Postoperative PainPhase 3NCT03979599
Safety and Efficacy of Magnesium Sulphate as an Adjuvant to Levobupivacaine in Ultra-sound Guided Transversus Abdominis Plan Block in Pediatric Abdominal Cancer Surgery
A Phase 3 study testing ultra-sound guided transversus abdominis plan block, magnesium sulphate& levobupivacaine and Levobupivacaine in people with Postoperative Pain, run by South Egypt Cancer Institute at 1 site in Egypt.
Trial summary
To study the efficacy of magnesium sulphate as adjuvant to levobupivacaine in transversus abdominis plane (TAP) block in patient undergoing abdominal cancer surgery. Read more about this study
- Who is it for?
- Ages 1 year to 7 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- ultra-sound guided transversus abdominis plan block, magnesium sulphate& levobupivacaine and Levobupivacaine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Apr 2019to 30 Jun 2023
- 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 1 year to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- patients with (ASA) Ӏ and ӀӀ physical status, aged from 1 to 7 years old and their weight less than 30 Kg of both sex will undergo surgery will be enrolled.
Who cannot join
- Children with infection, hemorrhagic disorders, hypersensitivity to the studied drugs, muscular disorders, central and peripheral neuropathy, organ dysfunction, cardiac problems and unconscious or mentally retarded patients will be excluded
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
south Egypt cancer institute
Asyut
Ahmed K SAyed, specialist, ahmedkamal86anathesia@gmail.com
About this study
To study the efficacy of magnesium sulphate as adjuvant to levobupivacaine in transversus abdominis plane (TAP) block in patient undergoing abdominal cancer surgery.
Read the detailed description
In this randomized study, patients with (ASA) Ӏ and ӀӀ, aged from 1 to 7 years old and their weight less than 30 Kg of both sex will undergo surgery will be enrolled.
A written informed consent from all parents are obtained
- Conditions
- Postoperative Pain
- Being tested
- ultra-sound guided transversus abdominis plan block, magnesium sulphate& levobupivacaine, Levobupivacaine
- Keywords
- TAP, magnisum sulphate
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultra-sound guided transversus abdominis plan blockProcedure or surgery
comparing ultrasound guided transversus abdominis plan block using combination of magnisum sulphate and levobupivacaine versus levobupivacaine
magnesium sulphate& levobupivacaineDrug
magnesium sulphate\& levobupivacaine
LevobupivacaineDrug
levobupivacaine
| Study group | Role | What they receive |
|---|---|---|
| magnesium sulphate& levobupivacaine | Active comparator | Levobupivacaine add to magnisum sulphate Receives: Procedure: ultra-sound guided transversus abdominis plan block; Drug: magnesium sulphate& levobupivacaine |
| levobupivacaine | Placebo comparator | levobupivacaine Receives: Procedure: ultra-sound guided transversus abdominis plan block; Drug: Levobupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain management
pain will be assessed using FLACC score.The Face, Legs, Activity, Cry, Consolability (FLACC) pain score with its 0 - 10 score range will be used to assess pain immediately postoperative and then at 2, 4, 6, 8, 12, 18 and 24 hours in the postoperative period.
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2019
- Study start15 Apr 2019
- Primary completion1 Jun 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group A (control group): patients will receive levobupivacaine 0.25% . Group B (magnesium sulphate group): patients will receive levobupivacaine 0.25% + MgSo4 .
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South Egypt Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Kamal Sayed, South Egypt Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03979599
- Sponsor's protocol ID
- Ahmed-SECI-86
- Status last verified
- Apr 2023
- First submitted
- 4 Jun 2019
- Last updated
- 19 Apr 2023
- 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 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Magnesium Sulphate as an Adjuvant to Levobupivacaine in Ultra-sound Guided Transversus Abdominis Plan Block in Pediatric Abdominal Cancer Surgery
- ClinicalTrials.gov ID
- NCT03979599
- Acronym / sponsor ID
- Ahmed-SECI-86
- Conditions
- Postoperative Pain
- Keywords
- TAP, magnisum sulphate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- South Egypt Cancer InstituteUniversity, hospital or other
- Study start
- 15 Apr 2019 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 7 Jun 2019 (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 study the efficacy of magnesium sulphate as adjuvant to levobupivacaine in transversus abdominis plane (TAP) block in patient undergoing abdominal cancer surgery.
Detailed description
In this randomized study, patients with (ASA) Ӏ and ӀӀ, aged from 1 to 7 years old and their weight less than 30 Kg of both sex will undergo surgery will be enrolled.
A written informed consent from all parents are obtained
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Group A (control group): patients will receive levobupivacaine 0.25% . Group B (magnesium sulphate group): patients will receive levobupivacaine 0.25% + MgSo4 .
| Arm | Type | Receives |
|---|---|---|
| magnesium sulphate& levobupivacaine | Active comparator | Procedure: ultra-sound guided transversus abdominis plan block, Drug: magnesium sulphate& levobupivacaineLevobupivacaine add to magnisum sulphate |
| levobupivacaine | Placebo comparator | Procedure: ultra-sound guided transversus abdominis plan block, Drug: Levobupivacainelevobupivacaine |
Who may qualify
- Ages
- 1 year to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- patients with (ASA) Ӏ and ӀӀ physical status, aged from 1 to 7 years old and their weight less than 30 Kg of both sex will undergo surgery will be enrolled.
Key exclusion criteria (1 listed)
- Children with infection, hemorrhagic disorders, hypersensitivity to the studied drugs, muscular disorders, central and peripheral neuropathy, organ dysfunction, cardiac problems and unconscious or mentally retarded patients will be excluded
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 |
|---|---|---|
| ultra-sound guided transversus abdominis plan blockcomparing ultrasound guided transversus abdominis plan block using combination of magnisum sulphate and levobupivacaine versus levobupivacaine | Procedure or surgery | levobupivacaine, magnesium sulphate& levobupivacaine |
| magnesium sulphate& levobupivacainemagnesium sulphate\& levobupivacaine | Drug | magnesium sulphate& levobupivacaine |
| Levobupivacainelevobupivacaine | Drug | levobupivacaine |
Primary outcome
postoperative pain management
Time frame: one day
pain will be assessed using FLACC score.The Face, Legs, Activity, Cry, Consolability (FLACC) pain score with its 0 - 10 score range will be used to assess pain immediately postoperative and then at 2, 4, 6, 8, 12, 18 and 24 hours in the postoperative period.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2023.
Related trials for Postoperative Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
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.
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 ultra-sound guided transversus abdominis plan block, magnesium sulphate& levobupivacaine and Levobupivacaine in people with Postoperative 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 1 inclusion and 1 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 19 Apr 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed K Sayed, specialist (01010677881, ahmedkamal86anathesia@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative pain management (time frame: one day). 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 19 Apr 2023.