Spine FusionNCT06970704
Erector Spinae Plane Block in Spine Surgeries for Postoperative Pain
A study testing Erector Spinae Plane Block using 0.25 % bupivacaine in people with Spine Fusion and Spine Metastases, run by Ain Shams University at 1 site in Egypt.
Trial summary
This prospective single-blind randomized controlled study on 50 patients between 18 and 65 years, both sexes, with ASA I-II and undergoing elective lumbar spine surgical procedures. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spine Fusion, Spine Metastases, Postoperative Pain
- What is being tested?
- Erector Spinae Plane Block using 0.25 % bupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 31 Dec 2023to 30 Jun 2024
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged from 18 and 65 years, both sexes
- The American Society of Anesthesiology (ASA) physical status I-II
- Scheduled for elective lumbar spine surgical procedures
Who cannot join
- Coagulation disorders
- BMI > 30 or < 18 kg/m2
- Patients with surgical site infection
- Known sensitivity or contraindication to local anesthetics
- History of psychological disorders
- Patients with unstable spine integrity like fractures or scoliosis
- Hypertensive, cardiac, and diabetic patients,
- Known alcohol or substance abuse within the last 6 months and Daily opioid intake
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Erector Spinae Plane Block Combined With General Anesthesia Versus General Anesthesia Alone in Spine Surgeries for Postoperative Pain, A Randomized Controlled Trial
This prospective single-blind randomized controlled study on 50 patients between 18 and 65 years, both sexes, with ASA I-II and undergoing elective lumbar spine surgical procedures. They were equally divided into two groups: Group Erector Spinae Plane Block (ESPB) (Study): (number = 25) received Erector Spinae Plane Block (20 ml bupivacaine 0.25%) combined with general anesthesia. Group General Anesthesia (GA) (Control): (number = 25) received conventional general anesthesia.
Read the detailed description
In both groups, on arrival to the operation room, a multi-channel monitor will be attached to the patient to display continuous electrocardiogram (ECG) monitoring, heart rate (HR), non-invasive blood pressure, pulse oximeter, temperature probe, capnogram, and anesthetic gas analysis. An intravenous line will be secured, then lactated Ringer's solution will be started at 5 ml/kg/h. Ten minutes before induction of anesthesia, all patients will be premedicated with intravenous midazolam 0.02 mg/kg. Patients will be preoxygenated with 100% oxygen for 3 minutes. In both groups, induction of anesthesia will be carried out by intravenous administration of fentanyl 1 µg/kg, lidocaine 1.5 mg/kg, and propofol 2 mg/kg. After loss of verbal communication, 0.5 mg/kg atracurium will be administered. Intermittent positive pressure ventilation will be adjusted to maintain an end-tidal carbon dioxide partial pressure between 30 and 35 mmHg. Anesthesia will be maintained with 1-2% isoflurane, 0.1 mg/kg atracurium bolus doses will be administered every 20 minutes, and 0.5 µg/kg fentanyl will be administered every 30 minutes.
In the Erector Spinae Plane block (ESPB) group, after prone positioning and before surgery, Erector Spinae Plane Block will be performed bilaterally using a low-frequency curved ultrasound transducer placed in a longitudinal orientation 3 cm lateral to the spinous process one vertebral level above a predetermined marked surgical incision. An 8-cm 22-gauge block needle will be inserted in a cephalad to caudad direction until the tip lies in the interfascial plane below the erector spinae muscle; the block will be performed by injection of 20 ml of 0.25% bupivacaine. In both groups, fentanyl 1 µg/kg as rescue analgesia will be given based on hemodynamic parameters.
If the mean arterial blood pressure (MAP) has fallen below 65 mmHg, 5 mg of ephedrine will be administered, and an intravenous bolus of 0.5 mg of atropine will be administered in case of bradycardia if the heart rate ≤50 bpm. The blood pressure will return to the baseline value before surgical field closure. Then at the end of surgery, the isoflurane vaporizer will be turned off, and the muscle relaxant will be reversed with neostigmine 0.04 mg/kg and atropine 0.02 mg/kg. The endotracheal tube will be removed after the patient regains consciousness and full muscle power, breathes spontaneously, and responds to verbal commands. Isoflurane consumption was measured at the end of surgery.
