Erector Spinae BlockPhase 4NCT06231979
Adding Dexmedetomidine to Bupivacaine for Bilateral Erector Spinae Block
A Phase 4 study testing Dexmedetomidine, Bupivacain and Normal saline in people with Erector Spinae Block and Lumbar Fusion Surgeries, run by Assiut University.
Trial summary
The aim of this study is to compare the analgesic effect of bilateral US-guided ESPB using bupivacaine alone versus bupivacaine and DEX in lumbar fusion surgeries. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Erector Spinae Block, Lumbar Fusion Surgeries, Dexmedetomidine
- What is being tested?
- Dexmedetomidine, Bupivacain and Normal saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 25 Feb 2024to 1 Oct 2025
- Phase
- Phase 4
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients of both genders
- age between 18-65 years
- American Society of Anesthesiologists (ASA) physical status I-II**
- scheduled for lumbar spine fusion surgeries ( 2 or 3 level lumbar fusion with or without decompression ) under general anesthesia .
Who cannot join
- Patient refusal.
- Patient with chronic use of opioid analgesia.
- Uncooperative patients with communication difficulties, which might prevent a reliable postoperative assessment.
- Contraindication to regional anesthesia (bleeding disorder, use of any anticoagulants, local infection).
- Known allergy to local anesthetics.
About this study
Official title: Effects of Adding Dexmedetomidine to Bupivacaine for Bilateral Erector Spinae Block in Lumbar Fusion Surgeries
The aim of this study is to compare the analgesic effect of bilateral US-guided ESPB using bupivacaine alone versus bupivacaine and DEX in lumbar fusion surgeries.
Read the detailed description
Surgical treatment of adult lumbar spinal disorders is associated with a substantial risk of perioperative complications. The improvement in management and the development of new techniques in anesthesia and surgical sciences have led to substantial reduction of complications related to lumbar spine surgeries.
Understanding these complications is important and valuable for both the patient and the surgeon. Nevertheless, complications represent undesirable consequences of lumbar spine surgery in adult patients.
Degenerative lumbar disease is one of the most common chronic diseases worldwide. The general incidence of lumbar stenosis accompanied by a significant deterioration in the quality of life reaches 5 % among patients aged < 50 years and approximately 10 - 15 % among elderly patients (50 - 70 years old) Moreover, lumbar stenosis appears to be one of the most common causes of decompression and fusion interventions in the lumbar spine in > 50 years old patients Lumbar surgeries refer to any type of surgical intervention involving any lumbar spine or lower back (between one or more of the L1 - S1 level), including operations for trauma and deformity. The complexity of procedures leads to an increase in comorbidities Major lumbar spine surgery causes severe postoperative pain, which typically persists for at least three days Risk factors most frequently associated with mortality include but are not limited to patients' age, sex, and comorbidity status Postoperative pain is one of the most troublesome pains for the surgical patients and is one of the causes of morbidity and prolonged hospital stay. Various studies have reported that maximal pain occurs in the first 4 postoperative hours and gradually declines by the third postoperative day .
Opiates and non-steroidal anti-inflammatory drugs have been routinely used across the world. Recent resurge of regional anesthetic techniques offer some advantages, especially reduced postoperative nausea and vomiting and less sedation .
Ultrasound (US)-guided erector spinae plane blockade (ESPB) was first developed by Forero in 2016 as an easy and safe way of managing thoracic neuropathic pain. Since that time, this block has gained in popularity and has been used to effectively provide analgesia for a variety of surgeries, including spine surgery .
Erector spinae plane blockade may also have a better safety profile when compared with neuraxial analgesia, perhaps because of direct visualization of the needle under ultrasonography guidance and the ease of placement, although this has not been decisively proven One disadvantage of this block is the short duration of action after a single injection Dexmedetomidine (DEX), is a highly selective and potent central alpha-2 adrenergic receptor agonist. Administration of this adjuvant in miscellaneous methods has received considerable attention in recent years Due to its analgesic and sedative effects, besides the lack of any respiratory-sparing effects, administration of this adjuvant is effective in reducing the need for opioids in the perioperative period and may even result in cooperative sedation.
The neuraxial administration of dexmedetomidine has nociceptive effects on somatic and visceral pains. It also reduces postoperative pain and prolongs analgesia.
Local anesthetic combined with DEX has been reported to prolong analgesia following several blocks. However, it is presently unclear whether adjuncts such as DEX will significantly prolong the duration of ESPB in lumbar fusion surgery.
