Diabetes MellitusNCT03486535
Infraclavicular Block Properties in Diabetic Patients
An observational study of Diabetes Mellitus and Nerve Block Duration, run by Istanbul University at 2 sites in Turkey (Türkiye).
Trial summary
Background and objectives: The investigators are performing this study to explore whether the presence of diabetes mellitus (DM) will affect the outcomes of infraclavicular brachial plexus blocks (ICBs) in patients undergoing elbow, forearm and hand surgery. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Nerve Block Duration, Pain, Postoperative
- What is being tested?
- Infraclavicular Brachial Plexus Blocks
- How many people
- 60 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 20 Feb 2018to 31 Jan 2019
- Phase
- Observational
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for arm, elbow, forearm, and hand surgery.
Who may be able to join
- Patients scheduled for arm, elbow, forearm, and hand surgery American Society of Anesthesiologists (ASA) physical status I-IV No regional anesthesia contraindication
Who cannot join
- Type 1 DM, Type 2 DM patients with only 'diet-controlled' therapy Difficulty with understanding the block and follow-up instructions Significant neurologic disorders Psychiatric or cognitive disorders History of substance abuse Acute and/or chronic opioid use Local anaesthetic hypersensitivity or allergy
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Istanbul University, Medical Faculty of Istanbul
Istanbul, 34093
Metin Sabancı Baltalimanı Kemik Hastalıkları Training and Research Hospital
Istanbul, 34470
About this study
Official title: Ultrasound-Guided Infraclavicular Brachial Plexus Block Properties in Diabetic and Non-diabetic Patients: A Prospective Observational Study
Background and objectives: The investigators are performing this study to explore whether the presence of diabetes mellitus (DM) will affect the outcomes of infraclavicular brachial plexus blocks (ICBs) in patients undergoing elbow, forearm and hand surgery.
The primary hypothesis is that the sensory block duration will be delaying in diabetic patients.
Read more
Methods: Ethics committee approval has been obtained and after written informed consents, 60 patients are planning to be enrolled to the study. Diabetic patients will be included in Group DM and non-diabetics are included in Group NODM. All patients will receive ultrasound-guided ICBs with the mixture of 15 mL lidocaine 2% and 15 mL bupivacaine 0.5%. Our primary outcome is sensory block duration, and secondary outcomes are sensory and motor block onset times, motor block duration, time-to-first-pain (numeric rating scale (NRS)
≥4), postoperative NRS scores and rescue analgesic consumption (NRS) ≥4) through the postoperative first 2 days. All outcomes will be assessed by blind investigators.
Read the detailed description
Background and objectives: The impact of diabetes mellitus (DM) on the practice of peripheral nerve blocks need to be investigated on human models, besides animal researches. The investigators have been performing this study to explore whether the presence of DM will affect the outcomes of infraclavicular brachial plexus blocks (ICBs) in patients undergoing elbow, forearm, and hand surgery. The primary hypothesis is that the sensory block duration will be delaying in diabetic patients.
Methods: After obtaining ethics committee approval and written informed consent, 60 patients with American Society of Anesthesiologists (ASA) physical status I-IV and aged between 40 and 80 years are enrolled to the study. Diabetic patients will be included in Group DM and non-diabetics will be included in Group NODM. All patients will receive ultrasound-guided ICBs with the mixture of 15 mL lidocaine 2% and 15 mL bupivacaine 0.5%. Postoperatively, patients will be administered diclomec SR 75 mg IM first and if still needed tramadol 100 mg IV as rescue analgesics (numeric rating scale (NRS) is ≥4). Our primary outcome is sensory block duration, and secondary outcomes are sensory and motor block onset times, motor block duration, time-to-first-pain (numeric rating scale (NRS) ≥4), postoperative NRS scores, and rescue analgesic consumption through the postoperative first 2 days. All outcomes will be assessed by blind investigators.
