Distal Radius FracturePhase 2NCT03349216
Bier's Block Versus Systemic Analgesia
A Phase 2 study testing Intravenous Regional Anesthesia and Systemic Analgesia in people with Distal Radius Fracture, run by Isfahan University of Medical Sciences at 1 site in Iran.
Trial summary
Background: There are three methods for procedural sedation in upper extremity traumas; systemic, regional and local anesthesia. There is controversy in the literature regarding the method of choice for this purpose. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Distal Radius Fracture
- What is being tested?
- Intravenous Regional Anesthesia and Systemic Analgesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteIran
- Study dates
- 20 Oct 2017to Apr 2018
- Phase
- Phase 2
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- All adult patients (aged 18 or more) with upper extremity trauma who need procedural analgesia
Who cannot join
- Patients with a history of seizure
- Known allergy to analgesic substances
- Sickle cell anemia,
- Peripheral vascular disease and arteriovenous fistula
- Infection in upper extremities
- Patients who need emergent intervention/s that last more than one hour are also excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Intravenous Regional Anesthesia ( Bier's Block) and Systemic Analgesia for Upper Extremity Procedures in the Emergency Department of Al-Zahra University Hospital
Background: There are three methods for procedural sedation in upper extremity traumas; systemic, regional and local anesthesia. There is controversy in the literature regarding the method of choice for this purpose.
Objectives: The aim of this study was to compare conscious sedation and Bier's block methods for pain reduction in upper extremity trauma patients.
Read more
Patients and Methods: This was a randomized clinical trial. Patients were randomly allocated to either the Bier's block or the conscious sedation group. Pain reduction was assessed by a numerical rating scale; patients, surgeons and physicians responsible for analgesia satisfaction were assessed using a five-point Likert scale.
In this study, we aimed to compare the effectiveness, complications, duration, hemodynamic stability and patient and physician satisfaction between systemic analgesia and Bier's block method performed at the emergency department.
Read the detailed description
Patients and Methods
Study Design
This is a randomized clinical trial to be conducted at two tertiary health care centers, with census of 102000 and 60000 visits per year, during years 2017 and 2018. The study design has been approved by ethics committee of the university. Informed consents will be obtained from patients. And patients who refuse to participate in the study are excluded from the study and will receive analgesia based on the physician responsible for analgesia preference.
Population
All adult patients (aged 18 or more) with upper extremity trauma who need procedural analgesia in the ED are included in this study. Patients with a history of seizure, known allergy to analgesic substances, sickle cell anemia, peripheral vascular disease and arteriovenous fistula or infection in upper extremities are excluded from the study. Patients who need emergent intervention/s that last more than one hour are also excluded from the study. Randomization is done using sealed envelopes containing computer-generated block random allocation numbers.
Intervention
After introduction of the protocol of Bier's block (using 1.5 mg/kg of 0.5% lidocaine) or systemic analgesia (using ketamine 1.5 mg/kg), patients underwent the necessary procedure. Physicians who were responsible for the analgesia, had authority to change the method of analgesia in each group, if necessary.
Measurements
Patient's age, sex, site and type of injury, vital signs and pain score using the Numerical Rating Scale (NRS) will be recorded before the introduction of analgesia. Patient's vital signs are documented at the end of the procedure. Satisfaction of the patient, surgeon and physician responsible for analgesia for the applied analgesic method is obtained before discharge from the ED operating room. Patients also score their level of pain before discharge and their vital signs are recorded at another instance. Time of initiation of analgesia, initiation of procedure, end of procedure, and gaining consciousness in systemic analgesia group and time of discharge from ED operating room are documented and patients will be discharged from the ED operating room when eligible.
- Conditions
- Distal Radius Fracture
- Being tested
- Intravenous Regional Anesthesia, Systemic Analgesia
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous Regional AnesthesiaProcedure or surgery
Also called Bier's Block
in this research patients will receive intravenous regional anesthesia as infusion of mini dose (that is 1.5 mg/kg ) lidocaine 0.5% and immediately after procedure their torniquettes (A.T.S. 2000, Zimmer, Inc., Bloomfield, CN) will be deflated (hence named Rapid MiniBier's block). the pain score will be assessed by NRS system before during and after the procedure.
