Breast Cancer FemalePhase 3pec'sNCT03063073
Efficacy and Safety of Dexmedetomidine Added to Modified Pectoral's Block
A Phase 3 study testing Dexmedetomidine Injection [Precedex] and Bupivacaine Injection [Marcaine] in people with Breast Cancer Female, run by South Egypt Cancer Institute at 1 site in Egypt.
Trial summary
The Pecs block (pectoral nerves block) is an easy and reliable superficial block inspired by the infraclavicular block approach and the intercostal abdominis plane blocks . Many additives were used in combination with local anesthetics in Pecs block to prolong the postoperative analgesia (fentanyl, dexmedetomidine). Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- Dexmedetomidine Injection [Precedex] and Bupivacaine Injection [Marcaine]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Feb 2017to 15 Jun 2017
- Phase
- Phase 3
- 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 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- ASA I - II patients
- weight 50- 100 kg
- age 18-60 years
Who cannot join
- History of bleeding diathesis
- Relevant drug allergy
- Opioid dependence
- Sepsis
- Those with psychiatric illnesses that would interfere with perception and assessment of pain will be excluded from the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Dexmedetomidine Added to Modified Pectoral's Block in Patient Undergoing Breast Cancer Surgery :A Comparative Study
The Pecs block (pectoral nerves block) is an easy and reliable superficial block inspired by the infraclavicular block approach and the intercostal abdominis plane blocks . Many additives were used in combination with local anesthetics in Pecs block to prolong the postoperative analgesia (fentanyl, dexmedetomidine).
Read the detailed description
60 patients scheduled for modified radical mastectomy surgery under general anesthesia. Group I (Bupivacaine group): patients underwent modified radical mastectomy were given preoperative ultrasound guided modified Pecs block with 30 mL of 0.25% bupivacaine divided into 10 ml injected between the pectoralis muscles on the interfascial plane, and 20 ml injected between the Pectoralis minor muscle and the serratus muscle.Group II (Bupivacaine + Dexmedetomidine group) : preoperative ultrasound guided modified Pecs block with 30 mL of 0.25% bupivacaine plus Dexmedetomidine (1 µg/kg) divided into 20 ml injected between the pectoralis muscles on the interfascial plane , and 10 ml injected between the Pectoralis minor muscle and the serratus muscle.
- Conditions
- Breast Cancer Female
- Being tested
- Dexmedetomidine Injection [Precedex], Bupivacaine Injection [Marcaine]
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine Injection [Precedex]Drug
Also called [Precedex]
ultrasound guided modified Pecs block with 30 mL of 0.25% bupivacaine (markyrene R sigma -Tec, Egypt) plus (1 µg/kg) Dexmedetomidine Injection [Precedex]
Bupivacaine Injection [Marcaine]Drug
ultrasound guided modified Pec's block with 30 mL of 0.25% bupivacaine divided into 10 ml injected between the pectoralis muscles and 20 ml between the Pectoralis minor muscle and the serratus muscl
| Study group | Role | What they receive |
|---|---|---|
| Group I (Bupivacaine group) | Placebo comparator | ultrasound guided modified Pec's block with 30 mL of 0.25% bupivacaine divided into 10 ml injected between the pectoralis muscles and 20 ml between the Pectoralis minor muscle and the serratus muscle Receives: Drug: Bupivacaine Injection [Marcaine] |
| Dexmedetomidine Injection [Precedex] | Active comparator | ultrasound guided modified Pecs block with 30 mL of 0.25% bupivacaine plus Dexmedetomidine Injection [Precedex] (1 µg/kg) divided into 20 ml injected between the pectoralis muscles and 10 ml injected between the Pectoralis minor muscle and the serratus muscle. Receives: Drug: Dexmedetomidine Injection [Precedex]; Drug: Bupivacaine Injection [Marcaine] |
What is being measured
The primary outcome is the main question the study is designed to answer.
