Forearm FractureNCT06588907
Pain Palliation in Forearm Fractures in the Emergency Department
A study testing Bupivacaine Hydrochloride and Ketamine in people with Forearm Fracture and Radius Fractures, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim is to evaluate the success of reduction procedures and pain palliation in patients with forearm fractures undergoing reduction under procedural sedation-analgesia (PSA) and ultrasound (US)-guided infraclavicular nerve block (ICB) in the emergency department. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Forearm Fracture, Radius Fractures, Ulnar Fracture
- What is being tested?
- Bupivacaine Hydrochloride and Ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2024to 15 Dec 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years and older,
- Diagnosed with forearm fracture using standard radiography,
- Hemodynamically stable individuals,
- Without vascular or nerve injury,
- Without infection in the skin or tissues where the needle will pass,
- Able to provide written and verbal consent and are capable of giving consent
Who cannot join
- Those with allergies to drugs used for sedoanalgesia and peripheral nerve blockade,
- Those who are hemodynamically unstable,
- Patients with ASA (American Society of Anesthesiologists) classification 3-4 will not be included in the group for whom PSA will be applied,
- Patients with coagulopathy, liver, or kidney failure,
- Patients with opioid, alcohol, or substance dependency,
- Those with skin infections or open wounds in the area where local anesthetic will be administered,
- Pregnant or suspected pregnant individuals,
- Those who do not provide written and verbal consent.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Etlik City Hospital
Ankara, Yenimahalle, 38000
About this study
Official title: Evaluation of the Efficacy of Procedural Sedoanalgesia and Infraclavicular Nerve Blockade on Analgesia in Forearm Fractures in the Emergency Department
The aim is to evaluate the success of reduction procedures and pain palliation in patients with forearm fractures undergoing reduction under procedural sedation-analgesia (PSA) and ultrasound (US)-guided infraclavicular nerve block (ICB) in the emergency department.
Read the detailed description
Forearm fractures are among the most frequent reasons for adults to visit the emergency department. These fractures cause significant pain both due to the fracture itself and during the reduction process. Pain management in emergency departments (ED) is crucial. Therefore, multimodal approaches are available to reduce or eliminate pain during the reduction process. The aim of this study is to evaluate the success and pain palliation of the reduction process with procedural sedation-analgesia (PSA) and with reduction under ultrasound (US)-guided infraclavicular nerve block (ICB) in patients with forearm fractures. The secondary aim is to compare patient comfort, physician comfort, side effects, length of stay in the emergency department, and the need for painkillers after discharge between these two procedures, and to identify the most suitable method. This study aims to contribute to practical applications in order to provide optimal pain control in patients with forearm fractures in emergency departments.
Patients' pain levels at arrival, pre-reduction procedure, and post-reduction procedure will be recorded using the Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain).The success of the reduction procedure, whether further reduction attempts were necessary, and findings from post-reduction control X-rays (radial height, radial tilt, and volar tilt) will be noted and evaluated by orthopedic physicians.
- Conditions
- Forearm Fracture, Radius Fractures, Ulnar Fracture
- Being tested
- Bupivacaine Hydrochloride, Ketamine
- Keywords
- Procedural sedation-analgesia, infraclavicular nerve block
- Medical subject headings
- Radius Fractures, Ulna Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine HydrochlorideDrug
Also called Infraclavicular nerve block (ICB)
After preparing the infraclavicular block site, a 22-gauge needle, guided by ultrasound, will be placed in the 6-7 o'clock position in the same plane as the ultrasound probe. Subsequently, lateral, medial, and posterior cords described as hypoechoic nerve fascicles within hyperechoic structures will be identified. Initially, 2 mL of saline will be administered to confirm proper spread. Once confirmed, 20 mL of 0.25% bupivacaine (prepared by diluting 10 mL of 0.5% bupivacaine with 10 mL of normal saline) will be injected in fractional doses with intermittent negative aspiration. Fifteen minutes after this procedure, anesthesia depth will be assessed using a cold-hot test, followed by reduction and application of the cast.
