Anesthesia , AnalgesiaPhase 3NCT05671081
Dexmedetomidine Versus Magnesium Sulfate in Ultrasound Guided Bilateral Bi-level Erector Spinae Plane Block in Corrective Scoliosis Surgery
A Phase 3 study testing Dexmedetomidine, Magnesium sulfate and Narcotic Analgesics in people with Anesthesia , Analgesia, run by Ain Shams University at 1 site in Egypt.
Trial summary
Posterior spinal fusion for scoliosis surgery may lead to severe postoperative pain which requires significant opioid use for adequate perioperative analgesia. This postoperative pain extends the time of recovery, and thus, safe, and efficient methods for perioperative analgesia are crucial and advantageous for early… Read more about this study
- Who is it for?
- Ages 14 to 25 years
- Conditions the study is for
- Anesthesia , Analgesia
- What is being tested?
- Dexmedetomidine, Magnesium sulfate and Narcotic Analgesics
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Jan 2023to 15 Mar 2024
- 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 14 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- patients who will be scheduled for indicated open corrective scoliosis surgery in the prone position.
- physical status American Society of Anesthesiologists (ASA) I or II.
Who cannot join
- patients refuse to participate.
- . -ASA physical status >II.
- patients who have contraindications to regional analgesic procedures as infection at injection site
- patients who have major illnesses (e.g., cardiac, respiratory, renal, hepatic or neurological).
- allergy to the study drugs
- a known history of recent opioid use
Show all 11Show fewer
- obesity (body mass index (BMI) > 35 kg/m2)
- those who underwent revision surgery
- coagulopathy
- drug or alcohol abuse
- epilepsy, or a psychiatric illness that would interfere with the perception and assessment of pain.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dexmedetomidine Versus Magnesium Sulfate in Ultrasound Guided Bilateral Bi-level Erector Spinae Plane Block in Corrective Scoliosis Surgery: A Randomized Controlled Clinical Trial.
Posterior spinal fusion for scoliosis surgery may lead to severe postoperative pain which requires significant opioid use for adequate perioperative analgesia. This postoperative pain extends the time of recovery, and thus, safe, and efficient methods for perioperative analgesia are crucial and advantageous for early recovery and ambulation.
Traditional opioid-based analgesia techniques are characterized by well-known complications such as vomiting, nausea, sedation, and pruritus. Although regional anesthesia is an essential part of multimodal analgesia, available options are limited. Recently, an ultrasound (US)-guided erector spinae plane block (ESPB) method that anesthetizes ventral and dorsal rami of spinal nerves was introduced for the treatment of both postoperative and neuropathic pain.
Read more
Due to the arousing interest of several physicians, ESPB application is reported to be effective in the breast, weight loss, and lumbosacral spine surgeries as it reduces the need for analgesic drugs. The main advantages of the ESPB are technical simplicity, minimal risk for the spinal cord, and fewer complications.
The ESP block is a fascial plane block that aims to inject a local anesthetic mixture within a plane beneath the erector spinae muscle at the transverse process of the vertebra. ESP block can provide effective postoperative analgesia for upper abdominal surgery when performed at the thoracic vertebra 7-8 level. ESP block acts probably by diffusion of local anaesthetic into the paravertebral space. The advantages of ESP block are its ease of performance and safety. Owing to its superficial location, away from vessels and nerves, the complications associated with paravertebral block can be avoided.
The effect of magnesium was first recognized for the treatment of arrhythmia and preeclampsia, and its effect on anaesthesia and analgesia has recently been recognized. Magnesium sulphate has also been used as an adjunct to anaesthesia in recent years. It is also an effective analgesic agent for perioperative pain. Research has also reported that the intraoperative use of magnesium is characterized by a reduced use of anesthetics and muscle relaxants. Furthermore, opioid use, postoperative nausea and vomiting, hypertension, and shivering have met a decreased trend with the use of magnesium sulphate.
Magnesium sulfate (MgSO4) may be helpful as an analgesic adjuvant in regional anesthesia because it improves and prolongs the analgesic effect of local anesthetics; moreover, MgSO4 alone modulates the transmission of nociceptive stimuli and pain perception by blocking the N-methyl-D-aspartate (NMDA) receptor.
