Post Operative PainNCT05717114
Dexmetomedine as an Adjuvant to Bupivacaine in Ultrasound Guided PECS Block
A study testing Pecs block in people with Post Operative Pain, run by Menoufia University at 1 site in Egypt.
Trial summary
Regional anesthesia is an essential component of anesthesia and analgesia. It has many advantages, it decreases pain post operatively, improves patient outcome and allow early recovery and ambulation Post-operative pain following breast surgery results from injured muscles and nerves, management of acute post… Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- Pecs block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Feb 2023to 1 Jan 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 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- adult patients
- aged 18-60years old
- ASA class 1 to 3
- scheduled for elective modified radical mastectomy
Who cannot join
- patients refusal,
- coagulopathies
- concurrent anticoagulant therapy
- allergy to local anaesthetics
- infection at puncture site
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Different Doses of Dexmetomedine as an Adjuvant to Bupivacaine in Ultrasound Guided PECS Block in Patients Undergoing Modified Radical Mastectomy
Regional anesthesia is an essential component of anesthesia and analgesia. It has many advantages, it decreases pain post operatively, improves patient outcome and allow early recovery and ambulation Post-operative pain following breast surgery results from injured muscles and nerves, management of acute post operative pain is a consistent factor for better outcome and patient satisfaction
Read the detailed description
All patients will be monitored by standard intraoperative monitoring that includes continuous electrocardiography (ECG), capnography, pulse oximetry, and non invasive blood pressure.
Induction of general anesthesia will be done by propofol 1.5-2 mg/kg and fentanyl 3µg/kg.
Tracheal intubation will be facilitated by administration of rocuronium 0.8 mg/kg. Anesthesia will be maintained with isoflurane 1MAC (Pecs block):the block will be performed with the patients in the supine position.The infraclavicular and axillary regions will be cleaned with antiseptic solution. the in plane technique will be used from proximal and medial to distal and lateral in an oblique manner at dermatome level T2 and T3.The puncture site was infiltrated with 2%lidocaine and once the structures is identified with Ultrasound
- Conditions
- Post Operative Pain
- Being tested
- Pecs block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pecs blockProcedure or surgery
(Pecs block):the block will be performed with the patients in the supine position.The infraclavicular and axillary regions will be cleaned with antiseptic solution. the inplane technique will be used from proximal and medial to distal and lateral in an oblique manner at dermatome level T2and T3.The puncture site was infiltrated with 2%lidocaine and once the structures is identified with ultrasound.
| Study group | Role | What they receive |
|---|---|---|
| Group I | Placebo comparator | received plan bupivacaine1ml/Kg Receives: Procedure: Pecs block |
| Group II | Active comparator | received plain bupivacaine 1ml/Kg plus dexmetomedine0.5 µg/Kg Receives: Procedure: Pecs block |
| GroupIII | Active comparator | received plain bupivacaine 1ml/Kg plus dexmetomedine1µg/Kg Receives: Procedure: Pecs block |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain
Visual analog score for pain where 0 no pain and 10 most severe pain
Measured: 48 hours
Secondary outcomes (1)
Total morphine consumption
Mg
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start5 Feb 2023
- Primary completion25 Dec 2023
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- More trials run by Menoufia 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomized study
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, rabab Mohammad habeeb, Menoufia University
- Investigators
- rabab M habeeb, Principal investigator, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05717114
- Sponsor's protocol ID
- 1/2023,ANET2-1
- Status last verified
- Jan 2024
- First submitted
- 23 Jan 2023
- Last updated
- 31 Jan 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 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Different Doses of Dexmetomedine as an Adjuvant to Bupivacaine in Ultrasound Guided PECS Block in Patients Undergoing Modified Radical Mastectomy
- ClinicalTrials.gov ID
- NCT05717114
- Acronym / sponsor ID
- 1/2023,ANET2-1
- Conditions
- Post Operative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 5 Feb 2023 (actual)
- Primary completion
- 25 Dec 2023 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 8 Feb 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.
Regional anesthesia is an essential component of anesthesia and analgesia. It has many advantages, it decreases pain post operatively, improves patient outcome and allow early recovery and ambulation Post-operative pain following breast surgery results from injured muscles and nerves, management of acute post operative pain is a consistent factor for better outcome and patient satisfaction
Detailed description
All patients will be monitored by standard intraoperative monitoring that includes continuous electrocardiography (ECG), capnography, pulse oximetry, and non invasive blood pressure.
Induction of general anesthesia will be done by propofol 1.5-2 mg/kg and fentanyl 3µg/kg.
Tracheal intubation will be facilitated by administration of rocuronium 0.8 mg/kg. Anesthesia will be maintained with isoflurane 1MAC (Pecs block):the block will be performed with the patients in the supine position.The infraclavicular and axillary regions will be cleaned with antiseptic solution. the in plane technique will be used from proximal and medial to distal and lateral in an oblique manner at dermatome level T2 and T3.The puncture site was infiltrated with 2%lidocaine and once the structures is identified with Ultrasound
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Prospective randomized study
| Arm | Type | Receives |
|---|---|---|
| Group I | Placebo comparator | Procedure: Pecs blockreceived plan bupivacaine1ml/Kg |
| Group II | Active comparator | Procedure: Pecs blockreceived plain bupivacaine 1ml/Kg plus dexmetomedine0.5 µg/Kg |
| GroupIII | Active comparator | Procedure: Pecs blockreceived plain bupivacaine 1ml/Kg plus dexmetomedine1µg/Kg |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- adult patients
- aged 18-60years old
- ASA class 1 to 3
- scheduled for elective modified radical mastectomy
Key exclusion criteria (5 listed)
- patients refusal,
- coagulopathies
- concurrent anticoagulant therapy
- allergy to local anaesthetics
- infection at puncture 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 |
|---|---|---|
| Pecs block(Pecs block):the block will be performed with the patients in the supine position.The infraclavicular and axillary regions will be cleaned with antiseptic solution. the inplane technique will be used from proximal and medial to distal and lateral in an oblique manner at dermatome level T2and T3.The puncture site was infiltrated with 2%lidocaine and once the structures is identified with ultrasound. | Procedure or surgery | Group I, Group II, GroupIII |
Primary outcome
postoperative pain
Time frame: 48 hours
Visual analog score for pain where 0 no pain and 10 most severe pain
1 secondary outcome
Total morphine consumption
Time frame: 48 hours
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 31 Jan 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.
rabab M habeeb principal investigator
Menoufia 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 Pecs block in people with Post Operative Pain, run by Menoufia 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 31 Jan 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. 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.
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?
postoperative pain (time frame: 48 hours). 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 31 Jan 2024.