- Conditions
- Diabetes Mellitus, Nerve Block Duration, Pain, Postoperative
- Being tested
- Infraclavicular Brachial Plexus Blocks
- Keywords
- Diabetes mellitus, Infraclavicular brachial plexus block, Block duration, Time-to-first pain, Postoperative analgesia
- Medical subject headings
- Diabetes Mellitus, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infraclavicular Brachial Plexus BlocksDrug
Also called Same interventions, drugs and concentrations
All patients will receive Infraclavicular Brachial Plexus Blocks with the mixture of lidocaine and bupivacaine. This is an observational study, because all patients will receive the same blocks with the same doses of the local anesthetics. The only difference between groups is including patients with or without Diabetes Mellitus diagnosis. The intervention is the same and these patients cannot be randomized. The aim is investigating the effect of this local anesthetic mixture in Diabetic patients.
Infraclavicular Brachial Plexus BlocksDrug
Also called Same interventions, drugs and concentrations
All patients will receive Infraclavicular Brachial Plexus Blocks with the mixture of lidocaine and bupivacaine. This is an observational study, because all patients will receive the same blocks with the same doses of the local anesthetics. The only difference between groups is including patients with or without Diabetes Mellitus diagnosis. The intervention is the same and these patients cannot be randomized. The aim is investigating the effect of this local anesthetic mixture in Nondiabetic patients.
| Study group | Role | What they receive |
|---|---|---|
| Diabetic patients | Diabetic patients will receive ultrasound-guided infraclavicular brachial plexus blocks (ICBs) with the mixture of 15 mL lidocaine 2% and 15 mL bupivacaine 0.5%. Receives: Drug: Infraclavicular Brachial Plexus Blocks | |
| Non-diabetic patients | Nondiabetic patients will receive ultrasound-guided infraclavicular brachial plexus blocks (ICBs) with the mixture of 15 mL lidocaine 2% and 15 mL bupivacaine 0.5%. Receives: Drug: Infraclavicular Brachial Plexus Blocks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensory block duration
Time interval between a successful block (0: full sensation, 1: less sensation, and 2: no sensation) (≥7/8) and the complete restoration of all the senses controlled by the radial, ulnar, median and musculocutaneous nerves (0/8)
Measured: 0-24 hours
Secondary outcomes (6)
Sensory block onset time
Physical examination with pin-prick test until the block onset (0: full sensation, 1: less sensation, and 2: no sensation) (≥7/8)
Measured: 0-30 minutes
Motor block onset time
Physical examination with modified Bromage scale until the block onset (0: normal motor function; 1: partial motor block, able to flex the elbow and move the fingers but unable to raise the extended arm; 2: almost complete motor block, unable to flex the elbow but able to move the fingers; and 3: complete motor block, unable to move the arm, elbow, or fingers) (≥9/12)
Measured: 0-30 minutes
Motor block duration
Time interval between a successful block (0: normal motor function; 1: partial motor block, able to flex the elbow and move the fingers but unable to raise the extended arm; 2: almost complete motor block, unable to flex the elbow but able to move the fingers; and 3: complete motor block, unable to move the arm, elbow, or fingers) (≥9/12) and the complete restoration of all motor responses controlled by the radial, ulnar, median and musculocutaneous nerves (0/12).
Measured: 0-24 hours
Time-to-first pain
Postoperative first pain (Numeric rating scale (NRS) ≥4) (0: no pain, 10: worst pain imaginable)
Measured: 0-48 hours
Pain (NRS) scores
Numeric rating scale (Numeric rating scale (NRS) ≥4) pain scores (0: no pain, 10: worst pain imaginable)
Measured: 0-48 hours
Rescue analgesic consumption
Used postoperatively if (Numeric rating scale (NRS) ≥4) (0: no pain, 10: worst pain imaginable)
Measured: 0-48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2018
- Study start20 Feb 2018
- Primary completion31 Jan 2019
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Istanbul 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emine Aysu Salviz, MD, Istanbul University
- Investigators
- Emine A Salviz, Principal investigator, Istanbul University, Medical Faculty of Istanbul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03486535
- Sponsor's protocol ID
- 2018/203
- Status last verified
- Mar 2018
- First submitted
- 27 Mar 2018
- Last updated
- 30 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Salviz EA, Onbasi S, Ozonur A, Orhan-Sungur M, Berkoz O, Tugrul KM. Comparison of Ultrasound-Guided Axillary Brachial Plexus Block Properties in Diabetic and Nondiabetic Patients: A Prospective Observational Study. J Hand Surg Am. 2017 Mar;42(3):190-197. doi: 10.1016/j.jhsa.2017.01.009.
