Pain, PostoperativePhase 2/3NCT04732364
Analgesic Efficacy of Ultrasound Guided Erector Spinae Block for Modified Radical Mastectomy
A Phase 2/3 study testing ultrasound guided erector spinae plan block using bupivacaine for modified radical mastectomy, ultrasound guided erector spinae plan block with bupivacaine and Dexmetonidine for modified radical mastectomy and ultrasound guided erector spinae plan block with bupivacaine and magnesium slphate for modified radical mastectomy in people with Pain, Postoperative, run by South Egypt Cancer Institute at 1 site in Egypt.
Trial summary
To compare the analgesic efficacy of dexmedetomidine and magnesium sulphate as adjuvants to levobupivacaine in erector spinae plane block in modified radical mastectomy surgery for acute and chronic pain management. Read more about this study
- Who is it for?
- Ages 25 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- ultrasound guided erector spinae plan block using bupivacaine for modified radical mastectomy, ultrasound guided erector spinae plan block with bupivacaine and Dexmetonidine for modified radical mastectomy and ultrasound guided erector spinae plan block with bupivacaine and magnesium slphate for modified radical mastectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Apr 2018to 28 Feb 2021
- Phase
- Phase 2/3
- 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 25 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- female patient
- American society of anesthesiologists (ASA) I and II physical status
- age from 25 to 70 years old
- scheduled for either left or right modified radical mastectomy (MRM).
Who cannot join
- infection of the skin at or near site of needle puncture
- coagulopathy
- drug hypersensitivity or allergy to the studied drugs
- central or peripheral neuropathy
- significant organ dysfunction cardiac dysrrhythmias
- obesity (BMI>35kg/m2)
- recently use analgesic drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analgesic Efficacy of Magnesium Sulphate as an Adjuvant to Levo-bupivacine in Ultrasound Guided Erector Spinae Plan Block for Modified Radical Mastectomy
To compare the analgesic efficacy of dexmedetomidine and magnesium sulphate as adjuvants to levobupivacaine in erector spinae plane block in modified radical mastectomy surgery for acute and chronic pain management.
Read the detailed description
3 groups.
Group (C) / (I):20 patient (control group) :
Patients will receive 20 ml 0.25% levobupivacaine into the interfascial plane below erector spinae muscle at level of T5.
Group (D)/ (II) :20 patient (Dexmetonidine group) :
Patient will receive 20ml 0.25% levobupivacaineas above + 1μ/kg dexmedetomidine.
Group (M) / (III) : 20 patient (magnesium slphate group) :
Patient will receive 20ml 0.25% levobupivacaineas above + 0.7 mg/kg MgSo4 . The patient, the anesthesiologist who administered the drugs, and the data collector will be blinded to the study drugs.
- Conditions
- Pain, Postoperative
- Being tested
- ultrasound guided erector spinae plan block using bupivacaine for modified radical mastectomy, ultrasound guided erector spinae plan block with bupivacaine and Dexmetonidine for modified radical mastectomy, ultrasound guided erector spinae plan block with bupivacaine and magnesium slphate for modified radical mastectomy
- Keywords
- Erector Spinae Block, magnesium sulphate, dexmedetomidine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound guided erector spinae plan block using bupivacaine for modified radical mastectomyProcedure or surgery
Ultrasound guided Erector spinae plane (ESP) block will be given with patient in sitting position depending on surgical site (left or right) ESP block will be given using high frequency linear u/s transducer, the probe is placed in longitudinal orientation lateral to thoracic fifth spinous process, then Trapezius muscle, Rhomboidus major muscle, and erector spinae muscle
ultrasound guided erector spinae plan block with bupivacaine and Dexmetonidine for modified radical mastectomyProcedure or surgery
Ultrasound guided Erector spinae plane (ESP) block will be given with patient in sitting position depending on surgical site (left or right) ESP block will be given using high frequency linear u/s transducer, the probe is placed in longitudinal orientation lateral to thoracic fifth spinous process, then Trapezius muscle, Rhomboidus major muscle, and erector spinae muscle
ultrasound guided erector spinae plan block with bupivacaine and magnesium slphate for modified radical mastectomyProcedure or surgery
Ultrasound guided Erector spinae plane (ESP) block will be given with patient in sitting position depending on surgical site (left or right) ESP block will be given using high frequency linear u/s transducer, the probe is placed in longitudinal orientation lateral to thoracic fifth spinous process, then Trapezius muscle, Rhomboidus major muscle, and erector spinae muscle
| Study group | Role | What they receive |
|---|---|---|
| Group (C) (control group): | Placebo comparator | Patient will receive 20 ml 0.25% levobupivacaine into interfascial plane below erector spinae muscle at level of T5. Receives: Procedure: ultrasound guided erector spinae plan block using bupivacaine for modified radical mastectomy |
| Group (D) (Dexmetonidine group): | Active comparator | Patient will receive 20ml 0.25% levobupivacaine + 1μ/kg dexmedetomidine into interfascial plane below erector spinae muscle at level of T5.. Receives: Procedure: ultrasound guided erector spinae plan block with bupivacaine and Dexmetonidine for modified radical mastectomy |
| Group (M) (magnesium slphate group): | Active comparator | Patient will receive 20ml 0.25% levobupivacaine + 0.7 mg/kg MgSo4 into interfascial plane below erector spinae muscle at level of T5.. Receives: Procedure: ultrasound guided erector spinae plan block with bupivacaine and magnesium slphate for modified radical mastectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
analgesia requirement
first request for analgesia and total analgesia requirements
Measured: 24 hours
Secondary outcomes (1)
chronic pain assessment
Assessment of chronic pain at 1-3 and 6 month post-operatively using LANSS pain score. a score of 12 or more is suggestive of neuropathic pain.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2021
- Study start30 Apr 2018
- Primary completion28 Feb 2021 (estimated)
- Study completion28 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South Egypt Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Rafaat Edward Iskander, South Egypt Cancer Institute
- Investigators
- peter R Edward, MSc, Principal investigator, specialist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04732364
- Sponsor's protocol ID
- peter SECI
- Status last verified
- Jan 2021
- First submitted
- 6 Jan 2021
- Last updated
- 1 Feb 2021
- 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 1 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of Magnesium Sulphate as an Adjuvant to Levo-bupivacine in Ultrasound Guided Erector Spinae Plan Block for Modified Radical Mastectomy
- ClinicalTrials.gov ID
- NCT04732364
- Acronym / sponsor ID
- peter SECI
- Conditions
- Pain, Postoperative
- Keywords
- Erector Spinae Block, magnesium sulphate, dexmedetomidine
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- South Egypt Cancer InstituteUniversity, hospital or other
- Study start
- 30 Apr 2018 (actual)
- Primary completion
- 28 Feb 2021 (estimated)
- Study completion
- 28 Feb 2021 (estimated)
- First posted
- 1 Feb 2021 (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.
