Erector Spinae Plane BlockNCT06022614
Effect of Adding Dexmedetomidine As Adjuvant to Bupivacaine in US Guided ESPB for Post MRM Pain Management
A study testing Use Bupivacaine 0.25% Injectable Solution and Bupivacaine 0.25% Injectable Solution plus Dexmedetomidine in people with Erector Spinae Plane Block, run by Abanoub Habib at 1 site in Egypt.
Trial summary
The aim of the study is to assess the effect of adding dexmedetomidine to bupivacaine in US guided erector spinae plane block in modified radical mastectomy surgeries , Using visual analogue score and post-operative narcotics consumption. Read more about this study
- Who is it for?
- Ages 30 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Erector Spinae Plane Block
- What is being tested?
- Use Bupivacaine 0.25% Injectable Solution and Bupivacaine 0.25% Injectable Solution plus Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Aug 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 30 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age:30-65years.
- Physical status: ASA I,II.
- BMI<35.
- Localized breast cancer
Who cannot join
- Age:<30 and >65 years.
- Refusal of procedure or participation in the study by the patient.
- Physical status: ASA III or above.
- History of allergy to the study drug.
- BMI>35.
- Bleeding disorders and coagulopathy.
- Psychiatric illness that may interfere with the study.
- Metastatic breast cancer.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Adding Dexmedetomidine As Adjuvant to Bupivacaine in Ultrasound Guided Erector Spinae Plane Block for Post Modified Radical Mastectomy Pain Management
The aim of the study is to assess the effect of adding dexmedetomidine to bupivacaine in US guided erector spinae plane block in modified radical mastectomy surgeries , Using visual analogue score and post-operative narcotics consumption.
Peripheral nerve blocks are effective adjuvant options for pain management in breast surgeries. The use of Erector spinae plane block (ESPB) has been proven to be very effective in controlling pain and minimizing narcotic consumption after modified radical mastectomy surgeries.
Many adjuvants to local anaesthetics were used to improve the duration and intensity of the peripheral nerve block.
Read the detailed description
Breast cancer is one of the most important medical problems in the female gender, since among every eight women, one will suffer from breast cancer during her lifetime.
Acute post-operative pain is very common after breast surgeries which requires adequate pain management. Different peripheral nerve blocks such as paravertebral block had been used as an analgesic option for breast surgeries.
Erector spinae plane block is a newer interfascial plane block first described in 2016 who used it for treating thoracic neuropathic pain by injecting a local anesthetic deep into the erector spinae muscle at the level of T5. Moreover, ESPB is a reasonable option, with clearly identifiable sonographic landmarks and LA needle insertion and injection locations.
Later studies have shown that ESPB can provide effective analgesia in breast surgeries.
ESPB is achieved by injecting the local anesthetics locally deep to erector spinae muscle surface, as a part of multimodal analgesia. Given that erector spinae muscles anatomically situate along the thoracolumbar spine, ESPB promotes an extensive craniocaudal spread.
Ultrasound is a non-invasive visualization technology that helps in capturing the anatomical structure of target tissues, it can help to guide the direction and depth of anesthesia puncture needles, thus reducing the risk of complications .
Adjuvants to local anesthetics, such as opioids, alpha 2 agonists, magnesium and dexamethasone may improve the duration and intensity of peripheral nerve blocks effect.
- Conditions
- Erector Spinae Plane Block
- Being tested
- Use Bupivacaine 0.25% Injectable Solution, Bupivacaine 0.25% Injectable Solution plus Dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use Bupivacaine 0.25% Injectable SolutionDrug
Group A Patients receiving 20 ml Bupivacaine 0.25% added to 1 ml normal saline.
Bupivacaine 0.25% Injectable Solution plus DexmedetomidineDrug
Group B Patients receiving 20 ml Bupivacaine 0.25% added to 1 ml dexmedetomidine
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving Block with Bupivacaine only | Active comparator | consists of patients receiving erector spinae plane block with Bupivacaine only Receives: Drug: Use Bupivacaine 0.25% Injectable Solution |
| Patients receiving Block using Bupivacaine with Dexmedetomidine | Active comparator | consists of patients receiving erector spinae plane block using bupivacaine with Dexmedetomidine Receives: Drug: Bupivacaine 0.25% Injectable Solution plus Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome will be the first time to request rescue analgesia.
The investigators assess first time to request rescue analgesia according to A) pain score from 0 to 10 while 0 means no pain (best) and 10 means sever pain (worst).
Measured: From the end of the surgery till 24 hours
The primary outcome will be the first time to request rescue analgesia
- patient hemodynamics ex. Heart rate if patient is tachypneic (HR more than 100 beat/min) which is means that the patient is in pain.
Measured: From the end of the surgery till 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2023
- Study start15 Aug 2023
- Primary completion1 Jun 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Erector Spinae Plane BlockStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abanoub Habib
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Abanoub Habib, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06022614
- Sponsor's protocol ID
- erector spinae plane block
- Status last verified
- Oct 2024
- First submitted
- 4 Aug 2023
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Feltaoos AM, Abdelhamed HS, Kamal KY, Elagamy AE, Abdulmageed AM. Effect of adding dexmedetomidine as an adjuvant to bupivacaine in ultrasound-guided erector spinae plane block for postoperative pain management following modified radical mastectomy: a randomized controlled trial. BMC Surg. 2026 Mar 4;26(1):251. doi: 10.1186/s12893-026-03557-0.