PubMed 28259276Cuvillon P, Reubrecht V, Zoric L, Lemoine L, Belin M, Ducombs O, Birenbaum A, Riou B, Langeron O. Comparison of subgluteal sciatic nerve block duration in type 2 diabetic and non-diabetic patients. Br J Anaesth. 2013 May;110(5):823-30. doi: 10.1093/bja/aes496. Epub 2013 Jan 24.
PubMed 23348203
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-Guided Infraclavicular Brachial Plexus Block Properties in Diabetic and Non-diabetic Patients: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT03486535
- Acronym / sponsor ID
- 2018/203
- Conditions
- Diabetes Mellitus, Nerve Block Duration, Pain, Postoperative
- Keywords
- Diabetes mellitus, Infraclavicular brachial plexus block, Block duration, Time-to-first pain, Postoperative analgesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 20 Feb 2018 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 3 Apr 2018 (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 and objectives: The investigators are performing this study to explore whether the presence of diabetes mellitus (DM) will affect the outcomes of infraclavicular brachial plexus blocks (ICBs) in patients undergoing elbow, forearm and hand surgery.
The primary hypothesis is that the sensory block duration will be delaying in diabetic patients.
Methods: Ethics committee approval has been obtained and after written informed consents, 60 patients are planning to be enrolled to the study. Diabetic patients will be included in Group DM and non-diabetics are included in Group NODM. All patients will receive ultrasound-guided ICBs with the mixture of 15 mL lidocaine 2% and 15 mL bupivacaine 0.5%. Our primary outcome is sensory block duration, and secondary outcomes are sensory and motor block onset times, motor block duration, time-to-first-pain (numeric rating scale (NRS)
≥4), postoperative NRS scores and rescue analgesic consumption (NRS) ≥4) through the postoperative first 2 days. All outcomes will be assessed by blind investigators.
Detailed description
Background and objectives: The impact of diabetes mellitus (DM) on the practice of peripheral nerve blocks need to be investigated on human models, besides animal researches. The investigators have been performing this study to explore whether the presence of DM will affect the outcomes of infraclavicular brachial plexus blocks (ICBs) in patients undergoing elbow, forearm, and hand surgery. The primary hypothesis is that the sensory block duration will be delaying in diabetic patients.
Methods: After obtaining ethics committee approval and written informed consent, 60 patients with American Society of Anesthesiologists (ASA) physical status I-IV and aged between 40 and 80 years are enrolled to the study. Diabetic patients will be included in Group DM and non-diabetics will be included in Group NODM. All patients will receive ultrasound-guided ICBs with the mixture of 15 mL lidocaine 2% and 15 mL bupivacaine 0.5%. Postoperatively, patients will be administered diclomec SR 75 mg IM first and if still needed tramadol 100 mg IV as rescue analgesics (numeric rating scale (NRS) is ≥4). Our primary outcome is sensory block duration, and secondary outcomes are sensory and motor block onset times, motor block duration, time-to-first-pain (numeric rating scale (NRS) ≥4), postoperative NRS scores, and rescue analgesic consumption through the postoperative first 2 days. All outcomes will be assessed by blind investigators.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetic patients | – | Drug: Infraclavicular Brachial Plexus BlocksDiabetic patients will receive ultrasound-guided infraclavicular brachial plexus blocks (ICBs) with the mixture of 15 mL lidocaine 2% and 15 mL bupivacaine 0.5%. |
| Non-diabetic patients | – | Drug: Infraclavicular Brachial Plexus BlocksNondiabetic patients will receive ultrasound-guided infraclavicular brachial plexus blocks (ICBs) with the mixture of 15 mL lidocaine 2% and 15 mL bupivacaine 0.5%. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for arm, elbow, forearm, and hand surgery.