To compare the analgesic efficacy of dexmedetomidine and magnesium sulphate as adjuvants to levobupivacaine in erector spinae plane block in modified radical mastectomy surgery for acute and chronic pain management.
Detailed description
3 groups.
Group (C) / (I):20 patient (control group) :
Patients will receive 20 ml 0.25% levobupivacaine into the interfascial plane below erector spinae muscle at level of T5.
Group (D)/ (II) :20 patient (Dexmetonidine group) :
Patient will receive 20ml 0.25% levobupivacaineas above + 1μ/kg dexmedetomidine.
Group (M) / (III) : 20 patient (magnesium slphate group) :
Patient will receive 20ml 0.25% levobupivacaineas above + 0.7 mg/kg MgSo4 . The patient, the anesthesiologist who administered the drugs, and the data collector will be blinded to the study drugs.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group (C) (control group): | Placebo comparator | Procedure: ultrasound guided erector spinae plan block using bupivacaine for modified radical mastectomyPatient will receive 20 ml 0.25% levobupivacaine into interfascial plane below erector spinae muscle at level of T5. |
| Group (D) (Dexmetonidine group): | Active comparator | Procedure: ultrasound guided erector spinae plan block with bupivacaine and Dexmetonidine for modified radical mastectomyPatient will receive 20ml 0.25% levobupivacaine + 1μ/kg dexmedetomidine into interfascial plane below erector spinae muscle at level of T5.. |
| Group (M) (magnesium slphate group): | Active comparator | Procedure: ultrasound guided erector spinae plan block with bupivacaine and magnesium slphate for modified radical mastectomyPatient will receive 20ml 0.25% levobupivacaine + 0.7 mg/kg MgSo4 into interfascial plane below erector spinae muscle at level of T5.. |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- female patient
- American society of anesthesiologists (ASA) I and II physical status
- age from 25 to 70 years old
- scheduled for either left or right modified radical mastectomy (MRM).
Key exclusion criteria (7 listed)
- infection of the skin at or near site of needle puncture
- coagulopathy
- drug hypersensitivity or allergy to the studied drugs
- central or peripheral neuropathy
- significant organ dysfunction cardiac dysrrhythmias
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 |
|---|---|---|
| ultrasound guided erector spinae plan block using bupivacaine for modified radical mastectomyUltrasound guided Erector spinae plane (ESP) block will be given with patient in sitting position depending on surgical site (left or right) ESP block will be given using high frequency linear u/s transducer, the probe is placed in longitudinal orientation lateral to thoracic fifth spinous process, then Trapezius muscle, Rhomboidus major muscle, and erector spinae muscle | Procedure or surgery | Group (C) (control group): |
| ultrasound guided erector spinae plan block with bupivacaine and Dexmetonidine for modified radical mastectomyUltrasound guided Erector spinae plane (ESP) block will be given with patient in sitting position depending on surgical site (left or right) ESP block will be given using high frequency linear u/s transducer, the probe is placed in longitudinal orientation lateral to thoracic fifth spinous process, then Trapezius muscle, Rhomboidus major muscle, and erector spinae muscle | Procedure or surgery | Group (D) (Dexmetonidine group): |
| ultrasound guided erector spinae plan block with bupivacaine and magnesium slphate for modified radical mastectomyUltrasound guided Erector spinae plane (ESP) block will be given with patient in sitting position depending on surgical site (left or right) ESP block will be given using high frequency linear u/s transducer, the probe is placed in longitudinal orientation lateral to thoracic fifth spinous process, then Trapezius muscle, Rhomboidus major muscle, and erector spinae muscle | Procedure or surgery | Group (M) (magnesium slphate group): |
Primary outcome
analgesia requirement
Time frame: 24 hours
first request for analgesia and total analgesia requirements
1 secondary outcome
chronic pain assessment
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2021.
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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.
peter R Edward, MSc principal investigator
specialist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing ultrasound guided erector spinae plan block using bupivacaine for modified radical mastectomy, ultrasound guided erector spinae plan block with bupivacaine and Dexmetonidine for modified radical mastectomy and ultrasound guided erector spinae plan block with bupivacaine and magnesium slphate for modified radical mastectomy in people with Pain, Postoperative, 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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 1 Feb 2021. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Results are not available in the source record.
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?
analgesia requirement (time frame: 24 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 1 Feb 2021.