Postoperative pain management:
A standardized analgesic regimen will be prescribed in the postoperative period. All patients will receive 1 gm of paracetamol every 6 h. If the numeric rating scale (NRS) is more than 3, intravenous morphine 3mg will be administered by an investigator blinded to group assignment.
Clinical evaluation:
Total intravenous drug administration at the post-anesthesia care unit (PACU) and over the 48 hours was recorded. Opioid-related adverse events arising from the analgesic protocol will be systematically assessed at the PACU and surgical ward. The presence of nausea, vomiting, respiratory depression, pruritus, urinary retention requiring evacuation, allergy, and hallucinations will be recorded as binary (yes/no). Arterial oxygen saturation (pulse oximetry), heart and respiratory rates, and blood pressure will also be recorded every 6 hours.
The Ramsay Sedation Scale will be assessed postoperatively. The Ramsay sedation scale comprises two clearly defined groups of scores: those of 1, 2, and 3 are given in assessing degrees of wakefulness, and those of 4, 5, and 6 are given in assessing degrees of sleep. The six levels of the Ramsay sedation scale allow for visual assessments of sedation in patients who are responsive to such assessments
- Conditions
- Spine Fusion, Spine Metastases, Postoperative Pain
- Being tested
- Erector Spinae Plane Block using 0.25 % bupivacaine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector Spinae Plane Block using 0.25 % bupivacaineOther
After induction of anesthesia and prone positioning and before surgery, Erector Spinae Plane Block was performed bilaterally using a low-frequency curved ultrasound transducer placed in a longitudinal orientation 3 cm lateral to the spinous process one vertebral level above a predetermined marked surgical incision. An 8-cm 22-gauge block needle was inserted in a cephalad to caudad direction until the tip lay in the interfascial plane below the erector spinae muscle, the block was performed by injection of 20 ml of 0.25% bupivacaine. Fentanyl 1 µg/kg as a rescue analgesia was given based on hemodynamic parameters.
| Study group | Role | What they receive |
|---|---|---|
| Group Erector Spinae Plane Block (ESPB) (Study) | Active comparator | Patients in this group will receive Erector Spinae Plane Block (20 ml bupivacaine 0.25%) combined with general anesthesia Receives: Other: Erector Spinae Plane Block using 0.25 % bupivacaine |
| Group General Anesthesia (GA) (Control) | Active comparator | Patients in this group will receive conventional general anesthesia Receives: Other: Erector Spinae Plane Block using 0.25 % bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain severity
Using Pain Numeric Rating Scale Scores
Measured: Postoperatively Day 1
Time to the first postoperative rescue analgesic
Time to first use of morphine
Measured: Postoperatively Day 1
Fentanyl consumption.
Intraoperative fentanyl consumption
Measured: During Intraoperative period
Isoflurane consumption.
Intraoperative fentanyl and isoflurane consumption.
Measured: During Intraoperative period
Secondary outcomes (3)
Changes in mean arterial pressure
Perioperative changes in mean arterial pressure
Measured: Immediately before the operation till Postoperatively Day 1
Changes in heart rate
Perioperative changes in heart rate
Measured: Immediately before the operation till Postoperatively Day 1
Postoperative nausea and vomiting
Number of postoperative nausea and vomiting episodes
Measured: Postoperatively Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start31 Dec 2023
- Primary completion31 May 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Spine FusionStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06970704
- Sponsor's protocol ID
- FMASU MS 681/2023
- Status last verified
- Sep 2024
- First submitted
- 1 Oct 2024
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Prabhakar NK, Chadwick AL, Nwaneshiudu C, Aggarwal A, Salmasi V, Lii TR, Hah JM. Management of Postoperative Pain in Patients Following Spine Surgery: A Narrative Review. Int J Gen Med. 2022 May 2;15:4535-4549. doi: 10.2147/IJGM.S292698. eCollection 2022.
