Pain, PostoperativeNCT04749095
Erector Spinae Plane Block Analgesia for Lumbar Spine Fusion Surgery
A study testing Erector spinae plane block in people with Pain, Postoperative, run by Benha University.
Trial summary
The purpose of this study was to investigate the effect of a bilateral ultrasound guided erector spinae plane block on the pain scores and opoid utiliziation in fusion surgery of the lumbar spine. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Erector spinae plane block
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- May 2021to Sep 2021
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists class I-III adult patients
- BMI less than or equal 35 kg/m2
Who cannot join
- Patient refusal
- unable to give consent
- age < 18 or > 65
- BMI more than 35 kg/m2
- known allergy to the study medication
- coagulopathies or on anticoagulant medications
Show all 9Show fewer
- hepatic insufficiency
- renal insufficiency
- chronic opioid use
About this study
Official title: Can Bilateral Erector Spinae Plane Block Minimize Perioprative Opioid Consumption and Provide Satisfactory Analgesia for Lumbar Spine Fusion Surgery? A Randomized Controlled Study
The purpose of this study was to investigate the effect of a bilateral ultrasound guided erector spinae plane block on the pain scores and opoid utiliziation in fusion surgery of the lumbar spine.
- Conditions
- Pain, Postoperative
- Being tested
- Erector spinae plane block, sham subcutaneous infiltration
- 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 blockDrug
bilateral ESP block will be injected with 20 ml of 0.25% bupivacaine
sham subcutaneous infiltrationDrug
bilateral ESP block will be injected with 20 ml of normal saline
| Study group | Role | What they receive |
|---|---|---|
| Erector block | Active comparator | Not described Receives: Drug: Erector spinae plane block |
| sham block | Active comparator | Not described Receives: Drug: sham subcutaneous infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analgesia
Numerical rating scale of pain every 6 hours
Measured: Up to 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2021
- Study startMay 2021 (estimated)
- Primary completionAug 2021 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Benha 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Baher Said Elshahat Mohamed Abdelhady, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04749095
- Sponsor's protocol ID
- erector spinae plane block
- Status last verified
- Feb 2021
- First submitted
- 5 Feb 2021
- Last updated
- 11 Feb 2021
- 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 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Bilateral Erector Spinae Plane Block Minimize Perioprative Opioid Consumption and Provide Satisfactory Analgesia for Lumbar Spine Fusion Surgery? A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04749095
- Acronym / sponsor ID
- erector spinae plane block
- Conditions
- Pain, Postoperative
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- May 2021 (estimated)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 11 Feb 2021 (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 purpose of this study was to investigate the effect of a bilateral ultrasound guided erector spinae plane block on the pain scores and opoid utiliziation in fusion surgery of the lumbar spine.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erector block | Active comparator | Drug: Erector spinae plane block |
| sham block | Active comparator | Drug: sham subcutaneous infiltration |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists class I-III adult patients
- BMI less than or equal 35 kg/m2
Key exclusion criteria (9 listed)
- Patient refusal
- unable to give consent
- age < 18 or > 65
- BMI more than 35 kg/m2
- known allergy to the study medication
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 blockbilateral ESP block will be injected with 20 ml of 0.25% bupivacaine | Drug | Erector block |
| sham subcutaneous infiltrationbilateral ESP block will be injected with 20 ml of normal saline | Drug | sham block |
Primary outcome
Analgesia
Time frame: Up to 24 hours after surgery
Numerical rating scale of pain every 6 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2021.
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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 study testing Erector spinae plane block in people with Pain, Postoperative, run by Benha 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 2 inclusion and 9 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 11 Feb 2021. 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.
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?
Analgesia (time frame: Up to 24 hours after surgery). 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 11 Feb 2021; AzTrials last refreshed its copy on 8 Nov 2026.