Oxidative stress is a condition caused by an imbalance between the production and accumulation of reactive oxygen species (ROS) and the body's ability to detoxify these products.
An excess of ROS causes damage to all cellular components. The process of oxidative stress causes the peroxidation of lipids and proteins, the formation of lipid peroxides, DNA fragmentation, and the development of cell death.
ROS activity is usually assessed indirectly by measuring stable products derived from the interaction of these radicals with cellular components. The most-studied cellular antioxidants are superoxide dismutase (SOD) , glutathione peroxidase 1 (GPX1) and human malondialdehyde (MDA).
These enzymes provide the first line of defense against tissue damage caused by ROS. As part of the antioxidant pathway, SOD accelerates the conversion of superoxide to H2O2, while catalase and GPX convert H2O2 to water. SOD and GPX can be measured in serum or plasma to establish the levels of oxidative stress and antioxidant capacity of the body.
- Being tested
- Dexmedetomidine, Bupivacain, Normal saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called DEX
1 μg/kg Dexmedetomidine per side in erector spinae block
BupivacainDrug
Also called Bup
18 mL of bupivacaine 0.25 % per side in erector spinae block
Normal salineDrug
Also called Normal saline sodium chloride 0.9%
2 ml normal saline 0.9% per side in erector spinae block
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine group | Experimental | Patients will receive US-guided ESPB with 18 mL of bupivacaine 0.25 % and 1 μg/kg DEX diluted with saline to reach total volume 20 mL per side. Receives: Drug: Dexmedetomidine; Drug: Bupivacain |
| Bupivacaine group | Experimental | Patients will receive US-guided ESPB with 18 mL of bupivacaine 0.25 % and 2 mL normal saline 0.9 % per side as control group. Receives: Drug: Bupivacain; Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
the cummulative opioid consumption during first 48 h postoperatively.
Measured: 48 hours postoperatively.
Secondary outcomes (2)
Change in stress marker Super Oxide Dismutase (SOD) .
Change in stress marker Super Oxide Dismutase (SOD) level in serum after centrifugation between preoperative at time of cannulation and 24h. Postoperative.
Measured: 24 hours postoperative.
Postoperative pain score using Visual Analogue Scale (VAS).
Measured: immediately postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start25 Feb 2024 (estimated)
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Erector Spinae BlockStudies of the same condition, open and under way.
- More trials run by Assiut 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Ali Hassan Refaat AL-Quossi, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06231979
- Sponsor's protocol ID
- Erector Spinae Block
- Status last verified
- Jan 2024
- First submitted
- 24 Dec 2023
- Last updated
- 30 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kalff R, Ewald C, Waschke A, Gobisch L, Hopf C. Degenerative lumbar spinal stenosis in older people: current treatment options. Dtsch Arztebl Int. 2013 Sep;110(37):613-23; quiz 624. doi: 10.3238/arztebl.2013.0613. Epub 2013 Sep 13.
PubMed 24078855Liu C, Guo C, Meng F, Zhu Z, Xia W, Liu H. Perioperative risk factors related to complications of lumbar spine fusion surgery in elderly patients. BMC Musculoskelet Disord. 2023 Jul 14;24(1):573. doi: 10.1186/s12891-023-06689-z.
PubMed 37452304Dhillon KS. Spinal Fusion for Chronic Low Back Pain: A 'Magic Bullet' or Wishful Thinking? Malays Orthop J. 2016 Mar;10(1):61-68.
PubMed 28435551Proietti L, Scaramuzzo L, Schiro' GR, Sessa S, Logroscino CA. Complications in lumbar spine surgery: A retrospective analysis. Indian J Orthop. 2013 Jul;47(4):340-5. doi: 10.4103/0019-5413.114909.
PubMed 23960276El-Sadawy Ali Eid M, Ibrahim Mohamed Hashesh M and Ahmed El-Badawy Mohamed M. Comparative Study Between Bupivacaine Alone Versus Bupivacaine With Fentanyl, And Bupivacaine With Dexamethasone In Ultrasound Guided Erector Spinae Plane Block For Postoperative Pain Relief In Patients Undergoing Lumber Spine Surgeries. Al-Azhar Medical Journal. 2022;51(1):507-18.