PubMed 35528286Ye Y, Bi Y, Ma J, Liu B. Thoracolumbar interfascial plane block for postoperative analgesia in spine surgery: A systematic review and meta-analysis. PLoS One. 2021 May 21;16(5):e0251980. doi: 10.1371/journal.pone.0251980. eCollection 2021.
PubMed 34019598Hyland SJ, Brockhaus KK, Vincent WR, Spence NZ, Lucki MM, Howkins MJ, Cleary RK. Perioperative Pain Management and Opioid Stewardship: A Practical Guide. Healthcare (Basel). 2021 Mar 16;9(3):333. doi: 10.3390/healthcare9030333.
PubMed 33809571Jin Y, Zhao S, Cai J, Blessing M, Zhao X, Tan H, Li J. Erector Spinae Plane Block for Perioperative Pain Control and Short-term Outcomes in Lumbar Laminoplasty: A Randomized Clinical Trial. J Pain Res. 2021 Sep 3;14:2717-2727. doi: 10.2147/JPR.S321514. eCollection 2021.
PubMed 34512011Rasheed AM, Amirah MF, Abdallah M, P J P, Issa M, Alharthy A. Ramsay Sedation Scale and Richmond Agitation Sedation Scale: A Cross-sectional Study. Dimens Crit Care Nurs. 2019 Mar/Apr;38(2):90-95. doi: 10.1097/DCC.0000000000000346.
PubMed 30702478Nashibi M, Sezari P, Safari F, Teymourian H, Asgari S, Mottaghi K. The effect of erector spinae plane block on the use of anesthetic medications in lumbar spine surgery. Agri. 2023 Oct;35(4):228-235. doi: 10.14744/agri.2022.48992.
PubMed 37886866Elewa AM, Faisal M, Sjoberg F, Abuelnaga ME. Comparison between erector spinae plane block and paravertebral block regarding postoperative analgesic consumption following breast surgery: a randomized controlled study. BMC Anesthesiol. 2022 Jun 18;22(1):189. doi: 10.1186/s12871-022-01724-3.
PubMed 35717148Zhang Q, Wu Y, Ren F, Zhang X, Feng Y. Bilateral ultrasound-guided erector spinae plane block in patients undergoing lumbar spinal fusion: A randomized controlled trial. J Clin Anesth. 2021 Feb;68:110090. doi: 10.1016/j.jclinane.2020.110090. Epub 2020 Oct 20.
PubMed 33096517
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erector Spinae Plane Block Combined With General Anesthesia Versus General Anesthesia Alone in Spine Surgeries for Postoperative Pain, A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06970704
- Acronym / sponsor ID
- FMASU MS 681/2023
- Conditions
- Spine Fusion, Spine Metastases, Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 31 Dec 2023 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 14 May 2025 (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.
This prospective single-blind randomized controlled study on 50 patients between 18 and 65 years, both sexes, with ASA I-II and undergoing elective lumbar spine surgical procedures. They were equally divided into two groups: Group Erector Spinae Plane Block (ESPB) (Study): (number = 25) received Erector Spinae Plane Block (20 ml bupivacaine 0.25%) combined with general anesthesia. Group General Anesthesia (GA) (Control): (number = 25) received conventional general anesthesia.
Detailed description
In both groups, on arrival to the operation room, a multi-channel monitor will be attached to the patient to display continuous electrocardiogram (ECG) monitoring, heart rate (HR), non-invasive blood pressure, pulse oximeter, temperature probe, capnogram, and anesthetic gas analysis. An intravenous line will be secured, then lactated Ringer's solution will be started at 5 ml/kg/h. Ten minutes before induction of anesthesia, all patients will be premedicated with intravenous midazolam 0.02 mg/kg. Patients will be preoxygenated with 100% oxygen for 3 minutes. In both groups, induction of anesthesia will be carried out by intravenous administration of fentanyl 1 µg/kg, lidocaine 1.5 mg/kg, and propofol 2 mg/kg. After loss of verbal communication, 0.5 mg/kg atracurium will be administered. Intermittent positive pressure ventilation will be adjusted to maintain an end-tidal carbon dioxide partial pressure between 30 and 35 mmHg. Anesthesia will be maintained with 1-2% isoflurane, 0.1 mg/kg atracurium bolus doses will be administered every 20 minutes, and 0.5 µg/kg fentanyl will be administered every 30 minutes.