Systemic AnalgesiaDrug
Also called Conscious Sedation
in this group the patients will receive ketamine 1-2 mg/kg IV slow ( Bioniche,Ireland Ketamine Hydrochloride 500mg/10cc)and titrated to effect. again here the pain score will be assessed before procedure and after the procedure every 5 minutes until 30 minutes by NRS ( Numerical Rating Score)
| Study group | Role | What they receive |
|---|---|---|
| Intravenous regional Analgesia | Experimental | in this arm patients will receive intravenous regional anesthesia as infusion of mini dose (that is 1.5 mg/kg ) lidocaine 0.5% and immediately after procedure their torniquettes will be deflated (hence named Rapid MiniBier's block). Receives: Procedure: Intravenous Regional Anesthesia |
| Systemic Analgesia | Experimental | In this arm patients will receive ketamine 1-2 mg/kg IV slow as a systemic analgesia. ketamine as a PCP derivative has both hypnotic and analgesic effects. Receives: Drug: Systemic Analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain score
pain score assessed as numerical analogue score (NRS) with 1 for minimum and 10 for the maximum pain experienced by patient. A decrease of at least 13 millimeter will be considered as statistically meaningful.
Measured: 30 minutes since the beginning of procedure
Secondary outcomes (1)
Complications
Seizure
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2017
- Study start20 Oct 2017
- Primary completionJan 2018 (estimated)
- Study completionApr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Distal Radius FractureStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Bier's Block with Lidocaine versus Conscous Sedation with ketamine
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isfahan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehdi Nasr Isfahani, Isfahan University of Medical Sciences
- Investigators
- Mehdi Nasr Isfahani, M.D., Principal investigator, Isfahan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03349216
- Sponsor's protocol ID
- 395608
- Status last verified
- Nov 2017
- First submitted
- 11 Nov 2017
- Last updated
- 21 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Isfahani MN, Naseh K, Golshani K. Mini-dose Bier's block vs systemic analgesia in distal radius fractures: a promising reduction in emergency department throughput time. Pain Manag. 2023 Aug;13(8):433-443. doi: 10.2217/pmt-2023-0030. Epub 2023 Sep 18.
PubMed 37718930
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intravenous Regional Anesthesia ( Bier's Block) and Systemic Analgesia for Upper Extremity Procedures in the Emergency Department of Al-Zahra University Hospital
- ClinicalTrials.gov ID
- NCT03349216
- Acronym / sponsor ID
- 395608
- Conditions
- Distal Radius Fracture
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Study start
- 20 Oct 2017 (actual)
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 21 Nov 2017 (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.
Background: There are three methods for procedural sedation in upper extremity traumas; systemic, regional and local anesthesia. There is controversy in the literature regarding the method of choice for this purpose.
Objectives: The aim of this study was to compare conscious sedation and Bier's block methods for pain reduction in upper extremity trauma patients.
Patients and Methods: This was a randomized clinical trial. Patients were randomly allocated to either the Bier's block or the conscious sedation group. Pain reduction was assessed by a numerical rating scale; patients, surgeons and physicians responsible for analgesia satisfaction were assessed using a five-point Likert scale.
In this study, we aimed to compare the effectiveness, complications, duration, hemodynamic stability and patient and physician satisfaction between systemic analgesia and Bier's block method performed at the emergency department.
Detailed description
Patients and Methods
Study Design
This is a randomized clinical trial to be conducted at two tertiary health care centers, with census of 102000 and 60000 visits per year, during years 2017 and 2018. The study design has been approved by ethics committee of the university. Informed consents will be obtained from patients. And patients who refuse to participate in the study are excluded from the study and will receive analgesia based on the physician responsible for analgesia preference.
Population
All adult patients (aged 18 or more) with upper extremity trauma who need procedural analgesia in the ED are included in this study. Patients with a history of seizure, known allergy to analgesic substances, sickle cell anemia, peripheral vascular disease and arteriovenous fistula or infection in upper extremities are excluded from the study. Patients who need emergent intervention/s that last more than one hour are also excluded from the study. Randomization is done using sealed envelopes containing computer-generated block random allocation numbers.
