Acute PainPhase 2/3NCT04732377
Analgesic Efficacy of Dexmedetomidine as Adjuvant to Levobupivacaine in Ultrasound-guided Erector Spinae Plan Block for Modified Radical Mastectomy
A Phase 2/3 study testing erector spinae block with bupivacaine and erector spinae block with bupivacaine and dexmedetomidine in people with Acute Pain, run by South Egypt Cancer Institute at 1 site in Egypt.
Trial summary
To evaluate the analgesic efficacy of dexmedetomidine as adjuvants to levobupivacaine in erector spinae plane block in modified radical mastectomy surgery. Read more about this study
- Who is it for?
- Ages 25 to 70 years, women only
- Conditions the study is for
- Acute Pain
- What is being tested?
- erector spinae block with bupivacaine and erector spinae block with bupivacaine and dexmedetomidine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2020to 28 Dec 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
- No healthy volunteers
- 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.
Egypt1 site, 1 recruiting
- Recruiting
South Egypt Cancer Institute
Asyut, 171516
peter R Edward, MSc, 1224083376 ext. 0020, Peter_rafaat85@yahoo.com
About this study
To evaluate the analgesic efficacy of dexmedetomidine as adjuvants to levobupivacaine in erector spinae plane block in modified radical mastectomy surgery.
Read the detailed description
Premedication will be given, after complete fasting hours after applying standard monitors (noninvasive blood pressure, pulse oximetery, ECG, temperature and capnography), an intravenous cannula will be placed and secured.
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, are identified from surface, we deposite20 ml of 0.25% levobupivacaine into interfacial plane below erector spinae muscle.
General anesthesia will be induced with fentanyl l μg /kg, propofol 2mg /kg, muscle relaxant (atracurium 0.5 mg/kg) inhalational anesthesia (isoflurane or sevoflurane) No other narcotic, analgesic or sedative will be administrated during operative period.
Standard monitor (mean arterial blood pressure, heart rate , oxygen saturation \& end-tidal Co2) will observed and recorded every 30 min till end of surgery
Post-operative:
The patient will be transferred to the post anesthesia care unit (PACU) and will be monitored for:
- Vital signs (heart rate, noninvasive blood pressure, and oxygen saturation).
- RASS score (Richmond Agitation \& Sedation scale) with its +4:-5 score range will be used to assess sedation post-operative, considered sedation ≥-2 table (1)
- Numerical Rating Score (NRS) pain score with its 0-10 score range will be used to assess pain immediately post-operative and then at 2, 4, 6, 8, 12,18and 24hour in the post-operative period figure (1). (4)Time and amount to request analgesia (PCA patient controlled analgesia morphine (demand dose 1-2 mg, lock out 6-10 min)) at NRS≥3. (5) Side effect of studied drugs as (hypotension, sedation , respiration depression and vomiting ) and complication of the block for 24h post- operative.
- Conditions
- Acute Pain
- Being tested
- erector spinae block with bupivacaine, erector spinae block with bupivacaine and dexmedetomidine
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
erector spinae block with bupivacaineProcedure or surgery
Group (A) (control group):
Patient will receive 20 ml 0.25% levobupivacaine into interfascial plane below erector spinae muscle at level of T5.
erector spinae block with bupivacaine and dexmedetomidineProcedure or surgery
Patient will receive 20ml 0.25% levobupivacaine above + 1μ/kg dexmedetomidine into interfascial plane below erector spinae muscle at level of T5.
| Study group | Role | What they receive |
|---|---|---|
| GROUP(A) (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: erector spinae block with bupivacaine |
| Group (D) | Active comparator | Patient will receive 20ml 0.25% levobupivacaine above + 1μ/kg dexmedetomidine into interfascial plane below erector spinae muscle at level of T5. Receives: Procedure: erector spinae block with bupivacaine and dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analgesia required
time of first request for analgesia.
Measured: 24 hours
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 start1 Nov 2020
- Primary completion28 Nov 2021 (estimated)
- Study completion28 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PainStudies 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
- 40 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
- NCT04732377
- Sponsor's protocol ID
- peter 3 SECI
- Status last verified
- Jan 2021
- First submitted
- 9 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 Dexmedetomidine as Adjuvant to Levobupivacaine in Ultrasound-guided Erector Spinae Plan Block for Modified Radical Mastectomy
- ClinicalTrials.gov ID
- NCT04732377
- Acronym / sponsor ID
- peter 3 SECI
- Conditions
- Acute Pain
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- South Egypt Cancer InstituteUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 28 Nov 2021 (estimated)
- Study completion
- 28 Dec 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 evaluate the analgesic efficacy of dexmedetomidine as adjuvants to levobupivacaine in erector spinae plane block in modified radical mastectomy surgery.
Detailed description
Premedication will be given, after complete fasting hours after applying standard monitors (noninvasive blood pressure, pulse oximetery, ECG, temperature and capnography), an intravenous cannula will be placed and secured.
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, are identified from surface, we deposite20 ml of 0.25% levobupivacaine into interfacial plane below erector spinae muscle.
General anesthesia will be induced with fentanyl l μg /kg, propofol 2mg /kg, muscle relaxant (atracurium 0.5 mg/kg) inhalational anesthesia (isoflurane or sevoflurane) No other narcotic, analgesic or sedative will be administrated during operative period.
Standard monitor (mean arterial blood pressure, heart rate , oxygen saturation \& end-tidal Co2) will observed and recorded every 30 min till end of surgery
Post-operative:
The patient will be transferred to the post anesthesia care unit (PACU) and will be monitored for:
- Vital signs (heart rate, noninvasive blood pressure, and oxygen saturation).
- RASS score (Richmond Agitation \& Sedation scale) with its +4:-5 score range will be used to assess sedation post-operative, considered sedation ≥-2 table (1)
- Numerical Rating Score (NRS) pain score with its 0-10 score range will be used to assess pain immediately post-operative and then at 2, 4, 6, 8, 12,18and 24hour in the post-operative period figure (1). (4)Time and amount to request analgesia (PCA patient controlled analgesia morphine (demand dose 1-2 mg, lock out 6-10 min)) at NRS≥3. (5) Side effect of studied drugs as (hypotension, sedation , respiration depression and vomiting ) and complication of the block for 24h post- operative.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GROUP(A) (CONTROL GROUP) | Placebo comparator | Procedure: erector spinae block with bupivacainePatient will receive 20 ml 0.25% levobupivacaine into interfascial plane below erector spinae muscle at level of T5. |
| Group (D) | Active comparator | Procedure: erector spinae block with bupivacaine and dexmedetomidinePatient will receive 20ml 0.25% levobupivacaine above + 1μ/kg dexmedetomidine into interfascial plane below erector spinae muscle at level of T5. |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not 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 |
|---|---|---|
| erector spinae block with bupivacaineGroup (A) (control group): Patient will receive 20 ml 0.25% levobupivacaine into interfascial plane below erector spinae muscle at level of T5. | Procedure or surgery | GROUP(A) (CONTROL GROUP) |
| erector spinae block with bupivacaine and dexmedetomidinePatient will receive 20ml 0.25% levobupivacaine above + 1μ/kg dexmedetomidine into interfascial plane below erector spinae muscle at level of T5. | Procedure or surgery | Group (D) |
Primary outcome
Analgesia required
Time frame: 24 hours
time of first request for analgesia.
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 erector spinae block with bupivacaine and erector spinae block with bupivacaine and dexmedetomidine in people with Acute Pain, 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?
Contact peter R Edward, MSc (1224083376 ext. 0020, Peter_rafaat85@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analgesia required (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.