in 1 country.
About this study
This study aimed to compare the serratus plane block versus the erector spinae plane block with dexmedetomidine added to bupivacaine for acute pain management after breast surgeries.
Read the detailed description
Approximately 40-60% of breast surgery patients endure severe acute postoperative pain, with over 10% of patients experiencing severe pain for six to twelve months (post-mastectomy pain syndrome).
Dexmedetomidine has analgesic properties, which could be related to the stimulation of α2 adrenoceptors, inhibition of nerve conduction through C and Aδ fibers, and the local release of encephalin.
Serratus plane block (SPB) is an effective approach for breast surgery analgesia due to its simplicity of delivery, minimal risk of adverse effects, and ability to provide significant pain relief.
The erector spinae plane block (ESPB) is one of the emerging regional techniques for managing postoperative pain. ESPB can be given unilaterally during modified radical mastectomy.
- Conditions
- Serratus Anterior Plane Block, Erector Spinae Plane Block, Dexmedetomidine, Bupivacaine, Ultrasound, Pain Management
- Being tested
- Bupivacaine + Dexmedetomidine
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine + DexmedetomidineDrug
Also called Serratus anterior plane block
Patients received serratus anterior plane block on the operated side with bupivacaine 0.25% plus 0.5 µg/kg dexmedetomidine in 30 ml.
Bupivacaine + DexmedetomidineDrug
Also called Erector spinae plane block
Patients received erector spinae plane block at T5 on the operated side and will receive bupivacaine 0.25% plus 0.5 µg/kg dexmedetomidine in 30 ml.
| Study group | Role | What they receive |
|---|---|---|
| Serratus anterior plane block group | Active comparator | Patients received serratus anterior plane block on the operated side with bupivacaine 0.25% plus 0.5 µg/kg dexmedetomidine in 30 ml. Receives: Drug: Bupivacaine + Dexmedetomidine |
| Erector spinae plane block group | Experimental | Patients received erector spinae plane block at T5 on the operated side and will receive bupivacaine 0.25% plus 0.5 µg/kg dexmedetomidine in 30 ml. Receives: Drug: Bupivacaine + Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total dose of pethidine consumption
Patients get 1 g paracetamol IV like clockwork. Salvage absence of pain as bolus IV pethidine at 0.5 mg/kg was managed if NRS > 3
Measured: 24 hours postoperatively
Secondary outcomes (5)
Intraoperative fentanyl consumption
In case the cruel blood vessel weight (Outline) or heart rate (HR) went over 20% of pattern values, additional bolus dosages of 0.5 µg/kg IV fentanyl were given.
Measured: Intraoperatively
Heart rate
Heart rate was measured preoperatively and intraoperatively every 15 minutes until the end of the surgery.
Measured: Every 15 minutes until the end of the surgery (Up to 2 hours)
Mean arterial pressure
Mean arterial pressure was measured preoperatively and intraoperatively every 15 minutes until the end of the surgery.
Measured: Every 15 minutes until the end of the surgery (Up to 2 hours)
Degree of pain
Each patient was instructed about postoperative pain assessment with the numeric rating scale (NRS) score. NRS (0 represents "no pain" while 10 represents "the worst pain imaginable"). NRS was assessed at post anesthesia care unit, 1, 2, 6, 12, 18, and 24 hours postoperatively
Measured: 24 hours postoperatively
Incidence of complications
Incidence of complications such as hypotension, bradycardia, and postoperative nausea and vomiting (PONV) were recorded.
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start1 Jul 2023
- Primary completion1 Jul 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Serratus Anterior Plane BlockStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hend Saad Rizk Farhat, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06737458
- Sponsor's protocol ID
- KFSIRB200-438
- Status last verified
- Dec 2024
- First submitted
- 12 Dec 2024
- Last updated
- 17 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serratus Anterior Plane Block Versus Erector Spinae Plane Block With Dexmedetomidine Added to Bupivacaine for Ultrasound-Guided Pain Management After Mastectomy
- ClinicalTrials.gov ID
- NCT06737458
- Acronym / sponsor ID
- KFSIRB200-438
- Conditions
- Serratus Anterior Plane Block, Erector Spinae Plane Block, Dexmedetomidine, Bupivacaine, Ultrasound, Pain Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 17 Dec 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.
This study aimed to compare the serratus plane block versus the erector spinae plane block with dexmedetomidine added to bupivacaine for acute pain management after breast surgeries.
Detailed description
Approximately 40-60% of breast surgery patients endure severe acute postoperative pain, with over 10% of patients experiencing severe pain for six to twelve months (post-mastectomy pain syndrome).
Dexmedetomidine has analgesic properties, which could be related to the stimulation of α2 adrenoceptors, inhibition of nerve conduction through C and Aδ fibers, and the local release of encephalin.
Serratus plane block (SPB) is an effective approach for breast surgery analgesia due to its simplicity of delivery, minimal risk of adverse effects, and ability to provide significant pain relief.
The erector spinae plane block (ESPB) is one of the emerging regional techniques for managing postoperative pain. ESPB can be given unilaterally during modified radical mastectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Serratus anterior plane block group | Active comparator | Drug: Bupivacaine + DexmedetomidinePatients received serratus anterior plane block on the operated side with bupivacaine 0.25% plus 0.5 µg/kg dexmedetomidine in 30 ml. |
| Erector spinae plane block group | Experimental | Drug: Bupivacaine + DexmedetomidinePatients received erector spinae plane block at T5 on the operated side and will receive bupivacaine 0.25% plus 0.5 µg/kg dexmedetomidine in 30 ml. |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women aged >20 years.
- Patient's approval.
- American Society of Anesthesiologists (ASA) physical status I-II.
- Patients underwent breast surgeries.
Key exclusion criteria (5 listed)
- Known allergy to local anesthetics, opioids, or dexmedetomidine medications.
- Advanced heart block, ventricular dysfunction.
- Skin infection at the site of injection.
- Pre-existing chronic pain.
- Coagulopathies, significant liver or renal insufficiency.
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 |
|---|---|---|
| Bupivacaine + DexmedetomidineAlso: Serratus anterior plane blockPatients received serratus anterior plane block on the operated side with bupivacaine 0.25% plus 0.5 µg/kg dexmedetomidine in 30 ml. | Drug | Serratus anterior plane block group |
| Bupivacaine + DexmedetomidineAlso: Erector spinae plane blockPatients received erector spinae plane block at T5 on the operated side and will receive bupivacaine 0.25% plus 0.5 µg/kg dexmedetomidine in 30 ml. | Drug | Erector spinae plane block group |
Primary outcome
Total dose of pethidine consumption
Time frame: 24 hours postoperatively
Patients get 1 g paracetamol IV like clockwork. Salvage absence of pain as bolus IV pethidine at 0.5 mg/kg was managed if NRS > 3
5 secondary outcomes
Intraoperative fentanyl consumption
Time frame: Intraoperatively
Heart rate
Time frame: Every 15 minutes until the end of the surgery (Up to 2 hours)
Mean arterial pressure
Time frame: Every 15 minutes until the end of the surgery (Up to 2 hours)
Degree of pain
Time frame: 24 hours postoperatively
Incidence of complications
Time frame: 24 hours postoperatively
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 17 Dec 2024.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bupivacaine + Dexmedetomidine in people with Serratus Anterior Plane Block and Erector Spinae Plane Block, run by Kafrelsheikh 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 4 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 17 Dec 2024. 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?
Total dose of pethidine consumption (time frame: 24 hours postoperatively). 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 17 Dec 2024.