PainPhase 4NCT05965895
Ultrasound-Guided Continuous Serratus Anterior Plane Block vs Dexmedetomidine Infusion in Patients With Rib Fractures.
A Phase 4 study testing Ultrasound-guided continuous serratus anterior plane block and intravenous dexmedetomidine infusion in people with Pain, run by Beni-Suef University at 1 site in Egypt.
Trial summary
The aim of this work is to compare analgesic efficacy in patients with multiple rib fractures who will be managed with Ultrasound-guided continuous serratus anterior plane block versus patients who will be managed with dexmedetomidine infusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- Ultrasound-guided continuous serratus anterior plane block and intravenous dexmedetomidine infusion
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2023to 1 Aug 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Rib fracture score of more than 7
- Patient with isolated multiple rib fractures, ●American Society of Anesthesiologists classification of physical status < IV
- Body mass index (BMI) ≤ 35.
Who cannot join
- Refusal of the patient
- Trauma survey include multiple injuries including head injuries, visceral and long bone fractures
- Intubated patients
- Known hypersensitivity to any study medication, ●Chronic opioid use or chronic pain patient, ●Hemodynamic instability
- Haemothorax or pneumothorax.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Beni-Suef University hospital
Banī Suwayf, Beni Suweif Governorate, 62814
Dina M Fakhry, MD, +201289998680, dina_fakhry_91@yahoo.com
About this study
Official title: Ultrasound-Guided Continuous Serratus Anterior Plane Block Versus Intravenous Dexmedetomidine Infusion for Pain Control in Patients With Multiple Rib Fractures: A Prospective Randomized Clinical Trial.
The aim of this work is to compare analgesic efficacy in patients with multiple rib fractures who will be managed with Ultrasound-guided continuous serratus anterior plane block versus patients who will be managed with dexmedetomidine infusion.
Read the detailed description
In thoracic trauma patients with rib fractures, the ability to cough and clear secretions is impaired by pain, leading to an increased risk of atelectasis, retention of secretions, chest infections and prolonged ICU stay thereby leads to significant morbidity, mortality and cost of treatment.Hence, aggressive pain management is a vital component of rib fracture management for the healing of rib fractures, improvement of pulmonary functions, and pulmonary rehabilitation.
The number of rib fractures >3, rib fracture locations, bilateral rib fractures, intraparenchymal pulmonary injuries, flail chest, and a first rib fracture influence the mortality rates.
The involvement of acute pain services in Multiple rib fractures (MRFs) is based on "Rib Fracture score". Rib fracture score = (breaks × sides) + age factor. "Breaks" is the total number of fractures to the rib. Score of 1 is for unilateral fractures and 2 for bilateral fractures. Age is factored into the equation due to an increased risk of complications (age factor = 0 if <50 years; 1 if 51-60 years; 2 if 61-70 years; 3 if 71-80 years; 4 if above 80 years). A score >7, requires the involvement of acute pain team.
There is a wide variety of strategies for treating acute pain , including multimodal opioid and non-opioid systemic analgesics, regional anesthesia including thoracic epidural analgesia (TEA), paravertebral blocks (PVB),intercostal nerve blocks and a recent expansion in the use of novel fascial plane blocks.
Ultrasound-guided Serratus Anterior Plane (SAP) block is an ultrasound (US) guided interfascial plane block which has been used in managing pain due to MRFs. It is a relatively recent technique, first described in 2013, that provides almost complete analgesia for the thoracic wall by blocking the lateral branches of the intercostal nerves from T2 to L2. Two planes were described, one superficial to serratus anterior muscle and second underneath the muscle and above the rib. It is a safe, simple to perform block with no significant contraindications or side effects. It can be performed in patients lying supine, rendering it particularly useful in polytrauma patients who are unable to sit up or turn lateral for regional blocks on the back. It can be safely given to polytrauma patients who may be having hemodynamic instability or coagulopathy, unlike epidural and paravertebral. There is a theoretical possibility of local anesthetic toxicity and hematoma such as other interfacial plane blocks. Pneumothorax is a potential complication, but under ultrasound guidance, it would be a remote possibility as the injection is far from the pleura between two muscles or above the rib.
Use of continuous techniques using catheters has the benefit of providing prolonged analgesia titrated to patient response.
Dexmedetomidine is a highly selective α-2 adrenoceptor agonist. It has sympatholytic, sedative, amnestic, and analgesic properties. It provides a unique analgesia, without respiratory depression best described as opioid- sparing. The analgesic properties of α-2 agonists are mediated by Supraspinal (locus ceruleus) and spinal (dorsal horn) mechanisms. Also it decreases sympathetic outflow through a central action in a dose-dependent manner, and these presynaptic sites of action are clinically significant because they modulate the release of norepinephrine. This inhibitory effect on neurotransmitter release is mediated by the blockage of calcium entry into nerve terminals. Systemic administration of the α-2 agonists has been tested in the perioperative period. The reduced opioid requirement was a feature of the administration of such group of medications. This feature is indirect evidence that these drugs have analgesic action. However, the perioperative period involves many conflicting factors. Clearly, the sedative effect may be the reason behind the reduced opioid requirements.
