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Acute PainPhase 2/3NCT04732390

Analgesic Efficacy of Magnesium Sulphate as an Adjuvant to Levobupivacaine in Erector Spinae Block for Acute Pain Management in Modified Radical Mastectomy

A Phase 2/3 study testing erector spinae block with bupivacaine and erector spinae block with bupivacaine and magnesium sulphate in people with Acute Pain, run by South Egypt Cancer Institute at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To evaluate the analgesic efficacy of magnesium sulphate as adjuvants to levobupivacaine in erector spinae plane block in modified radical mastectomy surgery for acute pain management 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 magnesium sulphate
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 Dec 2019to 1 Jul 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
  • South Egypt Cancer Institute

    Asyut, 171516

    peter R Edward, MSc, 1224083376 ext. 0020, Peter_rafaat85@yahoo.com

    Recruiting

Other trials in Egypt

About this study

To evaluate the analgesic efficacy of magnesium sulphate as adjuvants to levobupivacaine in erector spinae plane block in modified radical mastectomy surgery for acute pain management

Read the detailed description

The participating female will be randomly allocated using computer generated randomization program (http://www.randoiler.org) into one of 2 groups.

Group (C) / (I):20 patients (control group):

Patient will receive 20 ml 0.25% levobupivacaine into interfascial plane below erector spinae muscle at level of T5.

Group (M) / (III): 20 patients (magnesium slphate group):

Patient will receive 20ml 0.25% levobupivacaine 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 protocol

Pre-operative and post-operative procedure:

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:

  1. Vital signs (heart rate, noninvasive blood pressure, and oxygen saturation).
  2. 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)
  3. 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 magnesium sulphate
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

    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 magnesium sulphateProcedure or surgery

    Patient will receive 20ml 0.25% levobupivacaine + 0.7 mg/kg MgSo4 into interfascial plane below erector spinae muscle at level of T5.

Study groups in NCT04732390
Study groupRoleWhat they receive
GROUP(A) (CONTROL GROUP)Placebo comparatorPatient 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 (M)Active comparatorPatient will receive 20ml 0.25% levobupivacaine + 0.7 mg/kg MgSo4 into interfascial plane below erector spinae muscle at level of T5. .
Receives: Procedure: erector spinae block with bupivacaine and magnesium sulphate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. analgesia request

    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.

  1. First posted1 Feb 2021
  2. Study start1 Dec 2019
  3. Primary completion1 Feb 2021 (estimated)
  4. Study completion1 Jul 2021 (estimated)

Resources

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)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04732390
Sponsor's protocol ID
peter 2 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

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 magnesium sulphate 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 request (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.

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