Effect IncreasedPhase 1NCT03346993
Can Latency of Action in Infraclavicular Brachial Plexus Block be Shortened With Warmed Bupivacaine?
A Phase 1 study testing Bupivacaine Hydrochloride 5 MG/ML in people with Effect Increased, run by Erzurum Palandöken State Hospital at 1 site in Turkey (Türkiye).
Trial summary
Brachial plexus blocks have some advantages, but also have some disadvantages as well. As with all nerve blocks, having to wait sometime for an effective block, sometimes failure to achieve an adequate block and possible requirement for isolated nerve block, having to wait a long time for resolution of the block, and… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Effect Increased
- What is being tested?
- Bupivacaine Hydrochloride 5 MG/ML
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2016to 1 Jan 2017
- Phase
- Phase 1
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged between 18 and 65 years
- American society of anesthesiologists (ASA) physical status classification systems I/II and III
- Candidate for surgical operations on any of the forearm, wrist and hand regions.
Who cannot join
- Neurological and neuromuscular disorders,
- Psychiatric problems
- Cardiopulmonary diseases
- Coagulopathy
- Infections
- Sllergy to local anesthetic agents.
Trial locations and contacts
1 site in 1 country.
About this study
Brachial plexus blocks have some advantages, but also have some disadvantages as well. As with all nerve blocks, having to wait sometime for an effective block, sometimes failure to achieve an adequate block and possible requirement for isolated nerve block, having to wait a long time for resolution of the block, and immobilization of the extremity for some time can be seen as handicaps for brachial plexus block as well. In the present study, Study was aimed to compare the effects of bupivacaine warmed to body temperature and kept at room temperature on the onset time of ultrasound guided infraclavicular brachial plexus block.
Read the detailed description
The study design was approved by the locale ethics committee. This double-blinded, randomized, controlled clinical trial recruited 60 patients aged between 18 and 65 years with the American society of anesthesiologists (ASA) physical status classification systems I/II and III who were candidated for surgical operations on any of the forearm, wrist and hand regions. All the participants were asked to sign an informed consent form after having been provided with details of the aim and proceedings of the study.
Patients were excluded from the study if they had a neurological and neuromuscular disorders, psychiatric problems, cardiopulmonary diseases, coagulopathy, infections or allergy to local anesthetic agents.
The patients were equally and randomly distributed into a 24C° 20 ml 0,5% bupivacaine group (Group 1), and 37C° 20 ml 0,5% bupivacaine group (Group 2) via closed envelope technique. All the participants were premedicated with 0.05 mg/kg of intravenous midazolam and monitored routinely before attempting nerve block.
Bupivacaine stored for at least 2 hours in a bain-marie (Memmert Waterbath WNB7, Germany) at 38˚C (regular temperature calibration was made) for Group 2.
The block process was accomplished by an anesthesiologist, who was blind to the temperature of bupivacaine and local anesthetic agent was administered by different anesthesiologist.
At the end of the ICBP block, an anesthetist blinded to the technique evaluated sensory and motor block in every minutes between 5th and 30th minutes as follows. The innervated areas (each dermatome) was evaluated using a pinprick test. The motor block was evaluated by bromage modified scale in every minutes between 10th and 30th minutes. Anxious patients were administered additional midazolam. Subjects refusing awake surgery were administered a propofol infusion with supplemental oxygen as necessary.
- Conditions
- Effect Increased
- Being tested
- Bupivacaine Hydrochloride 5 MG/ML
- Keywords
- Bupivacaine, Brachial Plexus Block, Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine Hydrochloride 5 MG/MLDrug
Ultrasound guided infraclavicular brachial plexus block with warmed bupivacaine
| Study group | Role | What they receive |
|---|---|---|
| 24C° 0,5% bupivacaine group | Experimental | 24C° 0,5% bupivacaine group will be performed USG guided infraclavicular block with 24C° 20 ml 0,5% bupivacaine Receives: Drug: Bupivacaine Hydrochloride 5 MG/ML |
| 37C° 0,5% bupivacaine group | Experimental | 37C° 0,5% bupivacaine group will be performed USG guided infraclavicular block with 37C° 20 ml 0,5% bupivacaine Receives: Drug: Bupivacaine Hydrochloride 5 MG/ML |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate sensory block's onset time
Pain was evaluated by pinprick test (yes-there is a pain/ no-there is no pain)
Measured: 30 minutes after Brachial Plexus Block
Secondary outcomes (1)
Evaluate motor block's onset times
Motion on distal arm was evaluated by bromage scale (0- full flexion of distal arm, 3-unable to move distal arm)
Measured: 30 minutes after Brachial Plexus Block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2017
- Study start1 Jul 2016
- Primary completion1 Jul 2016
- Study completion1 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect IncreasedStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erzurum Palandöken State Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Erkan Cem ÇELİK, Erzurum Palandöken State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03346993
- Sponsor's protocol ID
- Palandöken State Hospital
- Status last verified
- Nov 2017
- First submitted
- 8 Nov 2017
- Last updated
- 20 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Latency of Action in Infraclavicular Brachial Plexus Block be Shortened With Warmed Bupivacaine?
