- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06958549
- Original Trial
Role of Nerve Block in Management of Multiple Rib Fractures
Management of Multiple Rib Fractures; Role of Nerve Block
- Epidemiology & Impact Thoracic trauma is a common and serious injury worldwide-especially in developing countries-and carries high rates of morbidity and mortality. Complications arise primarily from hypoventilation, which leads to atelectasis, pneumonia, and respiratory failure.
- Key to Reducing Complications: Pain Control Effective analgesia is the cornerstone of preventing respiratory complications. Inadequate pain relief causes patients to splint and hypoventilate, setting the stage for pulmonary collapse and infection.
- Conservative Management
- Analgesics: Systemic pharmacological pain relief remains the mainstay.
- Supportive Measures: Rest, application of ice, and encouragement of deep breathing exercises.
- Incentive Spirometry: Promoted in all patients to maintain lung expansion and ward off atelectasis.
- Regional Anesthesia Techniques
To further improve comfort and respiratory mechanics, ultrasound-guided nerve blocks are employed according to fracture location:
- Serratus Anterior Plane Block for anterolateral rib fractures
- Thoracic Paravertebral Block for posterior rib fractures
- Surgical Intervention Reserved for complex cases-such as flail chest or fractures with risk of organ injury-where stabilization or repair may be necessary.
- Identified Gap Despite these options, thoracic surgeons currently lack a standardized, procedure-specific pain management protocol beyond systemic analgesics, highlighting a need for consensus guidelines that integrate pharmacological and regional techniques.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Thoracic trauma is a major traumatic injury throughout the world, and it has very high incidence in developing countries. Thoracic trauma is often associated with significant morbidity and mortality. Morbidity is due to atelectasis, pneumonia, and respiratory failure as a sequence of hypoventilation.
Most important factor in preventing complications in these patients is pain management. There are different lines of management of multiple rib fractures; conservative therapy is a common line of management which includes appropriate analgesic, rest, and ice.
The use of an incentive spirometer should be encouraged to prevent pulmonary atelectasis and splinting.
Nerve block can also be applied to aid in pain control, surgery may also be a line of management for complicated cases.
The type of nerve block differs according to the site of the fracture; Ultrasound-Guided Serratus Anterior Plane Block is often used for anterolateral rib fractures and Ultrasound-Guided Thoracic Paravertebral Block is used for posterior rib fractures.
The problem here is that ; There is no pain management protocol to be done by thoracic surgeons other than pharmacological analgesics.
This randomized prospective study will be performed in Assiut University Hospitals on two groups of trauma patients, each group is 37 patients; one will undergo nerve block by injection of Lidocaine (7mg/kg) with Epinephrine 1:100000 under ultrasonographical guidance and the other will receive pharmacological analgesics (Oral Paracetamol (500mg/6hr), IV Ketolac (15mg/6hr) and IV perfelgan (1gm/6hr)).
Then improvement in patients pain score, intercostal tube duration in days and total hospital stay in days, patient satisfaction using questionnaire will be assessed.
Study Type
Enrollment (Estimated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Mostafa A Kotb
- Phone Number: +201091703324
- Email: Moustafa.16266040@med.aun.edu.eg
Study Contact Backup
- Name: Ahmed M Nabil
- Phone Number: +201005016071
- Email: ahmednabil@aun.adu.eg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- All trauma adult patient (18-70 years) with multiple fracture ribs
Exclusion Criteria:
- Patient with multiple fracture rib with anterior flail segment
- Significant head trauma
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: nerve block
|
Injection of Lidocaine (7mg/kg) with Epinephrine 1:100000 under Ultrasonographical guidance
|
|
Active Comparator: pharmacological analgesics
|
Oral Paracetamol (500mg/6hr), IV Ketolac (15mg/6hr) and IV perfelgan (1gm/6hr)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Improvement in patients pain score (neumerical score)
Time Frame: day 0, day 1 and day 3
|
day 0, day 1 and day 3
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
improving intercostal tube duration in days
Time Frame: day 2, day 4 and day 6
|
day 2, day 4 and day 6
|
|
improving total hospital stay in days
Time Frame: day 2, day 4 and day 6
|
day 2, day 4 and day 6
|
|
improving patient satisfaction (questionnaire)
Time Frame: day 0, day 2, day 4 and day 6
|
day 0, day 2, day 4 and day 6
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Easter A. Management of patients with multiple rib fractures. Am J Crit Care. 2001 Sep;10(5):320-7; quiz 328-9.
- Kring RM, Mackenzie DC, Wilson CN, Rappold JF, Strout TD, Croft PE. Ultrasound-Guided Serratus Anterior Plane Block (SAPB) Improves Pain Control in Patients With Rib Fractures. J Ultrasound Med. 2022 Nov;41(11):2695-2701. doi: 10.1002/jum.15953. Epub 2022 Feb 2.
- Hwang EG, Lee Y. Effectiveness of intercostal nerve block for management of pain in rib fracture patients. J Exerc Rehabil. 2014 Aug 31;10(4):241-4. doi: 10.12965/jer.140137. eCollection 2014 Aug.
- Yayik AM, Aydin ME, Tekin E, Ulas AB, Ahiskalioglu A. An alternative plane block for multiple rib fractures: Rhomboid Intercostal and Sub-Serratus block (RISS). Am J Emerg Med. 2019 Dec;37(12):2263.e5-2263.e7. doi: 10.1016/j.ajem.2019.158429. Epub 2019 Sep 6.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Wounds and Injuries
- Thoracic Injuries
- Fractures, Bone
- Rib Fractures
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Anesthetics, Local
- Anesthetics
- Central Nervous System Depressants
- Sensory System Agents
- Anti-Arrhythmia Agents
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Membrane Transport Modulators
- Lidocaine
- Analgesics
Other Study ID Numbers
- RIBFRACTURE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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