Postoperative PainNCT04433624
Analgesic Efficacy of the Erector Spinae Plane Block Using Bupivacaine Versus Bupivacaine/Magnesium Sulphate in Patients Undergoing Lumbar Spine Surgery
A study testing Group (B) in people with Postoperative Pain, run by Beni-Suef University at 1 site in Egypt.
Trial summary
Introduction: Severe postoperative pain following spine surgery is a significant cause of morbidity, extended length of facility stay, and marked opioid usage The analgesic regime for postoperative pain usually includes paracetamol,NSAIDs and opioids. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Group (B)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Jul 2020to 10 Dec 2020
- Phase
- Interventional
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- orthopedic
- neurological patients
- undergoing posterior lumbar spine fusion
- American Society of Anesthesiologists (ASA) physical status 1 or 2.
Who cannot join
- Contraindications for regional blocks
- allergic reaction to drugs.
- Patients with a history of liver, renal, heart and vascular failure, cardiac conduction disturbance.
- opium addiction, any drug or substance abuse and chronic treatment with opium, non-steroidal anti-inflammatory drugs and calcium channel blockers (CCB).
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Banī Suwayf, Egypt, 11391
Banī Suwayf
Doaa Rashwan, MD, 01011270763, doaa_rashwan@hotmail.com
About this study
Introduction:
Severe postoperative pain following spine surgery is a significant cause of morbidity, extended length of facility stay, and marked opioid usage
The analgesic regime for postoperative pain usually includes paracetamol,NSAIDs and opioids. The opioid epidemic as well as the opioid side effects2 (sedation,respiratory depression, constipation, delayed patient mobilization) has led perioperative physicians to find a way of decreasing the use of opioids. Increasing the use of regional anesthesia is one of the measures to this end. Ultrasound-guided erector spinae plane block (ESP) is a-- popular, interfascial regional technique that was initially described for the management of thoracic neuropathic pain . As the erector spinae fascia extends from the nuchal fascia cranially to the sacrum caudally, local anesthetic agents extend through several levels, and the block can be effective over a large area The ESP block provides effective postoperative analgesic effect for 24 hours in patients undergoing lumbar spinal surgery Magnesium sulfate (MGS) is a noncompetitive antagonist of N-methyl, D-aspartate (NMDA) receptors with an analgesic effect and is essential for release of acetylcholine from the presynaptic terminals and, similar to calcium channel blockers (CCB), can prevent the entry of calcium into the cell It is suggested that magnesium has many important roles to play in nociception
Read the detailed description
The aim of this study is to evaluate the efficacy of the Erector Spinae Plane Block using bupivacaine versus bupivacaine/magnesium sulphate in Patients Undergoing Lumbar Spine surgery
Inclusion criteria:
orthopedic and neurological patients undergoing posterior lumbar spine fusion [American Society of Anesthesiologists (ASA) physical status 1 or 2.
Exclusion Criteria:
- -Contraindications for regional blocks (eg. Patient refusal Infection at the injection site, coagulopathy)
- allergic reaction to drugs.
- Patients with a history of liver, renal, heart and vascular failure, cardiac conduction disturbance.
- opium addiction, any drug or substance abuse and chronic treatment with opium, non-steroidal anti-inflammatory drugs and calcium channel blockers (CCB).
The patients will be blinded to the study drugs and will be randomly assigned into two equal groups by opaque sealed envelope as follows:
Group (B) (n=15): will receive The bilateral ESP blocks were performed by injecting 40 mL of 0.25% bupivacaine (20 mL into each side) into the fascial plane between the deep surface of the erector spinae muscle and the transverse processes of the lumbar vertebrae
Group B MG (n=15): will receive bilateral ESP blocks performed by each side) and and 500 mg magnesium sulphate into the fascial plane between the deep surface of the erector spinae muscle and the transverse processes of the lumbar vertebrae for pain management after lumbar spinal surgery injecting 40 mL of 0.25% bupivacaine(20 mL into each side)
- Conditions
- Postoperative Pain
- Being tested
- Group (B)
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group (B)Other
Group (B) (n=15): will receive The bilateral ESP blocks were performed by injecting 40 mL of 0.25% bupivacaine (20 mL into each side) into the fascial plane between the deep surface of the erector spinae muscle and the transverse processes of the lumbar vertebrae
| Study group | Role | What they receive |
|---|---|---|
| Group (B) | Active comparator | will receive The bilateral ESP blocks before surgery Receives: Other: Group (B) |
| Group B MG | Active comparator | will receive bilateral ESP blocks performed by each side) before surgery Receives: Other: Group (B) |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to first request of analgesics in hours
time to first request of analgesics by the pateint in hours
Measured: change from base line for 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start18 Jul 2020 (estimated)
- Primary completion10 Dec 2020 (estimated)
- Study completion10 Dec 2020 (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.
