Rib FracturesNCT05506761
Rhomboid Intercostal Block Combined With Sub-Serratus Plane Block Versus Erector Spinae Plane Block
A study testing ultrasound-guided erector spinae plane block and ultrasound-guided rhomboid intercostal block combined with sub-serratus plane block in people with Rib Fractures, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of this study is to assess the quality of analgesic efficacy and improvement of pulmonary function in patients with fracture ribs receiving either continuous rhomboid intercostal block combined with sub-serratus block or continuous erector spinae plane block by comparing and evaluating the differences between… Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Rib Fractures
- What is being tested?
- ultrasound-guided erector spinae plane block and ultrasound-guided rhomboid intercostal block combined with sub-serratus plane block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2022to 1 Jan 2023
- 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 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult patients between 21 - 60 years.
- Patients with blunt chest trauma.
- Multiple fracture ribs (at least 3 ribs).
- Patients with acute trauma less than 48 hours.
Who cannot join
- Patients with major trauma outside the chest wall e.g., severe traumatic brain injury or major abdominal visceral injuries.
- Patients with bilateral rib fractures.
- Patients that are intubated and mechanically ventilated.
- Pregnant Individuals.
- Patients with local deformity or infection at the site of injection.
- Sensitivity to local anesthetic drugs.
- Patients with flail chest.
- Patients with Suspected or diagnosed coagulopathy.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Tanta University Hospital
Tanta, Gharbia Governorate
About this study
Official title: Ultrasound-Guided Continuous Rhomboid Intercostal Block Combined With Sub-Serratus Plane Block Versus Continuous Erector Spinae Plane Block for Analgesia in Patients With Multiple Traumatic Rib Fractures
The aim of this study is to assess the quality of analgesic efficacy and improvement of pulmonary function in patients with fracture ribs receiving either continuous rhomboid intercostal block combined with sub-serratus block or continuous erector spinae plane block by comparing and evaluating the differences between the two techniques.
Read the detailed description
Rib fractures are common injuries usually following blunt thoracic trauma. Depending on the extent of the injury, rib fractures are associated with a high risk of pulmonary complications, requirement for critical care admission and mechanical ventilation with increased risk of mortality, especially in older patients.
Thoracic pain caused by rib fractures or chest contusion limits patients' coughing and deep breathing, which may cause atelectasis and pneumonia. Patients may also suffer from pulmonary contusion due to injuries and this situation may cause acute respiratory distress syndrome and/or respiratory failure.
The key points in the management of patients with rib fractures are a combination of adequate pain control, respiratory support and physiotherapy.
Previously, pain control of rib fractures has been managed with systemic analgesia alone, with only a minority of patients receiving regional anesthesia. The presence of comorbid conditions, debility and alterations in pharmacodynamics/pharmacokinetics in older patients often results in a higher incidence of adverse effects with systemic analgesia, especially when opioid analgesia is required.
Therefore, different kinds of analgesic techniques have been proposed, including epidural analgesia, local anesthetic infiltration, erector spinae plane (ESP) block, paravertebral block and serratus plane block (SAB) or a combination of the mentioned methods are used to relieve pain.
Erector spinae plane block (ESB) is a novel myofascial plane block introduced into clinical practice. It has been successfully utilized in the management of pain after both rib fractures and surgery of the abdomen and thorax, and in the management of chronic thoracic pain.
The ultrasound-guided rhomboid intercostal block (RIB) and rhomboid intercostal block combined with the sub-serratus plane (RISS) block are two new analgesic techniques work by anesthetizing the lateral cutaneous branches of the thoracic intercostal nerves and can be used in multiple clinical settings for chest wall and upper abdominal analgesia.
This study suggests that the use of ultrasound-guided continuous ESPB or continuous RIB may improve the analgesia in patients with multiple fracture ribs, decrease the opioid analgesia consumption, and improve the outcome.