PubMed 41781939
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Adding Dexmedetomidine As Adjuvant to Bupivacaine in Ultrasound Guided Erector Spinae Plane Block for Post Modified Radical Mastectomy Pain Management
- ClinicalTrials.gov ID
- NCT06022614
- Acronym / sponsor ID
- erector spinae plane block
- Conditions
- Erector Spinae Plane Block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Abanoub HabibUniversity, hospital or other
- Study start
- 15 Aug 2023 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 5 Sep 2023 (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 aim of the study is to assess the effect of adding dexmedetomidine to bupivacaine in US guided erector spinae plane block in modified radical mastectomy surgeries , Using visual analogue score and post-operative narcotics consumption.
Peripheral nerve blocks are effective adjuvant options for pain management in breast surgeries. The use of Erector spinae plane block (ESPB) has been proven to be very effective in controlling pain and minimizing narcotic consumption after modified radical mastectomy surgeries.
Many adjuvants to local anaesthetics were used to improve the duration and intensity of the peripheral nerve block.
Detailed description
Breast cancer is one of the most important medical problems in the female gender, since among every eight women, one will suffer from breast cancer during her lifetime.
Acute post-operative pain is very common after breast surgeries which requires adequate pain management. Different peripheral nerve blocks such as paravertebral block had been used as an analgesic option for breast surgeries.
Erector spinae plane block is a newer interfascial plane block first described in 2016 who used it for treating thoracic neuropathic pain by injecting a local anesthetic deep into the erector spinae muscle at the level of T5. Moreover, ESPB is a reasonable option, with clearly identifiable sonographic landmarks and LA needle insertion and injection locations.
Later studies have shown that ESPB can provide effective analgesia in breast surgeries.
ESPB is achieved by injecting the local anesthetics locally deep to erector spinae muscle surface, as a part of multimodal analgesia. Given that erector spinae muscles anatomically situate along the thoracolumbar spine, ESPB promotes an extensive craniocaudal spread.
Ultrasound is a non-invasive visualization technology that helps in capturing the anatomical structure of target tissues, it can help to guide the direction and depth of anesthesia puncture needles, thus reducing the risk of complications .
Adjuvants to local anesthetics, such as opioids, alpha 2 agonists, magnesium and dexamethasone may improve the duration and intensity of peripheral nerve blocks effect.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients receiving Block with Bupivacaine only | Active comparator | Drug: Use Bupivacaine 0.25% Injectable Solutionconsists of patients receiving erector spinae plane block with Bupivacaine only |
| Patients receiving Block using Bupivacaine with Dexmedetomidine | Active comparator | Drug: Bupivacaine 0.25% Injectable Solution plus Dexmedetomidineconsists of patients receiving erector spinae plane block using bupivacaine with Dexmedetomidine |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age:30-65years.
- Physical status: ASA I,II.
- BMI<35.
- Localized breast cancer
Key exclusion criteria (8 listed)
- Age:<30 and >65 years.
- Refusal of procedure or participation in the study by the patient.
- Physical status: ASA III or above.
- History of allergy to the study drug.
- BMI>35.
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 |
|---|---|---|
| Use Bupivacaine 0.25% Injectable SolutionGroup A Patients receiving 20 ml Bupivacaine 0.25% added to 1 ml normal saline. | Drug | Patients receiving Block with Bupivacaine only |
| Bupivacaine 0.25% Injectable Solution plus DexmedetomidineGroup B Patients receiving 20 ml Bupivacaine 0.25% added to 1 ml dexmedetomidine | Drug | Patients receiving Block using Bupivacaine with Dexmedetomidine |
Primary outcome
The primary outcome will be the first time to request rescue analgesia.
Time frame: From the end of the surgery till 24 hours
The investigators assess first time to request rescue analgesia according to A) pain score from 0 to 10 while 0 means no pain (best) and 10 means sever pain (worst).
The primary outcome will be the first time to request rescue analgesia
Time frame: From the end of the surgery till 24 hours
B) patient hemodynamics ex. Heart rate if patient is tachypneic (HR more than 100 beat/min) which is means that the patient is in pain.
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 2 Oct 2024.
- Derived from this study: PubMed 41781939Feltaoos AM, Abdelhamed HS, Kamal KY, Elagamy AE, Abdulmageed AM. Effect of adding dexmedetomidine as an adjuvant to bupivacaine in ultrasound-guided erector spinae plane block for postoperative pain management following modified radical mastectomy: a randomized controlled trial. BMC Surg. 2026 Mar 4;26(1):251. doi: 10.1186/s12893-026-03557-0.
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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 Use Bupivacaine 0.25% Injectable Solution and Bupivacaine 0.25% Injectable Solution plus Dexmedetomidine in people with Erector Spinae Plane Block, run by Abanoub Habib 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 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 2 Oct 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?
The primary outcome will be the first time to request rescue analgesia. (time frame: From the end of the surgery till 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06022614, which also lists 1 linked publication.
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 2 Oct 2024.