In the Erector Spinae Plane block (ESPB) group, after prone positioning and before surgery, Erector Spinae Plane Block will be performed bilaterally using a low-frequency curved ultrasound transducer placed in a longitudinal orientation 3 cm lateral to the spinous process one vertebral level above a predetermined marked surgical incision. An 8-cm 22-gauge block needle will be inserted in a cephalad to caudad direction until the tip lies in the interfascial plane below the erector spinae muscle; the block will be performed by injection of 20 ml of 0.25% bupivacaine. In both groups, fentanyl 1 µg/kg as rescue analgesia will be given based on hemodynamic parameters.
If the mean arterial blood pressure (MAP) has fallen below 65 mmHg, 5 mg of ephedrine will be administered, and an intravenous bolus of 0.5 mg of atropine will be administered in case of bradycardia if the heart rate ≤50 bpm. The blood pressure will return to the baseline value before surgical field closure. Then at the end of surgery, the isoflurane vaporizer will be turned off, and the muscle relaxant will be reversed with neostigmine 0.04 mg/kg and atropine 0.02 mg/kg. The endotracheal tube will be removed after the patient regains consciousness and full muscle power, breathes spontaneously, and responds to verbal commands. Isoflurane consumption was measured at the end of surgery.
Postoperative pain management:
A standardized analgesic regimen will be prescribed in the postoperative period. All patients will receive 1 gm of paracetamol every 6 h. If the numeric rating scale (NRS) is more than 3, intravenous morphine 3mg will be administered by an investigator blinded to group assignment.
Clinical evaluation:
Total intravenous drug administration at the post-anesthesia care unit (PACU) and over the 48 hours was recorded. Opioid-related adverse events arising from the analgesic protocol will be systematically assessed at the PACU and surgical ward. The presence of nausea, vomiting, respiratory depression, pruritus, urinary retention requiring evacuation, allergy, and hallucinations will be recorded as binary (yes/no). Arterial oxygen saturation (pulse oximetry), heart and respiratory rates, and blood pressure will also be recorded every 6 hours.
The Ramsay Sedation Scale will be assessed postoperatively. The Ramsay sedation scale comprises two clearly defined groups of scores: those of 1, 2, and 3 are given in assessing degrees of wakefulness, and those of 4, 5, and 6 are given in assessing degrees of sleep. The six levels of the Ramsay sedation scale allow for visual assessments of sedation in patients who are responsive to such assessments
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 |
|---|---|---|
| Group Erector Spinae Plane Block (ESPB) (Study) | Active comparator | Other: Erector Spinae Plane Block using 0.25 % bupivacainePatients in this group will receive Erector Spinae Plane Block (20 ml bupivacaine 0.25%) combined with general anesthesia |
| Group General Anesthesia (GA) (Control) | Active comparator | Other: Erector Spinae Plane Block using 0.25 % bupivacainePatients in this group will receive conventional general anesthesia |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged from 18 and 65 years, both sexes
- The American Society of Anesthesiology (ASA) physical status I-II
- Scheduled for elective lumbar spine surgical procedures
Key exclusion criteria (8 listed)
- Coagulation disorders
- BMI > 30 or < 18 kg/m2
- Patients with surgical site infection
- Known sensitivity or contraindication to local anesthetics
- History of psychological disorders
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 |
|---|---|---|
| Erector Spinae Plane Block using 0.25 % bupivacaineAfter induction of anesthesia and prone positioning and before surgery, Erector Spinae Plane Block was performed bilaterally using a low-frequency curved ultrasound transducer placed in a longitudinal orientation 3 cm lateral to the spinous process one vertebral level above a predetermined marked surgical incision. An 8-cm 22-gauge block needle was inserted in a cephalad to caudad direction until the tip lay in the interfascial plane below the erector spinae muscle, the block was performed by injection of 20 ml of 0.25% bupivacaine. Fentanyl 1 µg/kg as a rescue analgesia was given based on hemodynamic parameters. | Other | Group Erector Spinae Plane Block (ESPB) (Study), Group General Anesthesia (GA) (Control) |
Primary outcome
Postoperative pain severity
Time frame: Postoperatively Day 1
Using Pain Numeric Rating Scale Scores
Time to the first postoperative rescue analgesic
Time frame: Postoperatively Day 1
Time to first use of morphine
Fentanyl consumption.