Intervention
After introduction of the protocol of Bier's block (using 1.5 mg/kg of 0.5% lidocaine) or systemic analgesia (using ketamine 1.5 mg/kg), patients underwent the necessary procedure. Physicians who were responsible for the analgesia, had authority to change the method of analgesia in each group, if necessary.
Measurements
Patient's age, sex, site and type of injury, vital signs and pain score using the Numerical Rating Scale (NRS) will be recorded before the introduction of analgesia. Patient's vital signs are documented at the end of the procedure. Satisfaction of the patient, surgeon and physician responsible for analgesia for the applied analgesic method is obtained before discharge from the ED operating room. Patients also score their level of pain before discharge and their vital signs are recorded at another instance. Time of initiation of analgesia, initiation of procedure, end of procedure, and gaining consciousness in systemic analgesia group and time of discharge from ED operating room are documented and patients will be discharged from the ED operating room when eligible.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Bier's Block with Lidocaine versus Conscous Sedation with ketamine
| Arm | Type | Receives |
|---|---|---|
| Intravenous regional Analgesia | Experimental | Procedure: Intravenous Regional Anesthesiain this arm patients will receive intravenous regional anesthesia as infusion of mini dose (that is 1.5 mg/kg ) lidocaine 0.5% and immediately after procedure their torniquettes will be deflated (hence named Rapid MiniBier's block). |
| Systemic Analgesia | Experimental | Drug: Systemic AnalgesiaIn this arm patients will receive ketamine 1-2 mg/kg IV slow as a systemic analgesia. ketamine as a PCP derivative has both hypnotic and analgesic effects. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All adult patients (aged 18 or more) with upper extremity trauma who need procedural analgesia
Key exclusion criteria (6 listed)
- Patients with a history of seizure
- Known allergy to analgesic substances
- Sickle cell anemia,
- Peripheral vascular disease and arteriovenous fistula
- Infection in upper extremities
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 |
|---|---|---|
| Intravenous Regional AnesthesiaAlso: Bier's Blockin this research patients will receive intravenous regional anesthesia as infusion of mini dose (that is 1.5 mg/kg ) lidocaine 0.5% and immediately after procedure their torniquettes (A.T.S. 2000, Zimmer, Inc., Bloomfield, CN) will be deflated (hence named Rapid MiniBier's block). the pain score will be assessed by NRS system before during and after the procedure. | Procedure or surgery | Intravenous regional Analgesia |
| Systemic AnalgesiaAlso: Conscious Sedationin this group the patients will receive ketamine 1-2 mg/kg IV slow ( Bioniche,Ireland Ketamine Hydrochloride 500mg/10cc)and titrated to effect. again here the pain score will be assessed before procedure and after the procedure every 5 minutes until 30 minutes by NRS ( Numerical Rating Score) | Drug | Systemic Analgesia |
Primary outcome
pain score
Time frame: 30 minutes since the beginning of procedure
pain score assessed as numerical analogue score (NRS) with 1 for minimum and 10 for the maximum pain experienced by patient. A decrease of at least 13 millimeter will be considered as statistically meaningful.
1 secondary outcome
Complications
Time frame: 30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2017.
- Derived from this study: PubMed 37718930Isfahani MN, Naseh K, Golshani K. Mini-dose Bier's block vs systemic analgesia in distal radius fractures: a promising reduction in emergency department throughput time. Pain Manag. 2023 Aug;13(8):433-443. doi: 10.2217/pmt-2023-0030. Epub 2023 Sep 18.
- Individual participant dataSharing planned: Undecided
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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.
Mehdi Nasr Isfahani, M.D. principal investigator
Isfahan University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intravenous Regional Anesthesia and Systemic Analgesia in people with Distal Radius Fracture, run by Isfahan University of Medical Sciences at 1 site in Iran.
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 1 inclusion and 6 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 21 Nov 2017. 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 Iran. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
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?
pain score (time frame: 30 minutes since the beginning of procedure). 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 NCT03349216, which also lists 1 linked publication.
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 21 Nov 2017.