Rhomboid Intercostal Block Combined With Sub-Serratus Plane Block Versus Erector Spinae Plane Block
Primary Purpose
Rib Fractures
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
ultrasound-guided erector spinae plane block
ultrasound-guided rhomboid intercostal block combined with sub-serratus plane block
Sponsored by
About this trial
This is an interventional treatment trial for Rib Fractures focused on measuring Rib Fractures, Intercostal nerve block
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Tanta University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
Group I
Group II
Group III
Arm Description
This group includes patients with rib fractures receiving patient-controlled analgesia.
This group includes patients with rib fractures receiving continuous ultrasound-guided erector spinae plane block.
This group includes patients with rib fractures receiving continuous ultrasound-guided rhomboid intercostal block combined with sub-serratus plane block.
Outcomes
Primary Outcome Measures
Total opioid analgesic consumption per day
Secondary Outcome Measures
change in pain scores by Numerical rating score (NRS) after the procedure
Time to First rescue analgesic request.
Patient satisfaction.
Changes in heart rate.
Changes in mean arterial blood pressure.
Incidence of adverse effects.
Incidence of respiratory complications.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05506761
Brief Title
Rhomboid Intercostal Block Combined With Sub-Serratus Plane Block Versus Erector Spinae Plane Block
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
January 1, 2023 (Anticipated)
Study Completion Date
January 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rib Fractures
Keywords
Rib Fractures, Intercostal nerve block
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group I
Arm Type
No Intervention
Arm Description
This group includes patients with rib fractures receiving patient-controlled analgesia.
Arm Title
Group II
Arm Type
Experimental
Arm Description
This group includes patients with rib fractures receiving continuous ultrasound-guided erector spinae plane block.
Arm Title
Group III
Arm Type
Experimental
Arm Description
This group includes patients with rib fractures receiving continuous ultrasound-guided rhomboid intercostal block combined with sub-serratus plane block.
Intervention Type
Procedure
Intervention Name(s)
ultrasound-guided erector spinae plane block
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
ultrasound-guided rhomboid intercostal block combined with sub-serratus plane block
Intervention Description
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
Primary Outcome Measure Information:
Title
Total opioid analgesic consumption per day
Time Frame
4 days
Secondary Outcome Measure Information:
Title
change in pain scores by Numerical rating score (NRS) after the procedure
Time Frame
4 days
Title
Time to First rescue analgesic request.
Time Frame
4 days
Title
Patient satisfaction.
Time Frame
4 days
Title
Changes in heart rate.
Time Frame
4 days
Title
Changes in mean arterial blood pressure.
Time Frame
4 days
Title
Incidence of adverse effects.
Time Frame
4 days
Title
Incidence of respiratory complications.
Time Frame
4 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed G. ElNawagy
Phone
01158170077
Ext
20
Email
ahmed.nawagy@med.tanta.edu.eg
Facility Information:
Facility Name
Tanta University Hospital
City
Tanta
State/Province
Gharbia
Country
Egypt
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32282759
Citation
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.
Results Reference
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PubMed Identifier
32852675
Citation
Bachoumas 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.
Results Reference
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PubMed Identifier
33663803
Citation
Ostermann 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.
Results Reference
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PubMed Identifier
32417043
Citation
Dogrul 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.
Results Reference
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PubMed Identifier
32826623
Citation
Warfield 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.
Results Reference
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PubMed Identifier
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Citation
O'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.
Results Reference
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Citation
Jiang 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.
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Rhomboid Intercostal Block Combined With Sub-Serratus Plane Block Versus Erector Spinae Plane Block
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