PainNCT03377907
Pain Alleviation of Forearm Fractures
A study testing ketamine in hematoma block, ketamine in local intravenous anesthesia and Lidocaine Hydrochloride in people with Pain and Forearm Fracture, run by Assiut University at 1 site in Egypt.
Trial summary
fractures of upper limb induce much pain . A lot of modalities are available to alleviate pain. fracture hematoma block, and intravenous regional anesthesia seem to be cost effective and attractive options Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Pain, Forearm Fracture
- What is being tested?
- ketamine in hematoma block, ketamine in local intravenous anesthesia and Lidocaine Hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2018to 1 Dec 2018
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- All patients aged more than 18 years old.
- American Society of Anesthesiologists (ASA) physical status I or II.
- Patients scheduled for closed fracture of distal upper extremity within 7 days, requiring open or closed reduction and internal fixation.
- Patients scheduled for procedure lasting less than 90 minutes.
Who cannot join
- Patients having cardiovascular co-morbidities.
- Compound or contaminated fracture.
- Peripheral vascular disease, sickle cell disease or coagulation disorders.
- Allergy to the local anesthetics or to the drugs used in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Perioperative Pain Alleviation of Forearm Fractures Using a Combination of Hematoma Block and Intravenous Regional Anesthesia by Ketamine and Lidocaine
fractures of upper limb induce much pain . A lot of modalities are available to alleviate pain. fracture hematoma block, and intravenous regional anesthesia seem to be cost effective and attractive options
Read the detailed description
Fractures of the forearm are extremely common, Pain relief is of utmost importance in forearm fractures which may need manipulation immediately for reduction followed by operative intervention
The characteristic features of ideal analgesia during reduction are determined by safety, simplicity, affectivity and costs. Giventhe logistic difficulty of providing such anesthesia to such large number of patients simpler alternatives to conventional anesthesia have been tried. Hematoma Block alone, Hematoma Block with sedation, Bier's Block (Intravenous regional anesthesia), regional nerve blocks, sedation have been compared to general anesthesia to evaluate the efficacy, effectiveness, safety in treating such patients
Amongst various techniques, HB and IVRA are attractive options. However, while HB has been demonstrated to be safe simple and has been used effectively for treatment of radius fractures in ER and for immediate pain relief it doesn't provide muscular relaxation and may not be sufficient for any operative intervention
IVRA is suitable for operations of the distal extremities, in situations where it is safe and easy to apply an occlusive tourniquet. The primary advantages of IVRA are its simplicity, reliability, and cost-effectiveness. . It is a regional anesthetic technique that is easy to perform, with success rates varying between 94% and 98%.For these reasons, it remains a popular choice among anesthesiologists.
A combination of blocks is usually done to overcome the deficiencies of individual blocks and to improve operating conditions or to prolong post operative analgesia. However the use of dual technique of IVRA and HB with local anesthetic only offered near absence of post operative analgesia
Lidocaine is the most frequently used LA for IVRA and HB
Different agents have been used as additive to local anesthetic for IVRA including phencyclidines, non-steroidal anti inflammatory drugs, opioids, and muscle relaxants. Ketamine is an effective anesthetic agent for IVRA at concentrations between 0.3% and 0.5%.it improves quality of anesthesia and peri operative analgesia without causing side effects
Ketamine, a phenyl-piper dine derivative, was first synthesized in the early 1960 as an IV anesthetic agent. At sub anesthetic doses, ketamine exerts a noncompetitive blockade of N -methyl aspartate (NMDA) receptors. NMDA receptors play a major role in synaptic plasticity and are specifically implicated in central nervous system facilitation of pain processing. NMDA receptor antagonists have been implicated in perioperative pain management. Ketamine also has local anesthetic qualities, which have been studied as a sole agent for IVRA. In addition to spinal cord NMDA receptors, NMDA receptors have also been identified on peripheral unmyelinated sensory axons. This can explain why ketamine as an NMDA receptor antagonist was able to attenuate the tourniquet pain.
- Conditions
- Pain, Forearm Fracture
- Being tested
- ketamine in hematoma block, ketamine in local intravenous anesthesia, Lidocaine Hydrochloride
- Keywords
- IVRA, hematoma block
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ketamine in hematoma blockDrug
ketamine used in local hematoma block only
ketamine in local intravenous anesthesiaDrug
ketamine will be used with lidocaine in local intravenous anesthesia
Lidocaine HydrochlorideDrug
2.5 mg/kg of lidocaine 2% in intravenous regional anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Ketamine in hematoma block | Active comparator | Ketamine used in hematoma block Receives: Drug: ketamine in hematoma block |
| ketamine intravenous anesthesia | Active comparator | ketamine used in local intravenous anesthesia Receives: Drug: ketamine in local intravenous anesthesia |
| lidocaine intravenous anesthesia | Active comparator | 2.5 mg/kg of lidocaine 2% diluted with saline to a total volume of 40 ml. Receives: Drug: Lidocaine Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain assessment
pain will be assessed by numerical rating scale
Measured: 24 hours
Secondary outcomes (1)
analgesia requirement
time of first analgesia requirement
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2017
- Study start1 Feb 2018
- Primary completion1 Nov 2018
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Assiut 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, Care provider
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed mamdouh mohammed mahmoud, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03377907
- Sponsor's protocol ID
- IRB17100203
- Status last verified
- Feb 2019
- First submitted
- 12 Dec 2017
- Last updated
- 28 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Pain Alleviation of Forearm Fractures Using a Combination of Hematoma Block and Intravenous Regional Anesthesia by Ketamine and Lidocaine
- ClinicalTrials.gov ID
- NCT03377907
- Acronym / sponsor ID
- IRB17100203
- Conditions
- Pain, Forearm Fracture
- Keywords
- IVRA, hematoma block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 Nov 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 19 Dec 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.