Poorman GW, Moon JY, Wang C, Horn SR, Beaubrun BM, Bono OJ, Francis AM, Jalai CM, Passias PG. Rates of Mortality in Lumbar Spine Surgery and Factors Associated With Its Occurrence Over a 10-Year Period: A Study of 803,949 Patients in the Nationwide Inpatient Sample. Int J Spine Surg. 2018 Oct 15;12(5):617-623. doi: 10.14444/5076. eCollection 2018 Oct.
PubMed 30364742Gan TJ. Poorly controlled postoperative pain: prevalence, consequences, and prevention. J Pain Res. 2017 Sep 25;10:2287-2298. doi: 10.2147/JPR.S144066. eCollection 2017.
PubMed 29026331Huang J, Liu JC. Ultrasound-guided erector spinae plane block for postoperative analgesia: a meta-analysis of randomized controlled trials. BMC Anesthesiol. 2020 Apr 14;20(1):83. doi: 10.1186/s12871-020-00999-8.
PubMed 32290814Abdelbadie M. Analgesic efficacy of the erector spinae plane block using bupivacaine vs. bupivacaine/magnesium sulphate in patients undergoing lumbar spine surgery: a randomized, double-blinded comparative study. Anaesthesia, Pain & Intensive Care. 2022;26(4):439-44.
Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
PubMed 27501016Qiu Y, Zhang TJ, Hua Z. Erector Spinae Plane Block for Lumbar Spinal Surgery: A Systematic Review. J Pain Res. 2020 Jul 1;13:1611-1619. doi: 10.2147/JPR.S256205. eCollection 2020.
PubMed 32669870Coviello A, Vargas M, Castellano G, Maresca A, Servillo G. Ultrasound-guided Erector Spinae Plane Block (US-ESPB)-Anesthetic block: Case report. Clin Case Rep. 2020 Sep 10;8(12):2885-2888. doi: 10.1002/ccr3.3253. eCollection 2020 Dec.
PubMed 33363844Stondell C, Roberto R. Erector Spinae Plane Blocks With Liposomal Bupivacaine for Pediatric Scoliosis Surgery. J Am Acad Orthop Surg Glob Res Rev. 2022 Jan 21;6(1):e21.00272. doi: 10.5435/JAAOSGlobal-D-21-00272.
PubMed 35061632Bhushan S, Huang X, Su X, Luo L, Xiao Z. Ultrasound-guided erector spinae plane block for postoperative analgesia in patients after liver surgery: A systematic review and meta-analysis on randomized comparative studies. Int J Surg. 2022 Jul;103:106689. doi: 10.1016/j.ijsu.2022.106689. Epub 2022 Jun 1.
PubMed 35662584Schnabel A, Reichl SU, Weibel S, Kranke P, Zahn PK, Pogatzki-Zahn EM, Meyer-Friessem CH. Efficacy and safety of dexmedetomidine in peripheral nerve blocks: A meta-analysis and trial sequential analysis. Eur J Anaesthesiol. 2018 Oct;35(10):745-758. doi: 10.1097/EJA.0000000000000870.
PubMed 30095549
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Adding Dexmedetomidine to Bupivacaine for Bilateral Erector Spinae Block in Lumbar Fusion Surgeries
- ClinicalTrials.gov ID
- NCT06231979
- Acronym / sponsor ID
- Erector Spinae Block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 25 Feb 2024 (estimated)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 30 Jan 2024 (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.
The aim of this study is to compare the analgesic effect of bilateral US-guided ESPB using bupivacaine alone versus bupivacaine and DEX in lumbar fusion surgeries.
Detailed description
Surgical treatment of adult lumbar spinal disorders is associated with a substantial risk of perioperative complications. The improvement in management and the development of new techniques in anesthesia and surgical sciences have led to substantial reduction of complications related to lumbar spine surgeries.
Understanding these complications is important and valuable for both the patient and the surgeon. Nevertheless, complications represent undesirable consequences of lumbar spine surgery in adult patients.