- Conditions
- Rib Fractures
- Being tested
- ultrasound-guided erector spinae plane block, ultrasound-guided rhomboid intercostal block combined with sub-serratus plane block
- Keywords
- Rib Fractures, Intercostal nerve block
- Medical subject headings
- Rib Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound-guided erector spinae plane blockProcedure or surgery
Patients will receive 20 ml plain bupivacaine 0.25 % bolus, then 10 ml per hour plain bupivacaine 0.125 % continuous infusion via ultrasound-guided erector spinae plane block
ultrasound-guided rhomboid intercostal block combined with sub-serratus plane blockProcedure or surgery
Patients will receive 20 ml plain bupivacaine 0.25 % bolus, then 10 ml per hour plain bupivacaine 0.125 % continuous infusion via ultrasound-guided rhomboid intercostal block combined with sub-serratus plane block
| Study group | Role | What they receive |
|---|---|---|
| Group I | No intervention | This group includes patients with rib fractures receiving patient-controlled analgesia. |
| Group II | Experimental | This group includes patients with rib fractures receiving continuous ultrasound-guided erector spinae plane block. Receives: Procedure: ultrasound-guided erector spinae plane block |
| Group III | Experimental | This group includes patients with rib fractures receiving continuous ultrasound-guided rhomboid intercostal block combined with sub-serratus plane block. Receives: Procedure: ultrasound-guided rhomboid intercostal block combined with sub-serratus plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total opioid analgesic consumption per day
Measured: 4 days
Secondary outcomes (7)
change in pain scores by Numerical rating score (NRS) after the procedure
Measured: 4 days
Time to First rescue analgesic request.
Measured: 4 days
Patient satisfaction.
Measured: 4 days
Changes in heart rate.
Measured: 4 days
Changes in mean arterial blood pressure.
Measured: 4 days
Incidence of adverse effects.
Measured: 4 days
Incidence of respiratory complications.
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2022
- Study start1 Jan 2022
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Jan 2023 (estimated)
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 Rib FracturesStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Gamal Mahmoud ElNawagy, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05506761
- Sponsor's protocol ID
- 35167/12/21
- Status last verified
- Aug 2022
- First submitted
- 17 Aug 2022
- Last updated
- 18 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Peek J, Beks RB, Hietbrink F, Heng M, De Jong MB, Beeres FJP, Leenen LPH, Groenwold RHH, Houwert RM. Complications and outcome after rib fracture fixation: A systematic review. J Trauma Acute Care Surg. 2020 Aug;89(2):411-418. doi: 10.1097/TA.0000000000002716.
PubMed 32282759Bachoumas K, Levrat A, Le Thuaut A, Rouleau S, Groyer S, Dupont H, Rooze P, Eisenmann N, Trampont T, Bohe J, Rieu B, Chakarian JC, Godard A, Frederici L, Gelinotte S, Joret A, Roques P, Painvin B, Leroy C, Benedit M, Dopeux L, Soum E, Botoc V, Fartoukh M, Hausermann MH, Kamel T, Morin J, De Varax R, Plantefeve G, Herbland A, Jabaudon M, Duburcq T, Simon C, Chabanne R, Schneider F, Ganster F, Bruel C, Laggoune AS, Bregeaud D, Souweine B, Reignier J, Lascarrou JB. Epidural analgesia in ICU chest trauma patients with fractured ribs: retrospective study of pain control and intubation requirements. Ann Intensive Care. 2020 Aug 27;10(1):116. doi: 10.1186/s13613-020-00733-0.
PubMed 32852675Ostermann RC, Joestl J, Lang N, Tiefenboeck TM, Ohnesorg S, Platzer P, Hofbauer M. Thoracic Injuries in Pediatric Polytraumatized Patients: Epidemiology, Treatment and Outcome. Injury. 2021 Jun;52(6):1316-1320. doi: 10.1016/j.injury.2021.02.033. Epub 2021 Feb 17.
PubMed 33663803Dogrul BN, Kiliccalan I, Asci ES, Peker SC. Blunt trauma related chest wall and pulmonary injuries: An overview. Chin J Traumatol. 2020 Jun;23(3):125-138. doi: 10.1016/j.cjtee.2020.04.003. Epub 2020 Apr 20.
PubMed 32417043Warfield DJ Jr, Barre S, Adhikary SD. Current understanding of the fascial plane blocks for analgesia of the chest wall: techniques and indications update for 2020. Curr Opin Anaesthesiol. 2020 Oct;33(5):692-697. doi: 10.1097/ACO.0000000000000909.
PubMed 32826623O'Connell KM, Patel KV, Powelson E, Robinson BRH, Boyle K, Peschman J, Blocher-Smith EC, Jacobson L, Leavitt J, McCrum ML, Ballou J, Brasel KJ, Judge J, Greenberg S, Mukherjee K, Qiu Q, Vavilala MS, Rivara F, Arbabi S. Use of regional analgesia and risk of delirium in older adults with multiple rib fractures: An Eastern Association for the Surgery of Trauma multicenter study. J Trauma Acute Care Surg. 2021 Aug 1;91(2):265-271. doi: 10.1097/TA.0000000000003258.
PubMed 33938510Jiang CW, Liu F, Zhou Q, Deng W. Comparison of rhomboid intercostal nerve block, erector spinae plane block and serratus plane block on analgesia for modified radical mastectomy: A prospective randomised controlled trial. Int J Clin Pract. 2021 Oct;75(10):e14539. doi: 10.1111/ijcp.14539. Epub 2021 Jul 2.