KetamineDrug
Also called procedural sedation-analgesia
Until the recovery period, patients will be closely monitored by an experienced doctor or nurse during sedation. Emergency equipment will be readily available in case of any complications. The following protocol will be used for procedural sedation-analgesia (PSA): Ketamine will be administered intravenously at a dose of 0.5-1 mg/kg. Patients with Numeric Rating Scale (NRS) scores above 5 may receive additional doses of 0.25-1 mg/kg, repeated every 5 to 10 minutes as needed.
| Study group | Role | What they receive |
|---|---|---|
| Group P | Active comparator | Reduction will be performed under procedural sedation analgesia (PSA) Receives: Drug: Ketamine |
| Group B | Active comparator | Reduction will be performed under ultrasound-guided infraclavicular nerve block (ICB). Receives: Drug: Bupivacaine Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of patients' pain levels according to the Numerical Rating Scale (NRS) after the applied protocols.
Pain levels at arrival, pre-reduction procedure, and post-reduction procedure will be recorded using the Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain).
Measured: 1. Pain level at the 1. minute upon presentation to the emergency room. 2. Pain level after the implementation of the protocols, i.e. 1 hour later. 3. Pain level 24 hours after the procedure.
Success of reduction following the applied protocols.
The success of the reduction procedure, whether further reduction attempts were necessary, and findings from post-reduction control X-rays (radial height, radial tilt, and volar tilt) will be noted and evaluated by orthopedic physicians.
Measured: An x-ray will be taken before the reduction process, i.e. at 10 minutes. An x-ray will be taken at 1 hour after the reduction process.
Evaluation of the need for additional rescue treatments during the procedure.
If NRS is above 5, as first-line rescue analgesia, tramadol 50 or 100 mg IV diluted in 100 mL normal saline will be administered over 15 minutes. If pain persists above NRS 5, second-line treatment with 50 mcg fentanyl diluted in 100 mL normal saline will be administered over 15 minutes.
Measured: Rescue analgesia will be administered if NRS is above 5 fifteen minutes after the protocols are applied.
Secondary outcomes (1)
Patient and practitioner satisfaction with the reduction procedure.
Patient and reduction practitioner satisfaction will be recorded using a 5-point Likert scale (1: very poor, 2: poor, 3: neutral, 4: good, 5: very good).
Measured: The satisfaction survey for both the patient and the reduction practitioner will be conducted 30 minutes after the reduction procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Jun 2024
- Primary completion1 Dec 2024
- Study completion15 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Forearm FractureStudies of the same condition, open and under way.
- More trials run by Ankara Etlik City HospitalThe 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
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Emine Sarcan, Ankara Etlik City Hospital
- Investigators
- Ahmet Burak Erdem, Study director, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06588907
- Sponsor's protocol ID
- ESarcan
- Status last verified
- Dec 2024
- First submitted
- 8 Jul 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fauteux-Lamarre E, Burstein B, Cheng A, Bretholz A. Reduced Length of Stay and Adverse Events Using Bier Block for Forearm Fracture Reduction in the Pediatric Emergency Department. Pediatr Emerg Care. 2019 Jan;35(1):58-62. doi: 10.1097/PEC.0000000000000963.
PubMed 27918376Tekin E, Aydin ME, Turgut MC, Karagoz S, Ates I, Ahiskalioglu EO. Can ultrasound-guided infraclavicular block be an alternative option for forearm reduction in the emergency department? A prospective randomized study. Clin Exp Emerg Med. 2021 Dec;8(4):307-313. doi: 10.15441/ceem.20.136. Epub 2021 Dec 31.
PubMed 35000358Kukreja P, Kofskey AM, Ransom E, McKenzie C, Feinstein J, Hudson J, Kalagara H. Comparison of Supraclavicular Regional Nerve Block Versus Infraclavicular Regional Nerve Block in Distal Radial Open Reduction and Internal Fixation: A Retrospective Case Series. Cureus. 2022 Apr 12;14(4):e24079. doi: 10.7759/cureus.24079. eCollection 2022 Apr.
PubMed 35573547Sarcan E, Erdem AB, Uysal SB, Duman E, Cebeci Z, Arik E. Pain management with ketamine procedural sedation and infraclavicular block for forearm fracture in the emergency department. Am J Emerg Med. 2025 Oct;96:256-263. doi: 10.1016/j.ajem.2025.07.012. Epub 2025 Jul 16.
