Fracture; Rib, MultipleNCT03853330
Erector Spinae Plane Block Versus Thoracic Epidural Analgesia in Patients With Multiple Fracture Ribs
A study testing Ultrasound, Bupivacaine HCl Inj 0.25% and Bupivacaine Hydrochloride, 0.125%-0.9% Injectable Solution in people with Fracture; Rib, Multiple, run by Assiut University at 1 site in Egypt.
Trial summary
To assess the analgesic and respiratory effect of continuous Erector Spinae Plane block versus Thoracic Epidural in patients with multiple fracture ribs. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Fracture; Rib, Multiple
- What is being tested?
- Ultrasound, Bupivacaine HCl Inj 0.25% and Bupivacaine Hydrochloride, 0.125%-0.9% Injectable Solution
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2019to 30 Dec 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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with multiple fracture ribs.
Who cannot join
- Patient refusal.
- Patients with pre-existing infection at the block site.
- Coagulopathy.
- Allergy to local anesthetics.
- Pre-existing neurological deficits.
- Psychiatric illness.
Trial locations and contacts
1 site in 1 country.
About this study
To assess the analgesic and respiratory effect of continuous Erector Spinae Plane block versus Thoracic Epidural in patients with multiple fracture ribs.
Read the detailed description
Erector spinae plane (ESP) block is a recently described technique which may be an alternative to Paravertebral block (PVB) for providing thoracic analgesia. It involves injection of local anesthetic into the fascial plane deep to erector spinae muscle. ESP is a more superficial block with a better defined end-point injection between the bony transverse process and erector spinae muscle. A more superficial ultrasound-guided block will be faster to perform and less painful for the patient. ESP does not have the same risk of pneumothorax as PVB.
Epidural analgesia has become the standard of care. Although thoracic epidurals provide excellent analgesia for the management of rib fractures, they are limited to a certain population due to patient factors and side-effects. Many trauma patients have other injuries which contraindicate the use of epidurals, or which prevent positioning for insertion. There are disadvantages to thoracic epidural analgesia. They are technically challenging to insert, with a risk of dural puncture or spinal cord injury. Adverse effects include hypotension, and if opioids used, urinary retention and pruritus. Patients can develop a motor block and are unable to mobilize with an epidural in situ.
- Conditions
- Fracture; Rib, Multiple
- Being tested
- Ultrasound, Bupivacaine HCl Inj 0.25%, Bupivacaine Hydrochloride, 0.125%-0.9% Injectable Solution
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDevice
Ultrasound-guided Thoracic Epidural Analgesia and Erector spinae plane block.
Bupivacaine HCl Inj 0.25%Drug
Bupivacaine HCl Inj 0.25% will be used in both blocks by the same dose of 7.5-12 ml
Bupivacaine Hydrochloride, 0.125%-0.9% Injectable SolutionDrug
infusion of Bupivacaine Hydrochloride, 0.125%-0.9% Injectable Solution at 5-7 ml/h will be used in both blocks and also for breakthrough pain after both blocks as a bolus of 5-10 ml.
| Study group | Role | What they receive |
|---|---|---|
| Thoracic Epidural Analgesia group | Active comparator | 25 patients will receive ultrasound-guided thoracic epidural analgesia for multiple fracture ribs at the level of T8 with 7.5-12 ml of Bupivacaine HCl Inj 0.25% as a loading dose followed by catheter insertion and infusion of Bupivacaine Hydrochloride, 0.125%-0.9% Injectable Solution at 5-7 ml/h. For breakthrough pain bolus of Bupivacaine Hydrochloride, 0.125%-0.9% Injectable Solution 5-10 ml can be used. Receives: Device: Ultrasound; Drug: Bupivacaine HCl Inj 0.25%; Drug: Bupivacaine Hydrochloride, 0.125%-0.9% Injectable Solution |
| Erector spinae plane block group | Active comparator | 25 patients will receive ultrasound-guided ESP block for multiple fracture ribs at the level from T1 to T5 with 7.5-12 ml of Bupivacaine HCl Inj 0.25% as a loading dose followed by catheter insertion and infusion of Bupivacaine Hydrochloride, 0.125%-0.9% Injectable Solution at 5-7 ml/h. For breakthrough pain bolus of Bupivacaine Hydrochloride, 0.125%-0.9% Injectable Solution 5-10 ml can be used. Receives: Device: Ultrasound; Drug: Bupivacaine HCl Inj 0.25%; Drug: Bupivacaine Hydrochloride, 0.125%-0.9% Injectable Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score (verbal numeric rating scale) as the median VNRS at rest and cough
All patients will be assessed for pain score using the 11 points verbal numeric rating scale (VNRS), where zero equals no pain and 10 equals the worst pain imaginable. This assessment will be done before the block and after the block by 60 minutes and then every 6 hours up to 24 hours.
Measured: up to 24 hours
Secondary outcomes (1)
Pulmonary function test
Pulmonary function test will be done before the block, 60 minutes after the block and then every 6 hours up to 24 hours.
