Diabetes MellitusNCT02685475
Axillary Block Properties in Diabetic Patients
An observational study of Diabetes Mellitus and Nerve Block Duration, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
Background and objectives: The investigators performed this study to explore whether the presence of diabetes mellitus (DM) would affect the outcomes of axillary brachial plexus blocks (ABPBs) in patients undergoing elective forearm and/or hand surgery. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Nerve Block Duration, Pain, Postoperative
- What is being tested?
- Axillary Brachial Plexus Blocks
- How many people
- 71 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Feb 2015to Jan 2016
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for elective forearm and/or hand surgery
Who may be able to join
- Patients scheduled for elective forearm and/or hand surgery American Society of Anesthesiologists (ASA) physical status I-III 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
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University, Department of Anesthesiology
Istanbul, Fatih, 34093
About this study
Official title: Comparison of Ultrasound-Guided Axillary Brachial Plexus Block Properties in Diabetic and Non-diabetic Patients: A Prospective Observational Study
Background and objectives: The investigators performed this study to explore whether the presence of diabetes mellitus (DM) would affect the outcomes of axillary brachial plexus blocks (ABPBs) in patients undergoing elective forearm and/or hand surgery. The primary hypothesis was that the sensory block duration would be delayed in diabetic patients.
Methods: After obtaining ethics committee approval and written informed consent, 71 patients were enrolled to the study. Diabetic patients were included in Group DM and non-diabetics were included in Group NODM. All received ultrasound-guided ABPBs with the mixture of 10 mL lidocaine 2% and 20 mL bupivacaine 0.5%. Our primary outcome was sensory block duration, and secondary outcomes were 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 were assessed by a blinded investigators.
Read the detailed description
Background and objectives: The impact of diabetes mellitus (DM) on the practice of peripheral nerve block anesthesia was mostly investigated in animal researches, and effects on human models are required to be clarified. The investigators performed this study to explore whether the presence of DM would affect the outcomes of axillary brachial plexus blocks (ABPBs) in patients undergoing elective forearm and/or hand surgery. The primary hypothesis was that the sensory block duration would be delayed in diabetic patients.
Methods: After obtaining ethics committee approval and written informed consent, 71 patients with American Society of Anesthesiologists (ASA) physical status I-III and aged between 40 and 75 years were enrolled to the study. Diabetic patients were included in Group DM and non-diabetics were included in Group NODM. All received ultrasound-guided ABPBs with the mixture of 10 mL lidocaine 2% and 20 mL bupivacaine 0.5%. Postoperatively, patients were administered paracetamol as rescue analgesics, if numeric rating scale (NRS) was ≥4. Our primary outcome was sensory block duration, and secondary outcomes were 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 were assessed by a blinded investigators.
- Conditions
- Diabetes Mellitus, Nerve Block Duration, Pain, Postoperative
- Being tested
- Axillary Brachial Plexus Blocks
- Keywords
- Diabetes mellitus, Axillary 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.
Axillary Brachial Plexus BlocksDrug
Also called ABPBs
All patients received ultrasound-guided axillary brachial plexus block (ABPBs) with the mixture of 10 mL lidocaine 2% and 20 mL bupivacaine 0.5%.
| Study group | Role | What they receive |
|---|---|---|
| Diabetic patients | Patients received ultrasound-guided axillary brachial plexus blocks (ABPBs) with the mixture of 10 mL lidocaine 2% and 20 mL bupivacaine 0.5%. Receives: Drug: Axillary Brachial Plexus Blocks | |
| Non-diabetic patients | Patients received ultrasound-guided axillary brachial plexus blocks (ABPBs) with the mixture of 10 mL lidocaine 2% and 20 mL bupivacaine 0.5%. Receives: Drug: Axillary 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 and the complete restoration of all the senses controlled by the radial, ulnar, median and musculocutaneous nerves.
Measured: 0-24 hours
Secondary outcomes (6)
Sensory block onset time
Physical examination with pin-prick test (≥7/8)
Measured: 0-30 minutes
Motor block onset time
Physical examination with modified Bromage scale (≥9/12)
Measured: 0-30 minutes
Motor block duration
Time interval between a successful block and the complete restoration of all motor responses controlled by the radial, ulnar, median and musculocutaneous nerves.
Measured: 0-24 hours
Time-to-first pain
Postoperative first pain (NRS ≥4)
Measured: 0-48 hours
Pain (NRS) scores
Numeric rating scale (NRS) pain scores (0: no pain, 10: worst pain imaginable)
Measured: 0-48 hours
Rescue analgesic consumption
Used postoperatively if NRS ≥4
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 posted18 Feb 2016 (estimated)
- Study startFeb 2015
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 71 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, MD, Principal investigator, Design and conduct the study, review and analyze the data, and write the manuscript
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02685475
- Sponsor's protocol ID
- 2014/1869
- Status last verified
- Mar 2016
- First submitted
- 13 Feb 2016
- Last updated
- 16 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Gebhard RE, Nielsen KC, Pietrobon R, Missair A, Williams BA. Diabetes mellitus, independent of body mass index, is associated with a "higher success" rate for supraclavicular brachial plexus blocks. Reg Anesth Pain Med. 2009 Sep-Oct;34(5):404-7. doi: 10.1097/AAP.0b013e3181ada58d.