- ClinicalTrials.gov ID
- NCT03346993
- Acronym / sponsor ID
- Palandöken State Hospital
- Conditions
- Effect Increased
- Keywords
- Bupivacaine, Brachial Plexus Block, Ultrasound
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Erzurum Palandöken State HospitalOther government
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 1 Jul 2016 (actual)
- Study completion
- 1 Jan 2017 (actual)
- First posted
- 20 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.
Brachial plexus blocks have some advantages, but also have some disadvantages as well. As with all nerve blocks, having to wait sometime for an effective block, sometimes failure to achieve an adequate block and possible requirement for isolated nerve block, having to wait a long time for resolution of the block, and immobilization of the extremity for some time can be seen as handicaps for brachial plexus block as well. In the present study, Study was aimed to compare the effects of bupivacaine warmed to body temperature and kept at room temperature on the onset time of ultrasound guided infraclavicular brachial plexus block.
Detailed description
The study design was approved by the locale ethics committee. This double-blinded, randomized, controlled clinical trial recruited 60 patients aged between 18 and 65 years with the American society of anesthesiologists (ASA) physical status classification systems I/II and III who were candidated for surgical operations on any of the forearm, wrist and hand regions. All the participants were asked to sign an informed consent form after having been provided with details of the aim and proceedings of the study.
Patients were excluded from the study if they had a neurological and neuromuscular disorders, psychiatric problems, cardiopulmonary diseases, coagulopathy, infections or allergy to local anesthetic agents.
The patients were equally and randomly distributed into a 24C° 20 ml 0,5% bupivacaine group (Group 1), and 37C° 20 ml 0,5% bupivacaine group (Group 2) via closed envelope technique. All the participants were premedicated with 0.05 mg/kg of intravenous midazolam and monitored routinely before attempting nerve block.
Bupivacaine stored for at least 2 hours in a bain-marie (Memmert Waterbath WNB7, Germany) at 38˚C (regular temperature calibration was made) for Group 2.
The block process was accomplished by an anesthesiologist, who was blind to the temperature of bupivacaine and local anesthetic agent was administered by different anesthesiologist.
At the end of the ICBP block, an anesthetist blinded to the technique evaluated sensory and motor block in every minutes between 5th and 30th minutes as follows. The innervated areas (each dermatome) was evaluated using a pinprick test. The motor block was evaluated by bromage modified scale in every minutes between 10th and 30th minutes. Anxious patients were administered additional midazolam. Subjects refusing awake surgery were administered a propofol infusion with supplemental oxygen as necessary.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 24C° 0,5% bupivacaine group | Experimental | Drug: Bupivacaine Hydrochloride 5 MG/ML24C° 0,5% bupivacaine group will be performed USG guided infraclavicular block with 24C° 20 ml 0,5% bupivacaine |
| 37C° 0,5% bupivacaine group | Experimental | Drug: Bupivacaine Hydrochloride 5 MG/ML37C° 0,5% bupivacaine group will be performed USG guided infraclavicular block with 37C° 20 ml 0,5% bupivacaine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged between 18 and 65 years
- American society of anesthesiologists (ASA) physical status classification systems I/II and III
- Candidate for surgical operations on any of the forearm, wrist and hand regions.
Key exclusion criteria (6 listed)
- Neurological and neuromuscular disorders,
- Psychiatric problems
- Cardiopulmonary diseases
- Coagulopathy
- Infections
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 Hydrochloride 5 MG/MLUltrasound guided infraclavicular brachial plexus block with warmed bupivacaine | Drug | 24C° 0,5% bupivacaine group, 37C° 0,5% bupivacaine group |
Primary outcome
Evaluate sensory block's onset time
Time frame: 30 minutes after Brachial Plexus Block
Pain was evaluated by pinprick test (yes-there is a pain/ no-there is no pain)
1 secondary outcome
Evaluate motor block's onset times
Time frame: 30 minutes after Brachial Plexus Block
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 20 Nov 2017.
- 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.
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 Phase 1 study testing Bupivacaine Hydrochloride 5 MG/ML in people with Effect Increased, run by Erzurum Palandöken State 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 3 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: finished, as of the sponsor's last update on 20 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 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Evaluate sensory block's onset time (time frame: 30 minutes after Brachial Plexus Block). 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 20 Nov 2017.