PubMed 40694916
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Procedural Sedoanalgesia and Infraclavicular Nerve Blockade on Analgesia in Forearm Fractures in the Emergency Department
- ClinicalTrials.gov ID
- NCT06588907
- Acronym / sponsor ID
- ESarcan
- Conditions
- Forearm Fracture, Radius Fractures, Ulnar Fracture
- Keywords
- Procedural sedation-analgesia, infraclavicular nerve block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 15 Dec 2024 (actual)
- First posted
- 19 Sep 2024 (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 is to evaluate the success of reduction procedures and pain palliation in patients with forearm fractures undergoing reduction under procedural sedation-analgesia (PSA) and ultrasound (US)-guided infraclavicular nerve block (ICB) in the emergency department.
Detailed description
Forearm fractures are among the most frequent reasons for adults to visit the emergency department. These fractures cause significant pain both due to the fracture itself and during the reduction process. Pain management in emergency departments (ED) is crucial. Therefore, multimodal approaches are available to reduce or eliminate pain during the reduction process. The aim of this study is to evaluate the success and pain palliation of the reduction process with procedural sedation-analgesia (PSA) and with reduction under ultrasound (US)-guided infraclavicular nerve block (ICB) in patients with forearm fractures. The secondary aim is to compare patient comfort, physician comfort, side effects, length of stay in the emergency department, and the need for painkillers after discharge between these two procedures, and to identify the most suitable method. This study aims to contribute to practical applications in order to provide optimal pain control in patients with forearm fractures in emergency departments.
Patients' pain levels at arrival, pre-reduction procedure, and post-reduction procedure will be recorded using the Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain).The success of the reduction procedure, whether further reduction attempts were necessary, and findings from post-reduction control X-rays (radial height, radial tilt, and volar tilt) will be noted and evaluated by orthopedic physicians.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group P | Active comparator | Drug: KetamineReduction will be performed under procedural sedation analgesia (PSA) |
| Group B | Active comparator | Drug: Bupivacaine HydrochlorideReduction will be performed under ultrasound-guided infraclavicular nerve block (ICB). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 18 years and older,
- Diagnosed with forearm fracture using standard radiography,
- Hemodynamically stable individuals,
- Without vascular or nerve injury,
- Without infection in the skin or tissues where the needle will pass,
Key exclusion criteria (8 listed)
- Those with allergies to drugs used for sedoanalgesia and peripheral nerve blockade,
- Those who are hemodynamically unstable,
- Patients with ASA (American Society of Anesthesiologists) classification 3-4 will not be included in the group for whom PSA will be applied,
- Patients with coagulopathy, liver, or kidney failure,
- Patients with opioid, alcohol, or substance dependency,
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 |
|---|---|---|
| Bupivacaine HydrochlorideAlso: Infraclavicular nerve block (ICB)After preparing the infraclavicular block site, a 22-gauge needle, guided by ultrasound, will be placed in the 6-7 o'clock position in the same plane as the ultrasound probe. Subsequently, lateral, medial, and posterior cords described as hypoechoic nerve fascicles within hyperechoic structures will be identified. Initially, 2 mL of saline will be administered to confirm proper spread. Once confirmed, 20 mL of 0.25% bupivacaine (prepared by diluting 10 mL of 0.5% bupivacaine with 10 mL of normal saline) will be injected in fractional doses with intermittent negative aspiration. Fifteen minutes after this procedure, anesthesia depth will be assessed using a cold-hot test, followed by reduction and application of the cast. | Drug | Group B |
| KetamineAlso: procedural sedation-analgesiaUntil the recovery period, patients will be closely monitored by an experienced doctor or nurse during sedation. Emergency equipment will be readily available in case of any complications. The following protocol will be used for procedural sedation-analgesia (PSA): Ketamine will be administered intravenously at a dose of 0.5-1 mg/kg. Patients with Numeric Rating Scale (NRS) scores above 5 may receive additional doses of 0.25-1 mg/kg, repeated every 5 to 10 minutes as needed. | Drug | Group P |
Primary outcome
Evaluation of patients' pain levels according to the Numerical Rating Scale (NRS) after the applied protocols.
Time frame: 1. Pain level at the 1. minute upon presentation to the emergency room. 2. Pain level after the implementation of the protocols, i.e. 1 hour later. 3. Pain level 24 hours after the procedure.