Dexmedetomidine (DE) is a potent α2 adrenoreceptor agonist and it is highly selective for α2 adrenoreceptor seven times more than clonidine. Many studies documented a prolonged duration and rapid onset of sensory block with the perineural injection of DE. Dexmedetomidine has been introduced as an adjuvant to local anaesthetics in both neuroaxial and peripheral nerve blocks. perineural dexmedetomidine has shown to prolong the duration of postoperative analgesia in addition to reducing the opioid consumption.
- Conditions
- Anesthesia , Analgesia
- Being tested
- Dexmedetomidine, Magnesium sulfate, Narcotic Analgesics
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
patients will receive combined general anesthesia and bilateral bilevel at T5 \&T10 Erector spinae plane block with 20mL of bupivacaine 0.125 %. plus 0.5 μg/kgof Dexmedetomidine for each injection
Magnesium sulfateDrug
patients will receive combined general anesthesia and bilateral bilevel at T5 \&T10 Erector spinae plane block with 20mL of bupivacaine 0.125 %. plus 2 mg/kg Magnesium sulfate for each injection
Narcotic AnalgesicsDrug
patients will receive general anesthesia and conventional intraoperative and postoperative analgesia
| Study group | Role | What they receive |
|---|---|---|
| General anethesia +Dexmedetomidine plus Bupivacaine for Erector spinae plane block | Active comparator | Not described Receives: Drug: Dexmedetomidine |
| General anethesia +Magnesium sulfate plus Bupivacaine for Erector spinae plane block | Active comparator | Not described Receives: Drug: Magnesium sulfate |
| general anesthesia+conventional postoperative narcotic analgesia | Active comparator | Not described Receives: Drug: Narcotic Analgesics |
What is being measured
The primary outcome is the main question the study is designed to answer.
First time to analgesic requirement
All patients will receive an IV PCA system (Accufuser M8P, 100 mL: Woo Young Meditech Co, S. Korea). PCA was prepared with 100 mL of isotonic saline containing 50 mg morphine, and the selected system was adjusted to infuse a 5 mL bolus dose with a lockout interval of 15 minutes while the basal flow rate was switched off.
Measured: 1st 48 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2023
- Study start5 Jan 2023
- Primary completion15 Mar 2024
- Study completion15 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia , AnalgesiaStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amin Mohammed Alansary Amin Ahmed Helwa, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05671081
- Sponsor's protocol ID
- FMASU R263/2022
- Status last verified
- Jul 2024
- First submitted
- 1 Jan 2023
- Last updated
- 30 Jul 2024
- 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 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine Versus Magnesium Sulfate in Ultrasound Guided Bilateral Bi-level Erector Spinae Plane Block in Corrective Scoliosis Surgery: A Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT05671081
- Acronym / sponsor ID
- FMASU R263/2022
- Conditions
- Anesthesia , Analgesia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 5 Jan 2023 (actual)
- Primary completion
- 15 Mar 2024 (actual)
- Study completion
- 15 Mar 2024 (actual)
- First posted
- 4 Jan 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.
Posterior spinal fusion for scoliosis surgery may lead to severe postoperative pain which requires significant opioid use for adequate perioperative analgesia. This postoperative pain extends the time of recovery, and thus, safe, and efficient methods for perioperative analgesia are crucial and advantageous for early recovery and ambulation.
Traditional opioid-based analgesia techniques are characterized by well-known complications such as vomiting, nausea, sedation, and pruritus. Although regional anesthesia is an essential part of multimodal analgesia, available options are limited. Recently, an ultrasound (US)-guided erector spinae plane block (ESPB) method that anesthetizes ventral and dorsal rami of spinal nerves was introduced for the treatment of both postoperative and neuropathic pain.
Due to the arousing interest of several physicians, ESPB application is reported to be effective in the breast, weight loss, and lumbosacral spine surgeries as it reduces the need for analgesic drugs. The main advantages of the ESPB are technical simplicity, minimal risk for the spinal cord, and fewer complications.
