AnalgesiaPhase 4NCT05892887
Analgesic Efficacy of Different Volumes in Erector Spinae Plane Block in Single Level Lumbar Spine Fixation
A Phase 4 study testing Bupivacaine 0.25% Injectable Solution in people with Analgesia, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
The analgesic efficacy of different volumes in ESPB patients undergoing single-level lumbar spine fixation 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 0.25% Injectable Solution
- 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
- 1 Jun 2023to 20 Sep 2023
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-65 years.
- Both genders.
- American Society of Anesthesiologists' (ASA) physical status I or II.
- Undergoing single level lumbar spine fixation.
Who cannot join
- Patient refusal.
- Pregnant females.
- Renal, lung, heart, or liver disorders.
- 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).
- BMI more than 30 kg/m2.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analgesic Efficacy of Different Volumes in Erector Spinae Plane Block in Patients Undergoing Single Level Lumbar Spine Fixation: A Non-inferiority Randomized Clinical Trial
The analgesic efficacy of different volumes in ESPB patients undergoing single-level lumbar spine fixation
Read the detailed description
The erector spinae plane block (ESPB) its an interfacial plane block for an effective treatment for thoracic neuropathic pain. Currently, compared to the use of opioids, the ESPB has fewer side effects and is safe for patients of all ages having abdominal and thoracic operations .
- Conditions
- Analgesia
- Being tested
- Bupivacaine 0.25% Injectable Solution
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine 0.25% Injectable SolutionDrug
Bilateral ultrasound guided in erector spinae plane block by bupivacaine 0.25%
| Study group | Role | What they receive |
|---|---|---|
| Erector 10 | Experimental | Received 10ml of preoperative bilateral ultrasound guided ESPB by bupivacaine 0.25% on each side Receives: Drug: Bupivacaine 0.25% Injectable Solution |
| Erector 15 | Experimental | Received 15ml of preoperative bilateral ultrasound guided ESPB by bupivacaine 0.25% on each side Receives: Drug: Bupivacaine 0.25% Injectable Solution |
| Erector 20 | Experimental | Received 20ml of preoperative bilateral ultrasound guided ESPB by bupivacaine 0.25% on each side Receives: Drug: Bupivacaine 0.25% Injectable Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total morphine consumption
Patients were allowed to receive incremental doses of morphine 3mg intravenously if numerical rating scale pain score will be ≥ then the total amount of morphine will be recorded
Measured: First 24 hours postoperatively
Secondary outcomes (4)
Numerical rating scale
Postoperative pain using numerical rating scale (NRS) will be measured at post-anesthesia care unit, from 0 to 10, with 0 representing no pain and 10 representing maximum intolerable pain
Measured: Up to 48 hours postoperatively
Time to the first rescue analgesic
If numerical rating scale >4 was observed, rescue analgesia (morphine 3 mg IV) was administered
Measured: Up to 24 hours postoperatively
Postoperative complications
postoperative nausea and vomiting (PONV), hypotension (mean arterial pressure < 20% of baseline readings and was managed by ephedrine 5 mg IV and/or normal saline IVI), bradycardia (heart rate < 60 beats/min and was managed by atropine 0.6 mg IV).
Measured: Up to 24 hours postoperatively
5-point scale
The degree of patient satisfaction was assessed on a 5-point scale: (0= extremely dissatisfied, 1= unsatisfied, 2= neither satisfied nor unsatisfied, 3= satisfied), and 4= extremely satisfied).
Measured: Up to 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2023
- Study start1 Jun 2023
- Primary completion20 Sep 2023
- Study completion20 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Fouad Algyar, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05892887
- Sponsor's protocol ID
- MKSU 50- 1 - 10
- Status last verified
- Oct 2023
- First submitted
- 10 May 2023
- Last updated
- 10 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Publications
Algyar MF, Zahra AA, Elshikhali AS, Abdelhameed EA, El Hefny DA, Moharam SA, ElSharkawy MS, Farghaly OS, Ahmed MA. Analgesic efficacy of different volumes in erector spinae plane block in patients undergoing single level lumbar spine fixation: a non-inferiority randomized trial. BMC Anesthesiol. 2025 Sep 1;25(1):439. doi: 10.1186/s12871-025-03247-z.
PubMed 40890575
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of Different Volumes in Erector Spinae Plane Block in Patients Undergoing Single Level Lumbar Spine Fixation: A Non-inferiority Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05892887
- Acronym / sponsor ID
- MKSU 50- 1 - 10
- Conditions
- Analgesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 20 Sep 2023 (actual)
- Study completion
- 20 Sep 2023 (actual)
- First posted
- 7 Jun 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.
The analgesic efficacy of different volumes in ESPB patients undergoing single-level lumbar spine fixation
Detailed description
The erector spinae plane block (ESPB) its an interfacial plane block for an effective treatment for thoracic neuropathic pain. Currently, compared to the use of opioids, the ESPB has fewer side effects and is safe for patients of all ages having abdominal and thoracic operations .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Erector 10 | Experimental | Drug: Bupivacaine 0.25% Injectable SolutionReceived 10ml of preoperative bilateral ultrasound guided ESPB by bupivacaine 0.25% on each side |
| Erector 15 | Experimental | Drug: Bupivacaine 0.25% Injectable SolutionReceived 15ml of preoperative bilateral ultrasound guided ESPB by bupivacaine 0.25% on each side |
| Erector 20 | Experimental | Drug: Bupivacaine 0.25% Injectable SolutionReceived 20ml of preoperative bilateral ultrasound guided ESPB by bupivacaine 0.25% on each side |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18-65 years.
- Both genders.
- American Society of Anesthesiologists' (ASA) physical status I or II.
- Undergoing single level lumbar spine fixation.
Key exclusion criteria (6 listed)
- Patient refusal.
- Pregnant females.
- Renal, lung, heart, or liver disorders.
- 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 |
|---|---|---|
| Bupivacaine 0.25% Injectable SolutionBilateral ultrasound guided in erector spinae plane block by bupivacaine 0.25% | Drug | Erector 10, Erector 15, Erector 20 |
Primary outcome
Total morphine consumption
Time frame: First 24 hours postoperatively
Patients were allowed to receive incremental doses of morphine 3mg intravenously if numerical rating scale pain score will be ≥ then the total amount of morphine will be recorded
4 secondary outcomes
Numerical rating scale
Time frame: Up to 48 hours postoperatively
Time to the first rescue analgesic
Time frame: Up to 24 hours postoperatively
Postoperative complications
Time frame: Up to 24 hours postoperatively
5-point scale
Time frame: Up to 24 hours postoperative
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 10 Oct 2023.
- Derived from this study: PubMed 40890575Algyar MF, Zahra AA, Elshikhali AS, Abdelhameed EA, El Hefny DA, Moharam SA, ElSharkawy MS, Farghaly OS, Ahmed MA. Analgesic efficacy of different volumes in erector spinae plane block in patients undergoing single level lumbar spine fixation: a non-inferiority randomized trial. BMC Anesthesiol. 2025 Sep 1;25(1):439. doi: 10.1186/s12871-025-03247-z.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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 4 study testing Bupivacaine 0.25% Injectable Solution in people with Analgesia, run by Kafrelsheikh 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 6 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 10 Oct 2023. 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 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?
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?
Total 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?
On the ClinicalTrials.gov record for NCT05892887, which also lists 1 linked publication.
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 10 Oct 2023.