I.V patient controlled analgesia (PCA) morphine consumption
the total dose of I.V patient controlled analgesia (PCA) morphine consumption in the first 48 hours postoperative
Measured: 48 hours postoperative
Secondary outcomes (1)
pain relief
by visual analogue scale measurement
Measured: 48 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2017
- Study start25 Feb 2017
- Primary completion30 May 2017
- Study completion15 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- South Egypt Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Farghaly Abd El hamid Ahmed, South Egypt Cancer Institute
- Investigators
- sahar m abd elbaqy, professor, Study director, manager
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03063073
- Sponsor's protocol ID
- 224
- Acronym
- pec's
- Status last verified
- Feb 2026
- First submitted
- 8 Feb 2017
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Dexmedetomidine Added to Modified Pectoral's Block in Patient Undergoing Breast Cancer Surgery :A Comparative Study
- ClinicalTrials.gov ID
- NCT03063073
- Acronym / sponsor ID
- pec's / 224
- Conditions
- Breast Cancer Female
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- South Egypt Cancer InstituteUniversity, hospital or other
- Study start
- 25 Feb 2017 (actual)
- Primary completion
- 30 May 2017 (actual)
- Study completion
- 15 Jun 2017 (actual)
- First posted
- 24 Feb 2017 (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 Pecs block (pectoral nerves block) is an easy and reliable superficial block inspired by the infraclavicular block approach and the intercostal abdominis plane blocks . Many additives were used in combination with local anesthetics in Pecs block to prolong the postoperative analgesia (fentanyl, dexmedetomidine).
Detailed description
60 patients scheduled for modified radical mastectomy surgery under general anesthesia. Group I (Bupivacaine group): patients underwent modified radical mastectomy were given preoperative ultrasound guided modified Pecs block with 30 mL of 0.25% bupivacaine divided into 10 ml injected between the pectoralis muscles on the interfascial plane, and 20 ml injected between the Pectoralis minor muscle and the serratus muscle.Group II (Bupivacaine + Dexmedetomidine group) : preoperative ultrasound guided modified Pecs block with 30 mL of 0.25% bupivacaine plus Dexmedetomidine (1 µg/kg) divided into 20 ml injected between the pectoralis muscles on the interfascial plane , and 10 ml injected between the Pectoralis minor muscle and the serratus muscle.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (Bupivacaine group) | Placebo comparator | Drug: Bupivacaine Injection [Marcaine]ultrasound guided modified Pec's block with 30 mL of 0.25% bupivacaine divided into 10 ml injected between the pectoralis muscles and 20 ml between the Pectoralis minor muscle and the serratus muscle |
| Dexmedetomidine Injection [Precedex] | Active comparator | Drug: Dexmedetomidine Injection [Precedex], Drug: Bupivacaine Injection [Marcaine]ultrasound guided modified Pecs block with 30 mL of 0.25% bupivacaine plus Dexmedetomidine Injection [Precedex] (1 µg/kg) divided into 20 ml injected between the pectoralis muscles and 10 ml injected between the Pectoralis minor muscle and the serratus muscle. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- ASA I - II patients
- age 18-60 years
Key exclusion criteria (5 listed)
- History of bleeding diathesis
- Relevant drug allergy
- Opioid dependence
- Sepsis
- Those with psychiatric illnesses that would interfere with perception and assessment of pain will be excluded from the study
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 |
|---|---|---|
| Dexmedetomidine Injection [Precedex]Also: [Precedex]ultrasound guided modified Pecs block with 30 mL of 0.25% bupivacaine (markyrene R sigma -Tec, Egypt) plus (1 µg/kg) Dexmedetomidine Injection [Precedex] | Drug | Dexmedetomidine Injection [Precedex] |
| Bupivacaine Injection [Marcaine]ultrasound guided modified Pec's block with 30 mL of 0.25% bupivacaine divided into 10 ml injected between the pectoralis muscles and 20 ml between the Pectoralis minor muscle and the serratus muscl | Drug | Dexmedetomidine Injection [Precedex], Group I (Bupivacaine group) |
Primary outcome
I.V patient controlled analgesia (PCA) morphine consumption
Time frame: 48 hours postoperative
the total dose of I.V patient controlled analgesia (PCA) morphine consumption in the first 48 hours postoperative
1 secondary outcome
pain relief
Time frame: 48 hour
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 12 Feb 2026.
- Individual participant dataSharing planned: Yes
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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.
sahar m abd elbaqy, professor study director
manager
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexmedetomidine Injection [Precedex] and Bupivacaine Injection [Marcaine] in people with Breast Cancer Female, run by South Egypt Cancer Institute 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 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 12 Feb 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
I.V patient controlled analgesia (PCA) morphine consumption (time frame: 48 hours 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 12 Feb 2026.