- Conditions
- Pain
- Being tested
- Ultrasound-guided continuous serratus anterior plane block, intravenous dexmedetomidine infusion
- Keywords
- Serratus anterior, Dexmedetomidine, Rib, Fractures
- Medical subject headings
- Pain, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided continuous serratus anterior plane blockProcedure or surgery
Also called Group S
Patients will receive US-guided SAP block with a bolus of 2 mg/kg levobupivacaine made up to a volume of 40 ml followed by an infusion of 0.125% levobupivacaine will be commenced at rate of 8 ml/hr for 48 hr.
intravenous dexmedetomidine infusionDrug
Also called Group D
Patients will receive initial loading dose of dexmedetomidine of 1 µg/kg over 30 min followed by a continuous infusion at a rate of 0.5 µg/kg/hr for 48 hr.
| Study group | Role | What they receive |
|---|---|---|
| US-guided SAP block group | Active comparator | Patients will receive US-guided SAP block with a bolus of 2 mg/kg levobupivacaine made up to a volume of 40 ml followed by an infusion of 0.125% levobupivacaine will be commenced at rate of 8 ml/hr for 48 hr. Receives: Procedure: Ultrasound-guided continuous serratus anterior plane block |
| Dexmedetomidine group | Active comparator | Patients will receive initial loading dose of dexmedetomidine of 1 µg/kg over 30 min followed by a continuous infusion at a rate of 0.5 µg/kg/hr for 48 hr. Receives: Drug: intravenous dexmedetomidine infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of analgesia measured by visual analogue scale
rate pain severity scored from 0 to 10; while 0 stands for no pain at all and 10 is the worst intolerable pain.
Measured: The first 48 hours.
Secondary outcomes (2)
parameters of adequate ventilation and oxygenation
PaO2/FiO2 ratio and PaCO2 will be recorded
Measured: at 1, 2, 3, 4, 8, 16, 24, 36, 48 hours.
Sedation score
Ramsay score was used to evaluate sedation. Score 1 represents agitated and uncomfortable patient. Score 2 represents cooperative and orientated patient. Score 3 represents a patient who can follow simple directions. Score 4 represents an asleep patient with a strong response to stimulation. Score 5 represents an asleep patient with a slow response to stimulation. Score 6 represents an asleep patient with no response to stimulation.
Measured: Every 8 hours for 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start1 Aug 2023
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Beni-Suef 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Mahmoud Fakhry, Beni-Suef University
- Investigators
- Dina M Fakhry, MD, Principal investigator, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05965895
- Sponsor's protocol ID
- FMBSUREC/09072023/Fakhry
- Status last verified
- Oct 2023
- First submitted
- 20 Jul 2023
- Last updated
- 11 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-Guided Continuous Serratus Anterior Plane Block Versus Intravenous Dexmedetomidine Infusion for Pain Control in Patients With Multiple Rib Fractures: A Prospective Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT05965895
- Acronym / sponsor ID
- FMBSUREC/09072023/Fakhry
- Conditions
- Pain
- Keywords
- Serratus anterior, Dexmedetomidine, Rib, Fractures
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 28 Jul 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 aim of this work is to compare analgesic efficacy in patients with multiple rib fractures who will be managed with Ultrasound-guided continuous serratus anterior plane block versus patients who will be managed with dexmedetomidine infusion.
Detailed description
In thoracic trauma patients with rib fractures, the ability to cough and clear secretions is impaired by pain, leading to an increased risk of atelectasis, retention of secretions, chest infections and prolonged ICU stay thereby leads to significant morbidity, mortality and cost of treatment.Hence, aggressive pain management is a vital component of rib fracture management for the healing of rib fractures, improvement of pulmonary functions, and pulmonary rehabilitation.
The number of rib fractures >3, rib fracture locations, bilateral rib fractures, intraparenchymal pulmonary injuries, flail chest, and a first rib fracture influence the mortality rates.
The involvement of acute pain services in Multiple rib fractures (MRFs) is based on "Rib Fracture score". Rib fracture score = (breaks × sides) + age factor. "Breaks" is the total number of fractures to the rib. Score of 1 is for unilateral fractures and 2 for bilateral fractures. Age is factored into the equation due to an increased risk of complications (age factor = 0 if <50 years; 1 if 51-60 years; 2 if 61-70 years; 3 if 71-80 years; 4 if above 80 years). A score >7, requires the involvement of acute pain team.