Degenerative lumbar disease is one of the most common chronic diseases worldwide. The general incidence of lumbar stenosis accompanied by a significant deterioration in the quality of life reaches 5 % among patients aged < 50 years and approximately 10 - 15 % among elderly patients (50 - 70 years old) Moreover, lumbar stenosis appears to be one of the most common causes of decompression and fusion interventions in the lumbar spine in > 50 years old patients Lumbar surgeries refer to any type of surgical intervention involving any lumbar spine or lower back (between one or more of the L1 - S1 level), including operations for trauma and deformity. The complexity of procedures leads to an increase in comorbidities Major lumbar spine surgery causes severe postoperative pain, which typically persists for at least three days Risk factors most frequently associated with mortality include but are not limited to patients' age, sex, and comorbidity status Postoperative pain is one of the most troublesome pains for the surgical patients and is one of the causes of morbidity and prolonged hospital stay. Various studies have reported that maximal pain occurs in the first 4 postoperative hours and gradually declines by the third postoperative day .
Opiates and non-steroidal anti-inflammatory drugs have been routinely used across the world. Recent resurge of regional anesthetic techniques offer some advantages, especially reduced postoperative nausea and vomiting and less sedation .
Ultrasound (US)-guided erector spinae plane blockade (ESPB) was first developed by Forero in 2016 as an easy and safe way of managing thoracic neuropathic pain. Since that time, this block has gained in popularity and has been used to effectively provide analgesia for a variety of surgeries, including spine surgery .
Erector spinae plane blockade may also have a better safety profile when compared with neuraxial analgesia, perhaps because of direct visualization of the needle under ultrasonography guidance and the ease of placement, although this has not been decisively proven One disadvantage of this block is the short duration of action after a single injection Dexmedetomidine (DEX), is a highly selective and potent central alpha-2 adrenergic receptor agonist. Administration of this adjuvant in miscellaneous methods has received considerable attention in recent years Due to its analgesic and sedative effects, besides the lack of any respiratory-sparing effects, administration of this adjuvant is effective in reducing the need for opioids in the perioperative period and may even result in cooperative sedation.
The neuraxial administration of dexmedetomidine has nociceptive effects on somatic and visceral pains. It also reduces postoperative pain and prolongs analgesia.
Local anesthetic combined with DEX has been reported to prolong analgesia following several blocks. However, it is presently unclear whether adjuncts such as DEX will significantly prolong the duration of ESPB in lumbar fusion surgery.
Oxidative stress is a condition caused by an imbalance between the production and accumulation of reactive oxygen species (ROS) and the body's ability to detoxify these products.
An excess of ROS causes damage to all cellular components. The process of oxidative stress causes the peroxidation of lipids and proteins, the formation of lipid peroxides, DNA fragmentation, and the development of cell death.
ROS activity is usually assessed indirectly by measuring stable products derived from the interaction of these radicals with cellular components. The most-studied cellular antioxidants are superoxide dismutase (SOD) , glutathione peroxidase 1 (GPX1) and human malondialdehyde (MDA).
These enzymes provide the first line of defense against tissue damage caused by ROS. As part of the antioxidant pathway, SOD accelerates the conversion of superoxide to H2O2, while catalase and GPX convert H2O2 to water. SOD and GPX can be measured in serum or plasma to establish the levels of oxidative stress and antioxidant capacity of the body.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine group | Experimental | Drug: Dexmedetomidine, Drug: BupivacainPatients will receive US-guided ESPB with 18 mL of bupivacaine 0.25 % and 1 μg/kg DEX diluted with saline to reach total volume 20 mL per side. |
| Bupivacaine group | Experimental | Drug: Bupivacain, Drug: Normal salinePatients will receive US-guided ESPB with 18 mL of bupivacaine 0.25 % and 2 mL normal saline 0.9 % per side as control group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients of both genders
- age between 18-65 years
- American Society of Anesthesiologists (ASA) physical status I-II**
- scheduled for lumbar spine fusion surgeries ( 2 or 3 level lumbar fusion with or without decompression ) under general anesthesia .
Key exclusion criteria (5 listed)
- Patient refusal.
- Patient with chronic use of opioid analgesia.
- Uncooperative patients with communication difficulties, which might prevent a reliable postoperative assessment.
- Contraindication to regional anesthesia (bleeding disorder, use of any anticoagulants, local infection).
- Known allergy to local anesthetics.
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 |
|---|---|---|
| DexmedetomidineAlso: DEX1 μg/kg Dexmedetomidine per side in erector spinae block | Drug | Dexmedetomidine group |
| BupivacainAlso: Bup18 mL of bupivacaine 0.25 % per side in erector spinae block | Drug | Bupivacaine group, Dexmedetomidine group |
| Normal salineAlso: Normal saline sodium chloride 0.9%2 ml normal saline 0.9% per side in erector spinae block | Drug | Bupivacaine group |
Primary outcome
the cummulative opioid consumption during first 48 h postoperatively.