Measured: up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2019
- Study start1 Dec 2019
- Primary completion1 Dec 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fracture; Rib, MultipleStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rasha Hamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03853330
- Sponsor's protocol ID
- Analgesia for Fracture Ribs
- Status last verified
- Feb 2022
- First submitted
- 20 Feb 2019
- Last updated
- 14 Mar 2022
- 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 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erector Spinae Plane Block Versus Thoracic Epidural Analgesia in Patients With Multiple Fracture Ribs
- ClinicalTrials.gov ID
- NCT03853330
- Acronym / sponsor ID
- Analgesia for Fracture Ribs
- Conditions
- Fracture; Rib, Multiple
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 25 Feb 2019 (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.
To assess the analgesic and respiratory effect of continuous Erector Spinae Plane block versus Thoracic Epidural in patients with multiple fracture ribs.
Detailed description
Erector spinae plane (ESP) block is a recently described technique which may be an alternative to Paravertebral block (PVB) for providing thoracic analgesia. It involves injection of local anesthetic into the fascial plane deep to erector spinae muscle. ESP is a more superficial block with a better defined end-point injection between the bony transverse process and erector spinae muscle. A more superficial ultrasound-guided block will be faster to perform and less painful for the patient. ESP does not have the same risk of pneumothorax as PVB.
Epidural analgesia has become the standard of care. Although thoracic epidurals provide excellent analgesia for the management of rib fractures, they are limited to a certain population due to patient factors and side-effects. Many trauma patients have other injuries which contraindicate the use of epidurals, or which prevent positioning for insertion. There are disadvantages to thoracic epidural analgesia. They are technically challenging to insert, with a risk of dural puncture or spinal cord injury. Adverse effects include hypotension, and if opioids used, urinary retention and pruritus. Patients can develop a motor block and are unable to mobilize with an epidural in situ.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thoracic Epidural Analgesia group | Active comparator | Device: Ultrasound, Drug: Bupivacaine HCl Inj 0.25%, Drug: Bupivacaine Hydrochloride, 0.125%-0.9% Injectable Solution25 patients will receive ultrasound-guided thoracic epidural analgesia for multiple fracture ribs at the level of T8 with 7.5-12 ml of Bupivacaine HCl Inj 0.25% as a loading dose followed by catheter insertion and infusion of Bupivacaine Hydrochloride, 0.125%-0.9% Injectable Solution at 5-7 ml/h. For breakthrough pain bolus of Bupivacaine Hydrochloride, 0.125%-0.9% Injectable Solution 5-10 ml can be used. |
| Erector spinae plane block group | Active comparator | Device: Ultrasound, Drug: Bupivacaine HCl Inj 0.25%, Drug: Bupivacaine Hydrochloride, 0.125%-0.9% Injectable Solution25 patients will receive ultrasound-guided ESP block for multiple fracture ribs at the level from T1 to T5 with 7.5-12 ml of Bupivacaine HCl Inj 0.25% as a loading dose followed by catheter insertion and infusion of Bupivacaine Hydrochloride, 0.125%-0.9% Injectable Solution at 5-7 ml/h. For breakthrough pain bolus of Bupivacaine Hydrochloride, 0.125%-0.9% Injectable Solution 5-10 ml can be used. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients with multiple fracture ribs.
Key exclusion criteria (6 listed)
- Patient refusal.
- Patients with pre-existing infection at the block site.
- Coagulopathy.
- Allergy to local anesthetics.
- Pre-existing neurological deficits.
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 |
|---|---|---|
| UltrasoundUltrasound-guided Thoracic Epidural Analgesia and Erector spinae plane block. | Device | Erector spinae plane block group, Thoracic Epidural Analgesia group |
| Bupivacaine HCl Inj 0.25%Bupivacaine HCl Inj 0.25% will be used in both blocks by the same dose of 7.5-12 ml | Drug | Erector spinae plane block group, Thoracic Epidural Analgesia group |
| Bupivacaine Hydrochloride, 0.125%-0.9% Injectable Solutioninfusion of Bupivacaine Hydrochloride, 0.125%-0.9% Injectable Solution at 5-7 ml/h will be used in both blocks and also for breakthrough pain after both blocks as a bolus of 5-10 ml. | Drug | Erector spinae plane block group, Thoracic Epidural Analgesia group |
Primary outcome
Pain score (verbal numeric rating scale) as the median VNRS at rest and cough
Time frame: up to 24 hours
All patients will be assessed for pain score using the 11 points verbal numeric rating scale (VNRS), where zero equals no pain and 10 equals the worst pain imaginable. This assessment will be done before the block and after the block by 60 minutes and then every 6 hours up to 24 hours.
1 secondary outcome
Pulmonary function test
Time frame: up to 24 hours
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 14 Mar 2022.
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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 Ultrasound, Bupivacaine HCl Inj 0.25% and Bupivacaine Hydrochloride, 0.125%-0.9% Injectable Solution in people with Fracture; Rib, Multiple, run by Assiut 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 1 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 14 Mar 2022. 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?
Pain score (verbal numeric rating scale) as the median VNRS at rest and cough (time frame: up to 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 14 Mar 2022.