Time frame: During Intraoperative period
Intraoperative fentanyl consumption
Isoflurane consumption.
Time frame: During Intraoperative period
Intraoperative fentanyl and isoflurane consumption.
3 secondary outcomes
Changes in mean arterial pressure
Time frame: Immediately before the operation till Postoperatively Day 1
Changes in heart rate
Time frame: Immediately before the operation till Postoperatively Day 1
Postoperative nausea and vomiting
Time frame: Postoperatively Day 1
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 22 May 2025.
- Background: PubMed 35528286Prabhakar NK, Chadwick AL, Nwaneshiudu C, Aggarwal A, Salmasi V, Lii TR, Hah JM. Management of Postoperative Pain in Patients Following Spine Surgery: A Narrative Review. Int J Gen Med. 2022 May 2;15:4535-4549. doi: 10.2147/IJGM.S292698. eCollection 2022.
- Background: PubMed 34019598Ye Y, Bi Y, Ma J, Liu B. Thoracolumbar interfascial plane block for postoperative analgesia in spine surgery: A systematic review and meta-analysis. PLoS One. 2021 May 21;16(5):e0251980. doi: 10.1371/journal.pone.0251980. eCollection 2021.
- Background: PubMed 33809571Hyland SJ, Brockhaus KK, Vincent WR, Spence NZ, Lucki MM, Howkins MJ, Cleary RK. Perioperative Pain Management and Opioid Stewardship: A Practical Guide. Healthcare (Basel). 2021 Mar 16;9(3):333. doi: 10.3390/healthcare9030333.
- Background: PubMed 34512011Jin Y, Zhao S, Cai J, Blessing M, Zhao X, Tan H, Li J. Erector Spinae Plane Block for Perioperative Pain Control and Short-term Outcomes in Lumbar Laminoplasty: A Randomized Clinical Trial. J Pain Res. 2021 Sep 3;14:2717-2727. doi: 10.2147/JPR.S321514. eCollection 2021.
- Background: PubMed 30702478Rasheed AM, Amirah MF, Abdallah M, P J P, Issa M, Alharthy A. Ramsay Sedation Scale and Richmond Agitation Sedation Scale: A Cross-sectional Study. Dimens Crit Care Nurs. 2019 Mar/Apr;38(2):90-95. doi: 10.1097/DCC.0000000000000346.
- Background: PubMed 37886866Nashibi M, Sezari P, Safari F, Teymourian H, Asgari S, Mottaghi K. The effect of erector spinae plane block on the use of anesthetic medications in lumbar spine surgery. Agri. 2023 Oct;35(4):228-235. doi: 10.14744/agri.2022.48992.
- Background: PubMed 35717148Elewa AM, Faisal M, Sjoberg F, Abuelnaga ME. Comparison between erector spinae plane block and paravertebral block regarding postoperative analgesic consumption following breast surgery: a randomized controlled study. BMC Anesthesiol. 2022 Jun 18;22(1):189. doi: 10.1186/s12871-022-01724-3.
- Background: PubMed 33096517Zhang Q, Wu Y, Ren F, Zhang X, Feng Y. Bilateral ultrasound-guided erector spinae plane block in patients undergoing lumbar spinal fusion: A randomized controlled trial. J Clin Anesth. 2021 Feb;68:110090. doi: 10.1016/j.jclinane.2020.110090. Epub 2020 Oct 20.
- Individual participant dataSharing planned: Yes
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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 study testing Erector Spinae Plane Block using 0.25 % bupivacaine in people with Spine Fusion and Spine Metastases, 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 3 inclusion and 8 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 22 May 2025. 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?
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?
Postoperative pain severity (time frame: Postoperatively Day 1). The study lists 4 primary outcomes in all. 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 NCT06970704, which also lists 8 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 22 May 2025.