fractures of upper limb induce much pain . A lot of modalities are available to alleviate pain. fracture hematoma block, and intravenous regional anesthesia seem to be cost effective and attractive options
Detailed description
Fractures of the forearm are extremely common, Pain relief is of utmost importance in forearm fractures which may need manipulation immediately for reduction followed by operative intervention
The characteristic features of ideal analgesia during reduction are determined by safety, simplicity, affectivity and costs. Giventhe logistic difficulty of providing such anesthesia to such large number of patients simpler alternatives to conventional anesthesia have been tried. Hematoma Block alone, Hematoma Block with sedation, Bier's Block (Intravenous regional anesthesia), regional nerve blocks, sedation have been compared to general anesthesia to evaluate the efficacy, effectiveness, safety in treating such patients
Amongst various techniques, HB and IVRA are attractive options. However, while HB has been demonstrated to be safe simple and has been used effectively for treatment of radius fractures in ER and for immediate pain relief it doesn't provide muscular relaxation and may not be sufficient for any operative intervention
IVRA is suitable for operations of the distal extremities, in situations where it is safe and easy to apply an occlusive tourniquet. The primary advantages of IVRA are its simplicity, reliability, and cost-effectiveness. . It is a regional anesthetic technique that is easy to perform, with success rates varying between 94% and 98%.For these reasons, it remains a popular choice among anesthesiologists.
A combination of blocks is usually done to overcome the deficiencies of individual blocks and to improve operating conditions or to prolong post operative analgesia. However the use of dual technique of IVRA and HB with local anesthetic only offered near absence of post operative analgesia
Lidocaine is the most frequently used LA for IVRA and HB
Different agents have been used as additive to local anesthetic for IVRA including phencyclidines, non-steroidal anti inflammatory drugs, opioids, and muscle relaxants. Ketamine is an effective anesthetic agent for IVRA at concentrations between 0.3% and 0.5%.it improves quality of anesthesia and peri operative analgesia without causing side effects
Ketamine, a phenyl-piper dine derivative, was first synthesized in the early 1960 as an IV anesthetic agent. At sub anesthetic doses, ketamine exerts a noncompetitive blockade of N -methyl aspartate (NMDA) receptors. NMDA receptors play a major role in synaptic plasticity and are specifically implicated in central nervous system facilitation of pain processing. NMDA receptor antagonists have been implicated in perioperative pain management. Ketamine also has local anesthetic qualities, which have been studied as a sole agent for IVRA. In addition to spinal cord NMDA receptors, NMDA receptors have also been identified on peripheral unmyelinated sensory axons. This can explain why ketamine as an NMDA receptor antagonist was able to attenuate the tourniquet pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ketamine in hematoma block | Active comparator | Drug: ketamine in hematoma blockKetamine used in hematoma block |
| ketamine intravenous anesthesia | Active comparator | Drug: ketamine in local intravenous anesthesiaketamine used in local intravenous anesthesia |
| lidocaine intravenous anesthesia | Active comparator | Drug: Lidocaine Hydrochloride2.5 mg/kg of lidocaine 2% diluted with saline to a total volume of 40 ml. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- All patients aged more than 18 years old.
- American Society of Anesthesiologists (ASA) physical status I or II.
- Patients scheduled for closed fracture of distal upper extremity within 7 days, requiring open or closed reduction and internal fixation.
- Patients scheduled for procedure lasting less than 90 minutes.
Key exclusion criteria (4 listed)
- Patients having cardiovascular co-morbidities.
- Compound or contaminated fracture.
- Peripheral vascular disease, sickle cell disease or coagulation disorders.
- Allergy to the local anesthetics or to the drugs used in the study.
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 |
|---|---|---|
| ketamine in hematoma blockketamine used in local hematoma block only | Drug | Ketamine in hematoma block |
| ketamine in local intravenous anesthesiaketamine will be used with lidocaine in local intravenous anesthesia | Drug | ketamine intravenous anesthesia |
| Lidocaine Hydrochloride2.5 mg/kg of lidocaine 2% in intravenous regional anesthesia | Drug | lidocaine intravenous anesthesia |
Primary outcome
pain assessment
Time frame: 24 hours
pain will be assessed by numerical rating scale
1 secondary outcome
analgesia requirement
Time frame: 24 hours
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 28 Feb 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ketamine in hematoma block, ketamine in local intravenous anesthesia and Lidocaine Hydrochloride in people with Pain and Forearm Fracture, run by Assiut 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 4 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 28 Feb 2019. 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?
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?
pain assessment (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Feb 2019.