Pain levels at arrival, pre-reduction procedure, and post-reduction procedure will be recorded using the Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain).
Success of reduction following the applied protocols.
Time frame: An x-ray will be taken before the reduction process, i.e. at 10 minutes. An x-ray will be taken at 1 hour after the reduction process.
The success of the reduction procedure, whether further reduction attempts were necessary, and findings from post-reduction control X-rays (radial height, radial tilt, and volar tilt) will be noted and evaluated by orthopedic physicians.
Evaluation of the need for additional rescue treatments during the procedure.
Time frame: Rescue analgesia will be administered if NRS is above 5 fifteen minutes after the protocols are applied.
If NRS is above 5, as first-line rescue analgesia, tramadol 50 or 100 mg IV diluted in 100 mL normal saline will be administered over 15 minutes. If pain persists above NRS 5, second-line treatment with 50 mcg fentanyl diluted in 100 mL normal saline will be administered over 15 minutes.
1 secondary outcome
Patient and practitioner satisfaction with the reduction procedure.
Time frame: The satisfaction survey for both the patient and the reduction practitioner will be conducted 30 minutes after the reduction procedure.
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 27 Dec 2024.
- Background: PubMed 27918376Fauteux-Lamarre E, Burstein B, Cheng A, Bretholz A. Reduced Length of Stay and Adverse Events Using Bier Block for Forearm Fracture Reduction in the Pediatric Emergency Department. Pediatr Emerg Care. 2019 Jan;35(1):58-62. doi: 10.1097/PEC.0000000000000963.
- Results publication: PubMed 35000358Tekin E, Aydin ME, Turgut MC, Karagoz S, Ates I, Ahiskalioglu EO. Can ultrasound-guided infraclavicular block be an alternative option for forearm reduction in the emergency department? A prospective randomized study. Clin Exp Emerg Med. 2021 Dec;8(4):307-313. doi: 10.15441/ceem.20.136. Epub 2021 Dec 31.
- Results publication: PubMed 35573547Kukreja P, Kofskey AM, Ransom E, McKenzie C, Feinstein J, Hudson J, Kalagara H. Comparison of Supraclavicular Regional Nerve Block Versus Infraclavicular Regional Nerve Block in Distal Radial Open Reduction and Internal Fixation: A Retrospective Case Series. Cureus. 2022 Apr 12;14(4):e24079. doi: 10.7759/cureus.24079. eCollection 2022 Apr.
- Derived from this study: PubMed 40694916Sarcan E, Erdem AB, Uysal SB, Duman E, Cebeci Z, Arik E. Pain management with ketamine procedural sedation and infraclavicular block for forearm fracture in the emergency department. Am J Emerg Med. 2025 Oct;96:256-263. doi: 10.1016/j.ajem.2025.07.012. Epub 2025 Jul 16.
Related trials for Forearm Fracture
Active, not recruiting
Treatment of Olecranon Fractures in the Elderly
Olecranon Fracture
Recruiting
This is a Study to Find Out Whether Surgery Using a Metal Plate to Fix a Broken Elbow in Older Adults Leads to Better Recovery and Arm Function Compared to Non-surgical Treatment
Olecranon Fracture
Recruiting
The With Or Without Olecranon K-wires Trial
Olecranon Fracture
RecruitingObservational study
Radiological Criteria for Instability in Distal Radius Fractures
Distal Radius Fractures
Recruiting
Evaluation of Diaphragmatic Function After Interscalene Block With Liposomal Bupivacaine
Diaphragmatic Function, Metacarpal Fracture
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.
Ahmet Burak Erdem study director
Ankara Etlik City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bupivacaine Hydrochloride and Ketamine in people with Forearm Fracture and Radius Fractures, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
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 6 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: finished, as of the sponsor's last update on 27 Dec 2024. 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 Turkey (Türkiye). 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?
Evaluation of patients' pain levels according to the Numerical Rating Scale (NRS) after the applied protocols. (time frame: 1. Pain level at the 1. minute upon presentation to the emergency room. 2. Pain level after the implementation of the protocols, i.e. 1 hour later. 3. Pain level 24 hours after the procedure.). The study lists 3 primary outcomes in all. 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 NCT06588907, which also lists 4 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 27 Dec 2024.