AnalgesiaNCT05851768
Efficacy of Dexmedetomidine VS Magnesium Sulphate With Bupivacaine in Erector Spinae Block for Thoracotomy Pain
A study testing Bupivacaine, Bupivacaine + Magnesium and Bupivacaine + Dexmedetomidine in people with Analgesia, run by National Cancer Institute, Egypt at 1 site in Egypt.
Trial summary
Postoperative pain management is considered an integral part of perioperative care in patients undergoing thoracotomy. In order to reduce these complications, multiple regional techniques have been developed for thoracotomy including Intercostal nerve block, Erectospinae plane block and serratus block. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Analgesia
- What is being tested?
- Bupivacaine, Bupivacaine + Magnesium and Bupivacaine + Dexmedetomidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 15 May 2023to 27 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from 18 to 65 years.
- Male and female sexes.
- ASA I-II.,III
- Cancer patients undergoing thoracotomy incisions
- Body mass index (BMI) from 18.5 to 30 kg/m2
Who cannot join
- Patient refusal
- Known allergy to any of the used drugs
- Low platelet count, any coagulation defect
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Walaa Y Elsabeeny
Cairo, 11796
Walaa Y Elsabeeny, MD, +201007798466, walaa.elsabeeny@nci.cu.edu.eg
About this study
Official title: Analgesic Efficacy of Adding Dexmedetomidine VS Magnesium Sulphate as Adjuvants With Bupivacaine in Ultrasound-guided Erector Spinae Plane Block for Post Thoracotomy Pain
Postoperative pain management is considered an integral part of perioperative care in patients undergoing thoracotomy. In order to reduce these complications, multiple regional techniques have been developed for thoracotomy including Intercostal nerve block, Erectospinae plane block and serratus block. Multiple adjuvants have been used in regional analgesia including adrenaline,clonidine,magnesium sulphate,dexmedatomidine and opoids.
- Conditions
- Analgesia
- Being tested
- Bupivacaine, Bupivacaine + Magnesium, Bupivacaine + Dexmedetomidine
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
Bupivacaine 0.25%
Bupivacaine + MagnesiumDrug
Bupivacaine 0.25% + Magnesium
Bupivacaine + DexmedetomidineDrug
Bupivacaine 0.25% + Dexmedetomidine
| Study group | Role | What they receive |
|---|---|---|
| Erector spinae plane block with 0.25% bupivacaine | Active comparator | Patients will receive ultrasound guided ESPB with 0.25% bupivacaine Receives: Drug: Bupivacaine |
| Erector spinae plane block with 0.25% bupivacaine and Magnesium | Experimental | Patients will receive ultrasound guided ESPB with 0.25% bupivacaine and magnesium Receives: Drug: Bupivacaine + Magnesium |
| Erector spinae plane block with 0.25% bupivacaine and Dexmedetomidine | Experimental | Patients will receive ultrasound guided ESPB with 0.25% bupivacaine and dexmedetomidine Receives: Drug: Bupivacaine + Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total postoperative morphine consumption
Total dose of morphine needed postoperatively in the first 24 h
Measured: First 24 hours postoperatively
Secondary outcomes (1)
Time to first postoperative rescue analgesia.
Time to first postoperative rescue analgesia.
Measured: First 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2023
- Study start15 May 2023
- Primary completion25 Nov 2026 (estimated)
- Study completion27 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Walaa Youssef Elsabeeny, National Cancer Institute, Egypt
- Investigators
- Walaa Y Elsabeeny, MD, Principal investigator, Assistant professor of Anesthesia and Pain Management, National Cancer Institute, Cairo UniversityAhmed A Mohamed, MD, Study director, Professor of Anesthesia,Surgical intensive care and Pain management,Faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05851768
- Sponsor's protocol ID
- N-80-2022/NSC
- Status last verified
- Jun 2026
- First submitted
- 1 May 2023
- Last updated
- 30 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Information is available upon reasonable request through contacting the corresponding investigator
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of Adding Dexmedetomidine VS Magnesium Sulphate as Adjuvants With Bupivacaine in Ultrasound-guided Erector Spinae Plane Block for Post Thoracotomy Pain
- ClinicalTrials.gov ID
- NCT05851768
- Acronym / sponsor ID
- N-80-2022/NSC
- Conditions
- Analgesia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Cancer Institute, EgyptUniversity, hospital or other
- Study start
- 15 May 2023 (actual)
- Primary completion
- 25 Nov 2026 (estimated)
- Study completion
- 27 Dec 2026 (estimated)
- First posted
- 10 May 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.
Postoperative pain management is considered an integral part of perioperative care in patients undergoing thoracotomy. In order to reduce these complications, multiple regional techniques have been developed for thoracotomy including Intercostal nerve block, Erectospinae plane block and serratus block. Multiple adjuvants have been used in regional analgesia including adrenaline,clonidine,magnesium sulphate,dexmedatomidine and opoids.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Erector spinae plane block with 0.25% bupivacaine | Active comparator | Drug: BupivacainePatients will receive ultrasound guided ESPB with 0.25% bupivacaine |
| Erector spinae plane block with 0.25% bupivacaine and Magnesium | Experimental | Drug: Bupivacaine + MagnesiumPatients will receive ultrasound guided ESPB with 0.25% bupivacaine and magnesium |
| Erector spinae plane block with 0.25% bupivacaine and Dexmedetomidine | Experimental | Drug: Bupivacaine + DexmedetomidinePatients will receive ultrasound guided ESPB with 0.25% bupivacaine and dexmedetomidine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age from 18 to 65 years.
- Male and female sexes.
- ASA I-II.,III
- Cancer patients undergoing thoracotomy incisions
- Body mass index (BMI) from 18.5 to 30 kg/m2
Key exclusion criteria (3 listed)
- Patient refusal
- Known allergy to any of the used drugs
- Low platelet count, any coagulation defect
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 |
|---|---|---|
| BupivacaineBupivacaine 0.25% | Drug | Erector spinae plane block with 0.25% bupivacaine |
| Bupivacaine + MagnesiumBupivacaine 0.25% + Magnesium | Drug | Erector spinae plane block with 0.25% bupivacaine and Magnesium |
| Bupivacaine + DexmedetomidineBupivacaine 0.25% + Dexmedetomidine | Drug | Erector spinae plane block with 0.25% bupivacaine and Dexmedetomidine |
Primary outcome
Total postoperative morphine consumption
Time frame: First 24 hours postoperatively
Total dose of morphine needed postoperatively in the first 24 h
1 secondary outcome
Time to first postoperative rescue analgesia.
Time frame: First 24 hours postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Individual participant dataSharing planned: Undecided. Information is available upon reasonable request through contacting the corresponding investigator
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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.
Walaa Y Elsabeeny, MD principal investigator
Assistant professor of Anesthesia and Pain Management, National Cancer Institute, Cairo University
Ahmed A Mohamed, MD study director
Professor of Anesthesia,Surgical intensive care and Pain management,Faculty of medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bupivacaine, Bupivacaine + Magnesium and Bupivacaine + Dexmedetomidine in people with Analgesia, run by National Cancer Institute, Egypt 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 5 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 30 Jun 2026. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Walaa Y Elsabeeny, MD (01007798466 ext. +2, walaa.elsabeeny@nci.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total postoperative morphine consumption (time frame: First 24 hours postoperatively). 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 30 Jun 2026.