AnalgesiaNCT07683416
Regional Block for Post-mastectomy Analgesia
A study testing Serratus-intercostal plane block, Erector spinae plane block and Dexmedetomidine Injection in people with Analgesia, run by Zagazig University at 1 site in Egypt.
Trial summary
A large number of patients undergoing major surgical procedures for the management of breast cancer complain of acute and chronic postoperative pain. Morphine administration for acute pain after mastectomy surgery has many side effects. Read more about this study
- Who is it for?
- Ages 21 to 64 years, women only
- Conditions the study is for
- Analgesia
- What is being tested?
- Serratus-intercostal plane block, Erector spinae plane block and Dexmedetomidine Injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2026to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 64 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Unilateral mastectomy operations.
- Body mass index less than 35 kg per square meter.
- American Society of Anesthesiologists physical status grade I-II.
Who cannot join
- Patient refusal.
- History of chronic pain therapy.
- Infection at the injection site.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dexmedetomidine as an Adjuvant to Bupivacaine for Serratus-Intercostal Versus Erector-Spinae Plane Block to Relieve Post-Mastectomy Pain
A large number of patients undergoing major surgical procedures for the management of breast cancer complain of acute and chronic postoperative pain. Morphine administration for acute pain after mastectomy surgery has many side effects. Regional block techniques, such as paravertebral block and thoracic epidural anaesthesia, have possible complications and technical difficulties. So, we will discuss adding dexmedetomidine as an adjuvant to bupivacaine for serratus-intercostal versus erector-spinae plane block to relieve post-mastectomy pain.
Read the detailed description
Current pain management encompasses regional anaesthetic techniques and systemic administration of analgesia with a synergetic effect on pain. Regional analgesic techniques improve perioperative pain control, reduce opioid consumption and side-effects. We will investigate whether adding dexmedetomidine to bupivacaine for the serratus-intercostal plane block or the erector-spinae plane block during breast surgery could provide better intraoperative and postoperative analgesia, delay the time to first analgesic request, and reduce intraoperative and postoperative analgesic consumption.
- Conditions
- Analgesia
- Being tested
- Serratus-intercostal plane block, Erector spinae plane block, Dexmedetomidine Injection
- Keywords
- Analgesia, Mastectomy, Nerve Block, Bupivacaine
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serratus-intercostal plane blockProcedure or surgery
The patients will receive an ultrasound-guided serratus-intercostal plane block after induction of anaesthesia, using 0.25% bupivacaine and 1 μg/kg dexmedetomidine.
Erector spinae plane blockProcedure or surgery
The patients will receive an ultrasound-guided erector spinae plane block after induction of anaesthesia, using 0.25% bupivacaine and 1 μg/kg dexmedetomidine.
Dexmedetomidine InjectionDrug
Also called Precedex
The local anaesthetic mixture will include 0.25% bupivacaine plus 1 μg/kg dexmedetomidine.
| Study group | Role | What they receive |
|---|---|---|
| Serratus-intercostal plane block | Active comparator | The patients will receive an ultrasound-guided serratus-intercostal plane block after induction of general anaesthesia and before surgical incision. Receives: Procedure: Serratus-intercostal plane block; Drug: Dexmedetomidine Injection |
| Erector spinae plane block | Active comparator | The patients will receive an ultrasound-guided erector spinae plane block after induction of general anaesthesia and before surgical incision. Receives: Procedure: Erector spinae plane block; Drug: Dexmedetomidine Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The total opioid consumption.
The total opioid consumption (morphine) in the first 24 hours postoperative.
Measured: The first 24 hours postoperative.
Secondary outcomes (3)
Time of the first rescue analgesia
Time of the first rescue analgesia needed by the patient when visual analogue pain score ≥4.
Measured: The first 24 hours postoperative.
The static and dynamic visual analogue scale
The static and dynamic visual analogue scale pain score with score 10 indicates the maximum pain and score 0 indicates no pain.
Measured: The first 24 hours postoperative.
Number of participants with procedure-related adverse events
Associated side effects related to the procedure as vascular or nerve injury, pneumothorax, and local anaesthetic systemic toxicity.
Measured: The first 24 hours postoperative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start1 Jun 2026
- Primary completionJan 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- More trials run by Zagazig 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Nahla Mohamed Amin, MD, Study director, Department of Anesthesia, Intensive Care & Pain Management, Zagazig UniversitySamia Mohamed Masoud, MD, Study chair, Department of Anesthesia, Intensive Care & Pain Management, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07683416
- Sponsor's protocol ID
- Breast surgery analgesia
- Status last verified
- Jun 2026
- First submitted
- 27 Jun 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nyima T, Palta S, Saroa R, Kaushik R, Gombar S. Ultrasound-guided erector spinae plane block compared to serratus anterior muscle block for postoperative analgesia in modified radical mastectomy surgeries: A randomized control trial. Saudi J Anaesth. 2023 Jul-Sep;17(3):311-317. doi: 10.4103/sja.sja_716_22. Epub 2023 Jun 22.
PubMed 37601524Vanni G, Caiazza G, Materazzo M, Storti G, Pellicciaro M, Buonomo C, Natoli S, Fabbi E, Dauri M. Erector Spinae Plane Block Versus Serratus Plane Block in Breast Conserving Surgery: Alpha Randomized Controlled Trial. Anticancer Res. 2021 Nov;41(11):5667-5676. doi: 10.21873/anticanres.15383.