PubMed 34133831Chin KJ, El-Boghdadly K. Mechanisms of action of the erector spinae plane (ESP) block: a narrative review. Can J Anaesth. 2021 Mar;68(3):387-408. doi: 10.1007/s12630-020-01875-2. Epub 2021 Jan 6.
PubMed 33403545
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-Guided Continuous Rhomboid Intercostal Block Combined With Sub-Serratus Plane Block Versus Continuous Erector Spinae Plane Block for Analgesia in Patients With Multiple Traumatic Rib Fractures
- ClinicalTrials.gov ID
- NCT05506761
- Acronym / sponsor ID
- 35167/12/21
- Conditions
- Rib Fractures
- Keywords
- Rib Fractures, Intercostal nerve block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 18 Aug 2022 (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 study is to assess the quality of analgesic efficacy and improvement of pulmonary function in patients with fracture ribs receiving either continuous rhomboid intercostal block combined with sub-serratus block or continuous erector spinae plane block by comparing and evaluating the differences between the two techniques.
Detailed description
Rib fractures are common injuries usually following blunt thoracic trauma. Depending on the extent of the injury, rib fractures are associated with a high risk of pulmonary complications, requirement for critical care admission and mechanical ventilation with increased risk of mortality, especially in older patients.
Thoracic pain caused by rib fractures or chest contusion limits patients' coughing and deep breathing, which may cause atelectasis and pneumonia. Patients may also suffer from pulmonary contusion due to injuries and this situation may cause acute respiratory distress syndrome and/or respiratory failure.
The key points in the management of patients with rib fractures are a combination of adequate pain control, respiratory support and physiotherapy.
Previously, pain control of rib fractures has been managed with systemic analgesia alone, with only a minority of patients receiving regional anesthesia. The presence of comorbid conditions, debility and alterations in pharmacodynamics/pharmacokinetics in older patients often results in a higher incidence of adverse effects with systemic analgesia, especially when opioid analgesia is required.
Therefore, different kinds of analgesic techniques have been proposed, including epidural analgesia, local anesthetic infiltration, erector spinae plane (ESP) block, paravertebral block and serratus plane block (SAB) or a combination of the mentioned methods are used to relieve pain.
Erector spinae plane block (ESB) is a novel myofascial plane block introduced into clinical practice. It has been successfully utilized in the management of pain after both rib fractures and surgery of the abdomen and thorax, and in the management of chronic thoracic pain.
The ultrasound-guided rhomboid intercostal block (RIB) and rhomboid intercostal block combined with the sub-serratus plane (RISS) block are two new analgesic techniques work by anesthetizing the lateral cutaneous branches of the thoracic intercostal nerves and can be used in multiple clinical settings for chest wall and upper abdominal analgesia.
This study suggests that the use of ultrasound-guided continuous ESPB or continuous RIB may improve the analgesia in patients with multiple fracture ribs, decrease the opioid analgesia consumption, and improve the outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I | No intervention | –This group includes patients with rib fractures receiving patient-controlled analgesia. |
| Group II | Experimental | Procedure: ultrasound-guided erector spinae plane blockThis group includes patients with rib fractures receiving continuous ultrasound-guided erector spinae plane block. |
| Group III | Experimental | Procedure: ultrasound-guided rhomboid intercostal block combined with sub-serratus plane blockThis group includes patients with rib fractures receiving continuous ultrasound-guided rhomboid intercostal block combined with sub-serratus plane block. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adult patients between 21 - 60 years.
- Patients with blunt chest trauma.
- Multiple fracture ribs (at least 3 ribs).
- Patients with acute trauma less than 48 hours.
Key exclusion criteria (8 listed)
- Patients with major trauma outside the chest wall e.g., severe traumatic brain injury or major abdominal visceral injuries.
- Patients with bilateral rib fractures.
- Patients that are intubated and mechanically ventilated.
- Pregnant Individuals.
- Patients with local deformity or infection at the site of injection.
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 erector spinae plane blockPatients will receive 20 ml plain bupivacaine 0.25 % bolus, then 10 ml per hour plain bupivacaine 0.125 % continuous infusion via ultrasound-guided erector spinae plane block | Procedure or surgery | Group II |
| ultrasound-guided rhomboid intercostal block combined with sub-serratus plane blockPatients will receive 20 ml plain bupivacaine 0.25 % bolus, then 10 ml per hour plain bupivacaine 0.125 % continuous infusion via ultrasound-guided rhomboid intercostal block combined with sub-serratus plane block | Procedure or surgery | Group III |
Primary outcome
Total opioid analgesic consumption per day
Time frame: 4 days
7 secondary outcomes
change in pain scores by Numerical rating score (NRS) after the procedure
Time frame: 4 days
Time to First rescue analgesic request.