The ESP block is a fascial plane block that aims to inject a local anesthetic mixture within a plane beneath the erector spinae muscle at the transverse process of the vertebra. ESP block can provide effective postoperative analgesia for upper abdominal surgery when performed at the thoracic vertebra 7-8 level. ESP block acts probably by diffusion of local anaesthetic into the paravertebral space. The advantages of ESP block are its ease of performance and safety. Owing to its superficial location, away from vessels and nerves, the complications associated with paravertebral block can be avoided.
The effect of magnesium was first recognized for the treatment of arrhythmia and preeclampsia, and its effect on anaesthesia and analgesia has recently been recognized. Magnesium sulphate has also been used as an adjunct to anaesthesia in recent years. It is also an effective analgesic agent for perioperative pain. Research has also reported that the intraoperative use of magnesium is characterized by a reduced use of anesthetics and muscle relaxants. Furthermore, opioid use, postoperative nausea and vomiting, hypertension, and shivering have met a decreased trend with the use of magnesium sulphate.
Magnesium sulfate (MgSO4) may be helpful as an analgesic adjuvant in regional anesthesia because it improves and prolongs the analgesic effect of local anesthetics; moreover, MgSO4 alone modulates the transmission of nociceptive stimuli and pain perception by blocking the N-methyl-D-aspartate (NMDA) receptor.
Dexmedetomidine (DE) is a potent α2 adrenoreceptor agonist and it is highly selective for α2 adrenoreceptor seven times more than clonidine. Many studies documented a prolonged duration and rapid onset of sensory block with the perineural injection of DE. Dexmedetomidine has been introduced as an adjuvant to local anaesthetics in both neuroaxial and peripheral nerve blocks. perineural dexmedetomidine has shown to prolong the duration of postoperative analgesia in addition to reducing the opioid consumption.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| General anethesia +Dexmedetomidine plus Bupivacaine for Erector spinae plane block | Active comparator | Drug: Dexmedetomidine |
| General anethesia +Magnesium sulfate plus Bupivacaine for Erector spinae plane block | Active comparator | Drug: Magnesium sulfate |
| general anesthesia+conventional postoperative narcotic analgesia | Active comparator | Drug: Narcotic Analgesics |
Who may qualify
- Ages
- 14 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- patients who will be scheduled for indicated open corrective scoliosis surgery in the prone position.
- physical status American Society of Anesthesiologists (ASA) I or II.
Key exclusion criteria (11 listed)
- patients refuse to participate.
- . -ASA physical status >II.
- patients who have contraindications to regional analgesic procedures as infection at injection site
- patients who have major illnesses (e.g., cardiac, respiratory, renal, hepatic or neurological).
- allergy to the study drugs
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 |
|---|---|---|
| Dexmedetomidinepatients will receive combined general anesthesia and bilateral bilevel at T5 \&T10 Erector spinae plane block with 20mL of bupivacaine 0.125 %. plus 0.5 μg/kgof Dexmedetomidine for each injection | Drug | General anethesia +Dexmedetomidine plus Bupivacaine for Erector spinae plane block |
| Magnesium sulfatepatients will receive combined general anesthesia and bilateral bilevel at T5 \&T10 Erector spinae plane block with 20mL of bupivacaine 0.125 %. plus 2 mg/kg Magnesium sulfate for each injection | Drug | General anethesia +Magnesium sulfate plus Bupivacaine for Erector spinae plane block |
| Narcotic Analgesicspatients will receive general anesthesia and conventional intraoperative and postoperative analgesia | Drug | general anesthesia+conventional postoperative narcotic analgesia |
Primary outcome
First time to analgesic requirement
Time frame: 1st 48 hour
All patients will receive an IV PCA system (Accufuser M8P, 100 mL: Woo Young Meditech Co, S. Korea). PCA was prepared with 100 mL of isotonic saline containing 50 mg morphine, and the selected system was adjusted to infuse a 5 mL bolus dose with a lockout interval of 15 minutes while the basal flow rate was switched off.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Dexmedetomidine, Magnesium sulfate and Narcotic Analgesics in people with Anesthesia , Analgesia, run by Ain Shams University 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 2 inclusion and 11 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: finished, as of the sponsor's last update on 30 Jul 2024. 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.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
First time to analgesic requirement (time frame: 1st 48 hour). 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 Jul 2024.