PubMed 34732440Villa G, Mandarano R, Scire-Calabrisotto C, Rizzelli V, Del Duca M, Montin DP, Paparella L, De Gaudio AR, Romagnoli S. Chronic pain after breast surgery: incidence, associated factors, and impact on quality of life, an observational prospective study. Perioper Med (Lond). 2021 Feb 24;10(1):6. doi: 10.1186/s13741-021-00176-6.
PubMed 33622393
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine as an Adjuvant to Bupivacaine for Serratus-Intercostal Versus Erector-Spinae Plane Block to Relieve Post-Mastectomy Pain
- ClinicalTrials.gov ID
- NCT07683416
- Acronym / sponsor ID
- Breast surgery analgesia
- Conditions
- Analgesia
- Keywords
- Analgesia, Mastectomy, Nerve Block, Bupivacaine
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 6 Jul 2026 (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.
A large number of patients undergoing major surgical procedures for the management of breast cancer complain of acute and chronic postoperative pain. Morphine administration for acute pain after mastectomy surgery has many side effects. Regional block techniques, such as paravertebral block and thoracic epidural anaesthesia, have possible complications and technical difficulties. So, we will discuss adding dexmedetomidine as an adjuvant to bupivacaine for serratus-intercostal versus erector-spinae plane block to relieve post-mastectomy pain.
Detailed description
Current pain management encompasses regional anaesthetic techniques and systemic administration of analgesia with a synergetic effect on pain. Regional analgesic techniques improve perioperative pain control, reduce opioid consumption and side-effects. We will investigate whether adding dexmedetomidine to bupivacaine for the serratus-intercostal plane block or the erector-spinae plane block during breast surgery could provide better intraoperative and postoperative analgesia, delay the time to first analgesic request, and reduce intraoperative and postoperative analgesic consumption.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Serratus-intercostal plane block | Active comparator | Procedure: Serratus-intercostal plane block, Drug: Dexmedetomidine InjectionThe patients will receive an ultrasound-guided serratus-intercostal plane block after induction of general anaesthesia and before surgical incision. |
| Erector spinae plane block | Active comparator | Procedure: Erector spinae plane block, Drug: Dexmedetomidine InjectionThe patients will receive an ultrasound-guided erector spinae plane block after induction of general anaesthesia and before surgical incision. |
Who may qualify
- Ages
- 21 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Unilateral mastectomy operations.
- Body mass index less than 35 kg per square meter.
- American Society of Anesthesiologists physical status grade I-II.
Key exclusion criteria (3 listed)
- Patient refusal.
- History of chronic pain therapy.
- Infection at the injection site.
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-intercostal plane blockThe patients will receive an ultrasound-guided serratus-intercostal plane block after induction of anaesthesia, using 0.25% bupivacaine and 1 μg/kg dexmedetomidine. | Procedure or surgery | Serratus-intercostal plane block |
| Erector spinae plane blockThe patients will receive an ultrasound-guided erector spinae plane block after induction of anaesthesia, using 0.25% bupivacaine and 1 μg/kg dexmedetomidine. | Procedure or surgery | Erector spinae plane block |
| Dexmedetomidine InjectionAlso: PrecedexThe local anaesthetic mixture will include 0.25% bupivacaine plus 1 μg/kg dexmedetomidine. | Drug | Erector spinae plane block, Serratus-intercostal plane block |
Primary outcome
The total opioid consumption.
Time frame: The first 24 hours postoperative.
The total opioid consumption (morphine) in the first 24 hours postoperative.
3 secondary outcomes
Time of the first rescue analgesia
Time frame: The first 24 hours postoperative.
The static and dynamic visual analogue scale
Time frame: The first 24 hours postoperative.
Number of participants with procedure-related adverse events
Time frame: The first 24 hours postoperative.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Background: PubMed 37601524Nyima T, Palta S, Saroa R, Kaushik R, Gombar S. Ultrasound-guided erector spinae plane block compared to serratus anterior muscle block for postoperative analgesia in modified radical mastectomy surgeries: A randomized control trial. Saudi J Anaesth. 2023 Jul-Sep;17(3):311-317. doi: 10.4103/sja.sja_716_22. Epub 2023 Jun 22.
- Background: PubMed 34732440Vanni G, Caiazza G, Materazzo M, Storti G, Pellicciaro M, Buonomo C, Natoli S, Fabbi E, Dauri M. Erector Spinae Plane Block Versus Serratus Plane Block in Breast Conserving Surgery: Alpha Randomized Controlled Trial. Anticancer Res. 2021 Nov;41(11):5667-5676. doi: 10.21873/anticanres.15383.
- Background: PubMed 33622393Villa G, Mandarano R, Scire-Calabrisotto C, Rizzelli V, Del Duca M, Montin DP, Paparella L, De Gaudio AR, Romagnoli S. Chronic pain after breast surgery: incidence, associated factors, and impact on quality of life, an observational prospective study. Perioper Med (Lond). 2021 Feb 24;10(1):6. doi: 10.1186/s13741-021-00176-6.
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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.
Nahla Mohamed Amin, MD study director
Department of Anesthesia, Intensive Care & Pain Management, Zagazig University
Samia Mohamed Masoud, MD study chair
Department of Anesthesia, Intensive Care & Pain Management, Zagazig 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 Serratus-intercostal plane block, Erector spinae plane block and Dexmedetomidine Injection in people with Analgesia, run by Zagazig 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 3 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 24 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
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 total opioid consumption. (time frame: The first 24 hours postoperative.). 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 NCT07683416, which also lists 3 linked publications.
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 24 Aug 2026.