Time frame: 4 days
Patient satisfaction.
Time frame: 4 days
Changes in heart rate.
Time frame: 4 days
Changes in mean arterial blood pressure.
Time frame: 4 days
Incidence of adverse effects.
Time frame: 4 days
Incidence of respiratory complications.
Time frame: 4 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2022.
- Background: PubMed 32282759Peek J, Beks RB, Hietbrink F, Heng M, De Jong MB, Beeres FJP, Leenen LPH, Groenwold RHH, Houwert RM. Complications and outcome after rib fracture fixation: A systematic review. J Trauma Acute Care Surg. 2020 Aug;89(2):411-418. doi: 10.1097/TA.0000000000002716.
- Background: PubMed 32852675Bachoumas K, Levrat A, Le Thuaut A, Rouleau S, Groyer S, Dupont H, Rooze P, Eisenmann N, Trampont T, Bohe J, Rieu B, Chakarian JC, Godard A, Frederici L, Gelinotte S, Joret A, Roques P, Painvin B, Leroy C, Benedit M, Dopeux L, Soum E, Botoc V, Fartoukh M, Hausermann MH, Kamel T, Morin J, De Varax R, Plantefeve G, Herbland A, Jabaudon M, Duburcq T, Simon C, Chabanne R, Schneider F, Ganster F, Bruel C, Laggoune AS, Bregeaud D, Souweine B, Reignier J, Lascarrou JB. Epidural analgesia in ICU chest trauma patients with fractured ribs: retrospective study of pain control and intubation requirements. Ann Intensive Care. 2020 Aug 27;10(1):116. doi: 10.1186/s13613-020-00733-0.
- Background: PubMed 33663803Ostermann RC, Joestl J, Lang N, Tiefenboeck TM, Ohnesorg S, Platzer P, Hofbauer M. Thoracic Injuries in Pediatric Polytraumatized Patients: Epidemiology, Treatment and Outcome. Injury. 2021 Jun;52(6):1316-1320. doi: 10.1016/j.injury.2021.02.033. Epub 2021 Feb 17.
- Background: PubMed 32417043Dogrul BN, Kiliccalan I, Asci ES, Peker SC. Blunt trauma related chest wall and pulmonary injuries: An overview. Chin J Traumatol. 2020 Jun;23(3):125-138. doi: 10.1016/j.cjtee.2020.04.003. Epub 2020 Apr 20.
- Background: PubMed 32826623Warfield DJ Jr, Barre S, Adhikary SD. Current understanding of the fascial plane blocks for analgesia of the chest wall: techniques and indications update for 2020. Curr Opin Anaesthesiol. 2020 Oct;33(5):692-697. doi: 10.1097/ACO.0000000000000909.
- Background: PubMed 33938510O'Connell KM, Patel KV, Powelson E, Robinson BRH, Boyle K, Peschman J, Blocher-Smith EC, Jacobson L, Leavitt J, McCrum ML, Ballou J, Brasel KJ, Judge J, Greenberg S, Mukherjee K, Qiu Q, Vavilala MS, Rivara F, Arbabi S. Use of regional analgesia and risk of delirium in older adults with multiple rib fractures: An Eastern Association for the Surgery of Trauma multicenter study. J Trauma Acute Care Surg. 2021 Aug 1;91(2):265-271. doi: 10.1097/TA.0000000000003258.
- Background: PubMed 34133831Jiang CW, Liu F, Zhou Q, Deng W. Comparison of rhomboid intercostal nerve block, erector spinae plane block and serratus plane block on analgesia for modified radical mastectomy: A prospective randomised controlled trial. Int J Clin Pract. 2021 Oct;75(10):e14539. doi: 10.1111/ijcp.14539. Epub 2021 Jul 2.
- Background: PubMed 33403545Chin KJ, El-Boghdadly K. Mechanisms of action of the erector spinae plane (ESP) block: a narrative review. Can J Anaesth. 2021 Mar;68(3):387-408. doi: 10.1007/s12630-020-01875-2. Epub 2021 Jan 6.
- Individual participant dataSharing planned: No
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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.
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-guided erector spinae plane block and ultrasound-guided rhomboid intercostal block combined with sub-serratus plane block in people with Rib Fractures, run by Tanta 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 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: status not confirmed, as of the sponsor's last update on 18 Aug 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed G. ElNawagy (01158170077 ext. 20, ahmed.nawagy@med.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total opioid analgesic consumption per day (time frame: 4 days). 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 NCT05506761, 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 18 Aug 2022.