PubMed 19920415Sertoz N, Deniz MN, Ayanoglu HO. Relationship between glycosylated hemoglobin level and sciatic nerve block performance in diabetic patients. Foot Ankle Int. 2013 Jan;34(1):85-90. doi: 10.1177/1071100712460366.
PubMed 23386766Cuvillon 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 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ultrasound-Guided Axillary Brachial Plexus Block Properties in Diabetic and Non-diabetic Patients: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT02685475
- Acronym / sponsor ID
- 2014/1869
- Conditions
- Diabetes Mellitus, Nerve Block Duration, Pain, Postoperative
- Keywords
- Diabetes mellitus, Axillary brachial plexus block, Block duration, Time-to-first pain, Postoperative analgesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 18 Feb 2016 (estimated)
- 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 performed this study to explore whether the presence of diabetes mellitus (DM) would affect the outcomes of axillary brachial plexus blocks (ABPBs) in patients undergoing elective forearm and/or hand surgery. The primary hypothesis was that the sensory block duration would be delayed in diabetic patients.
Methods: After obtaining ethics committee approval and written informed consent, 71 patients were enrolled to the study. Diabetic patients were included in Group DM and non-diabetics were included in Group NODM. All received ultrasound-guided ABPBs with the mixture of 10 mL lidocaine 2% and 20 mL bupivacaine 0.5%. Our primary outcome was sensory block duration, and secondary outcomes were 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 were assessed by a blinded investigators.
Detailed description
Background and objectives: The impact of diabetes mellitus (DM) on the practice of peripheral nerve block anesthesia was mostly investigated in animal researches, and effects on human models are required to be clarified. The investigators performed this study to explore whether the presence of DM would affect the outcomes of axillary brachial plexus blocks (ABPBs) in patients undergoing elective forearm and/or hand surgery. The primary hypothesis was that the sensory block duration would be delayed in diabetic patients.
Methods: After obtaining ethics committee approval and written informed consent, 71 patients with American Society of Anesthesiologists (ASA) physical status I-III and aged between 40 and 75 years were enrolled to the study. Diabetic patients were included in Group DM and non-diabetics were included in Group NODM. All received ultrasound-guided ABPBs with the mixture of 10 mL lidocaine 2% and 20 mL bupivacaine 0.5%. Postoperatively, patients were administered paracetamol as rescue analgesics, if numeric rating scale (NRS) was ≥4. Our primary outcome was sensory block duration, and secondary outcomes were 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 were assessed by a blinded investigators.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetic patients | – | Drug: Axillary Brachial Plexus BlocksPatients received ultrasound-guided axillary brachial plexus blocks (ABPBs) with the mixture of 10 mL lidocaine 2% and 20 mL bupivacaine 0.5%. |
| Non-diabetic patients | – | Drug: Axillary Brachial Plexus BlocksPatients received ultrasound-guided axillary brachial plexus blocks (ABPBs) with the mixture of 10 mL lidocaine 2% and 20 mL bupivacaine 0.5%. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for elective forearm and/or hand surgery
Key inclusion criteria (1 listed)
- Patients scheduled for elective forearm and/or hand surgery American Society of Anesthesiologists (ASA) physical status I-III 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 |
|---|---|---|
| Axillary Brachial Plexus BlocksAlso: ABPBsAll patients received ultrasound-guided axillary brachial plexus block (ABPBs) with the mixture of 10 mL lidocaine 2% and 20 mL bupivacaine 0.5%. | Drug | Diabetic patients, Non-diabetic patients |
Primary outcome
Sensory block duration
Time frame: 0-24 hours
Time interval between a successful block and the complete restoration of all the senses controlled by the radial, ulnar, median and musculocutaneous nerves.
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 16 Mar 2016.
- Results publication: PubMed 19920415Gebhard RE, Nielsen KC, Pietrobon R, Missair A, Williams BA. Diabetes mellitus, independent of body mass index, is associated with a "higher success" rate for supraclavicular brachial plexus blocks. Reg Anesth Pain Med. 2009 Sep-Oct;34(5):404-7. doi: 10.1097/AAP.0b013e3181ada58d.
- Results publication: PubMed 23386766Sertoz N, Deniz MN, Ayanoglu HO. Relationship between glycosylated hemoglobin level and sciatic nerve block performance in diabetic patients. Foot Ankle Int. 2013 Jan;34(1):85-90. doi: 10.1177/1071100712460366.
- 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.
- Individual participant dataSharing planned: No
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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, MD principal investigator
Design and conduct the study, review and analyze the data, and write the manuscript
1 site 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 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 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 16 Mar 2016. 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?
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 NCT02685475, which also lists 3 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 16 Mar 2016.