There is a wide variety of strategies for treating acute pain , including multimodal opioid and non-opioid systemic analgesics, regional anesthesia including thoracic epidural analgesia (TEA), paravertebral blocks (PVB),intercostal nerve blocks and a recent expansion in the use of novel fascial plane blocks.
Ultrasound-guided Serratus Anterior Plane (SAP) block is an ultrasound (US) guided interfascial plane block which has been used in managing pain due to MRFs. It is a relatively recent technique, first described in 2013, that provides almost complete analgesia for the thoracic wall by blocking the lateral branches of the intercostal nerves from T2 to L2. Two planes were described, one superficial to serratus anterior muscle and second underneath the muscle and above the rib. It is a safe, simple to perform block with no significant contraindications or side effects. It can be performed in patients lying supine, rendering it particularly useful in polytrauma patients who are unable to sit up or turn lateral for regional blocks on the back. It can be safely given to polytrauma patients who may be having hemodynamic instability or coagulopathy, unlike epidural and paravertebral. There is a theoretical possibility of local anesthetic toxicity and hematoma such as other interfacial plane blocks. Pneumothorax is a potential complication, but under ultrasound guidance, it would be a remote possibility as the injection is far from the pleura between two muscles or above the rib.
Use of continuous techniques using catheters has the benefit of providing prolonged analgesia titrated to patient response.
Dexmedetomidine is a highly selective α-2 adrenoceptor agonist. It has sympatholytic, sedative, amnestic, and analgesic properties. It provides a unique analgesia, without respiratory depression best described as opioid- sparing. The analgesic properties of α-2 agonists are mediated by Supraspinal (locus ceruleus) and spinal (dorsal horn) mechanisms. Also it decreases sympathetic outflow through a central action in a dose-dependent manner, and these presynaptic sites of action are clinically significant because they modulate the release of norepinephrine. This inhibitory effect on neurotransmitter release is mediated by the blockage of calcium entry into nerve terminals. Systemic administration of the α-2 agonists has been tested in the perioperative period. The reduced opioid requirement was a feature of the administration of such group of medications. This feature is indirect evidence that these drugs have analgesic action. However, the perioperative period involves many conflicting factors. Clearly, the sedative effect may be the reason behind the reduced opioid requirements.
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 |
|---|---|---|
| US-guided SAP block group | Active comparator | Procedure: Ultrasound-guided continuous serratus anterior plane blockPatients will receive US-guided SAP block with a bolus of 2 mg/kg levobupivacaine made up to a volume of 40 ml followed by an infusion of 0.125% levobupivacaine will be commenced at rate of 8 ml/hr for 48 hr. |
| Dexmedetomidine group | Active comparator | Drug: intravenous dexmedetomidine infusionPatients will receive initial loading dose of dexmedetomidine of 1 µg/kg over 30 min followed by a continuous infusion at a rate of 0.5 µg/kg/hr for 48 hr. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years
- Rib fracture score of more than 7
- Patient with isolated multiple rib fractures, ●American Society of Anesthesiologists classification of physical status < IV
- Body mass index (BMI) ≤ 35.
Key exclusion criteria (5 listed)
- Refusal of the patient
- Trauma survey include multiple injuries including head injuries, visceral and long bone fractures
- Intubated patients
- Known hypersensitivity to any study medication, ●Chronic opioid use or chronic pain patient, ●Hemodynamic instability
- Haemothorax or pneumothorax.
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 |
|---|---|---|
| Ultrasound-guided continuous serratus anterior plane blockAlso: Group SPatients will receive US-guided SAP block with a bolus of 2 mg/kg levobupivacaine made up to a volume of 40 ml followed by an infusion of 0.125% levobupivacaine will be commenced at rate of 8 ml/hr for 48 hr. | Procedure or surgery | US-guided SAP block group |
| intravenous dexmedetomidine infusionAlso: Group DPatients will receive initial loading dose of dexmedetomidine of 1 µg/kg over 30 min followed by a continuous infusion at a rate of 0.5 µg/kg/hr for 48 hr. | Drug | Dexmedetomidine group |
Primary outcome
Quality of analgesia measured by visual analogue scale
Time frame: The first 48 hours.
rate pain severity scored from 0 to 10; while 0 stands for no pain at all and 10 is the worst intolerable pain.
2 secondary outcomes
parameters of adequate ventilation and oxygenation
Time frame: at 1, 2, 3, 4, 8, 16, 24, 36, 48 hours.
Sedation score
Time frame: Every 8 hours for 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2023.
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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.
Dina M Fakhry, MD principal investigator
Beni-Suef University
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 Ultrasound-guided continuous serratus anterior plane block and intravenous dexmedetomidine infusion in people with Pain, run by Beni-Suef 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 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 11 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dina M Fakhry, MD (+201289998680, dina_fakhry_91@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of analgesia measured by visual analogue scale (time frame: The first 48 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 11 Oct 2023.