Key inclusion criteria (1 listed)
- Patients scheduled for arm, elbow, forearm, and hand surgery American Society of Anesthesiologists (ASA) physical status I-IV No regional anesthesia contraindication
Key exclusion criteria (1 listed)
- Type 1 DM, Type 2 DM patients with only 'diet-controlled' therapy Difficulty with understanding the block and follow-up instructions Significant neurologic disorders Psychiatric or cognitive disorders History of substance abuse Acute and/or chronic opioid use Local anaesthetic hypersensitivity or allergy
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 |
|---|---|---|
| Infraclavicular Brachial Plexus BlocksAlso: Same interventions, drugs and concentrationsAll patients will receive Infraclavicular Brachial Plexus Blocks with the mixture of lidocaine and bupivacaine. This is an observational study, because all patients will receive the same blocks with the same doses of the local anesthetics. The only difference between groups is including patients with or without Diabetes Mellitus diagnosis. The intervention is the same and these patients cannot be randomized. The aim is investigating the effect of this local anesthetic mixture in Diabetic patients. | Drug | Diabetic patients |
| Infraclavicular Brachial Plexus BlocksAlso: Same interventions, drugs and concentrationsAll patients will receive Infraclavicular Brachial Plexus Blocks with the mixture of lidocaine and bupivacaine. This is an observational study, because all patients will receive the same blocks with the same doses of the local anesthetics. The only difference between groups is including patients with or without Diabetes Mellitus diagnosis. The intervention is the same and these patients cannot be randomized. The aim is investigating the effect of this local anesthetic mixture in Nondiabetic patients. | Drug | Non-diabetic patients |
Primary outcome
Sensory block duration
Time frame: 0-24 hours
Time interval between a successful block (0: full sensation, 1: less sensation, and 2: no sensation) (≥7/8) and the complete restoration of all the senses controlled by the radial, ulnar, median and musculocutaneous nerves (0/8)
6 secondary outcomes
Sensory block onset time
Time frame: 0-30 minutes
Motor block onset time
Time frame: 0-30 minutes
Motor block duration
Time frame: 0-24 hours
Time-to-first pain
Time frame: 0-48 hours
Pain (NRS) scores
Time frame: 0-48 hours
Rescue analgesic consumption
Time frame: 0-48 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 30 Jul 2019.
- Results publication: PubMed 28259276Salviz EA, Onbasi S, Ozonur A, Orhan-Sungur M, Berkoz O, Tugrul KM. Comparison of Ultrasound-Guided Axillary Brachial Plexus Block Properties in Diabetic and Nondiabetic Patients: A Prospective Observational Study. J Hand Surg Am. 2017 Mar;42(3):190-197. doi: 10.1016/j.jhsa.2017.01.009.
- Results publication: PubMed 23348203Cuvillon P, Reubrecht V, Zoric L, Lemoine L, Belin M, Ducombs O, Birenbaum A, Riou B, Langeron O. Comparison of subgluteal sciatic nerve block duration in type 2 diabetic and non-diabetic patients. Br J Anaesth. 2013 May;110(5):823-30. doi: 10.1093/bja/aes496. Epub 2013 Jan 24.
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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.
Emine A Salviz principal investigator
Istanbul University, Medical Faculty of Istanbul
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus and Nerve Block Duration, run by Istanbul University at 2 sites 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 1 inclusion and 1 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 30 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Sensory block duration (time frame: 0-24 hours). 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 NCT03486535, which also lists 2 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 30 Jul 2019.