Time frame: 48 hours postoperatively.
2 secondary outcomes
Change in stress marker Super Oxide Dismutase (SOD) .
Time frame: 24 hours postoperative.
Postoperative pain score using Visual Analogue Scale (VAS).
Time frame: immediately postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Background: PubMed 24078855Kalff R, Ewald C, Waschke A, Gobisch L, Hopf C. Degenerative lumbar spinal stenosis in older people: current treatment options. Dtsch Arztebl Int. 2013 Sep;110(37):613-23; quiz 624. doi: 10.3238/arztebl.2013.0613. Epub 2013 Sep 13.
- Background: PubMed 37452304Liu C, Guo C, Meng F, Zhu Z, Xia W, Liu H. Perioperative risk factors related to complications of lumbar spine fusion surgery in elderly patients. BMC Musculoskelet Disord. 2023 Jul 14;24(1):573. doi: 10.1186/s12891-023-06689-z.
- Background: PubMed 28435551Dhillon KS. Spinal Fusion for Chronic Low Back Pain: A 'Magic Bullet' or Wishful Thinking? Malays Orthop J. 2016 Mar;10(1):61-68.
- Background: PubMed 23960276Proietti L, Scaramuzzo L, Schiro' GR, Sessa S, Logroscino CA. Complications in lumbar spine surgery: A retrospective analysis. Indian J Orthop. 2013 Jul;47(4):340-5. doi: 10.4103/0019-5413.114909.
- BackgroundEl-Sadawy Ali Eid M, Ibrahim Mohamed Hashesh M and Ahmed El-Badawy Mohamed M. Comparative Study Between Bupivacaine Alone Versus Bupivacaine With Fentanyl, And Bupivacaine With Dexamethasone In Ultrasound Guided Erector Spinae Plane Block For Postoperative Pain Relief In Patients Undergoing Lumber Spine Surgeries. Al-Azhar Medical Journal. 2022;51(1):507-18.
- Background: PubMed 30364742Poorman GW, Moon JY, Wang C, Horn SR, Beaubrun BM, Bono OJ, Francis AM, Jalai CM, Passias PG. Rates of Mortality in Lumbar Spine Surgery and Factors Associated With Its Occurrence Over a 10-Year Period: A Study of 803,949 Patients in the Nationwide Inpatient Sample. Int J Spine Surg. 2018 Oct 15;12(5):617-623. doi: 10.14444/5076. eCollection 2018 Oct.
- Background: PubMed 29026331Gan TJ. Poorly controlled postoperative pain: prevalence, consequences, and prevention. J Pain Res. 2017 Sep 25;10:2287-2298. doi: 10.2147/JPR.S144066. eCollection 2017.
- Background: PubMed 32290814Huang J, Liu JC. Ultrasound-guided erector spinae plane block for postoperative analgesia: a meta-analysis of randomized controlled trials. BMC Anesthesiol. 2020 Apr 14;20(1):83. doi: 10.1186/s12871-020-00999-8.
- BackgroundAbdelbadie M. Analgesic efficacy of the erector spinae plane block using bupivacaine vs. bupivacaine/magnesium sulphate in patients undergoing lumbar spine surgery: a randomized, double-blinded comparative study. Anaesthesia, Pain & Intensive Care. 2022;26(4):439-44.
- Background: PubMed 27501016Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
- Background: PubMed 32669870Qiu Y, Zhang TJ, Hua Z. Erector Spinae Plane Block for Lumbar Spinal Surgery: A Systematic Review. J Pain Res. 2020 Jul 1;13:1611-1619. doi: 10.2147/JPR.S256205. eCollection 2020.
- Background: PubMed 33363844Coviello A, Vargas M, Castellano G, Maresca A, Servillo G. Ultrasound-guided Erector Spinae Plane Block (US-ESPB)-Anesthetic block: Case report. Clin Case Rep. 2020 Sep 10;8(12):2885-2888. doi: 10.1002/ccr3.3253. eCollection 2020 Dec.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine, Bupivacain and Normal saline in people with Erector Spinae Block and Lumbar Fusion Surgeries, run by Assiut University.
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 5 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 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
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?
the cummulative opioid consumption during first 48 h postoperatively. (time frame: 48 hours postoperatively.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06231979, which also lists 22 linked publications.
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 Jan 2024.