- More trials run by Beni-Suef 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, doaa rashwan, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04433624
- Sponsor's protocol ID
- FMBSUREC/07062020/Abd El Badei
- Status last verified
- Jul 2020
- First submitted
- 11 Jun 2020
- Last updated
- 17 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of the Erector Spinae Plane Block Using Bupivacaine Versus Bupivacaine/Magnesium Sulphate in Patients Undergoing Lumbar Spine Surgery
- ClinicalTrials.gov ID
- NCT04433624
- Acronym / sponsor ID
- FMBSUREC/07062020/Abd El Badei
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 18 Jul 2020 (estimated)
- Primary completion
- 10 Dec 2020 (estimated)
- Study completion
- 10 Dec 2020 (estimated)
- First posted
- 16 Jun 2020 (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.
Introduction:
Severe postoperative pain following spine surgery is a significant cause of morbidity, extended length of facility stay, and marked opioid usage
The analgesic regime for postoperative pain usually includes paracetamol,NSAIDs and opioids. The opioid epidemic as well as the opioid side effects2 (sedation,respiratory depression, constipation, delayed patient mobilization) has led perioperative physicians to find a way of decreasing the use of opioids. Increasing the use of regional anesthesia is one of the measures to this end. Ultrasound-guided erector spinae plane block (ESP) is a-- popular, interfascial regional technique that was initially described for the management of thoracic neuropathic pain . As the erector spinae fascia extends from the nuchal fascia cranially to the sacrum caudally, local anesthetic agents extend through several levels, and the block can be effective over a large area The ESP block provides effective postoperative analgesic effect for 24 hours in patients undergoing lumbar spinal surgery Magnesium sulfate (MGS) is a noncompetitive antagonist of N-methyl, D-aspartate (NMDA) receptors with an analgesic effect and is essential for release of acetylcholine from the presynaptic terminals and, similar to calcium channel blockers (CCB), can prevent the entry of calcium into the cell It is suggested that magnesium has many important roles to play in nociception
Detailed description
The aim of this study is to evaluate the efficacy of the Erector Spinae Plane Block using bupivacaine versus bupivacaine/magnesium sulphate in Patients Undergoing Lumbar Spine surgery
Inclusion criteria:
orthopedic and neurological patients undergoing posterior lumbar spine fusion [American Society of Anesthesiologists (ASA) physical status 1 or 2.
Exclusion Criteria:
- -Contraindications for regional blocks (eg. Patient refusal Infection at the injection site, coagulopathy)
- allergic reaction to drugs.
- Patients with a history of liver, renal, heart and vascular failure, cardiac conduction disturbance.
- opium addiction, any drug or substance abuse and chronic treatment with opium, non-steroidal anti-inflammatory drugs and calcium channel blockers (CCB).
The patients will be blinded to the study drugs and will be randomly assigned into two equal groups by opaque sealed envelope as follows:
Group (B) (n=15): will receive The bilateral ESP blocks were performed by injecting 40 mL of 0.25% bupivacaine (20 mL into each side) into the fascial plane between the deep surface of the erector spinae muscle and the transverse processes of the lumbar vertebrae
Group B MG (n=15): will receive bilateral ESP blocks performed by each side) and and 500 mg magnesium sulphate into the fascial plane between the deep surface of the erector spinae muscle and the transverse processes of the lumbar vertebrae for pain management after lumbar spinal surgery injecting 40 mL of 0.25% bupivacaine(20 mL into each side)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group (B) | Active comparator | Other: Group (B)will receive The bilateral ESP blocks before surgery |
| Group B MG | Active comparator | Other: Group (B)will receive bilateral ESP blocks performed by each side) before surgery |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- orthopedic
- neurological patients
- undergoing posterior lumbar spine fusion
- American Society of Anesthesiologists (ASA) physical status 1 or 2.
Key exclusion criteria (4 listed)
- Contraindications for regional blocks
- allergic reaction to drugs.
- Patients with a history of liver, renal, heart and vascular failure, cardiac conduction disturbance.
- opium addiction, any drug or substance abuse and chronic treatment with opium, non-steroidal anti-inflammatory drugs and calcium channel blockers (CCB).
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 |
|---|---|---|
| Group (B)Group (B) (n=15): will receive The bilateral ESP blocks were performed by injecting 40 mL of 0.25% bupivacaine (20 mL into each side) into the fascial plane between the deep surface of the erector spinae muscle and the transverse processes of the lumbar vertebrae | Other | Group (B), Group B MG |
Primary outcome
time to first request of analgesics in hours
Time frame: change from base line for 24 hours
time to first request of analgesics by the pateint in hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2020.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group (B) in people with Postoperative Pain, run by Beni-Suef 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 4 inclusion and 4 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 17 Jul 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact doaa rashwan, md (00201011270763, doaa_rashwan@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time to first request of analgesics in hours (time frame: change from base line for 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 17 Jul 2020.