Pain, PostoperativeNCT05656625
Comparison of Ultrasound-guided Brachial Plexus Blocks and Selective Distal Blocks in Terms of Anesthesia
An observational study of Pain, Postoperative and Anesthesia, Local, run by Samsun University at 1 site in Turkey (Türkiye).
Trial summary
Ultrasound-guided brachial plexus blocks (infraclavicular, axillary) can be applied as the main anesthetic method in hand and wrist surgeries, as well as single or combination block applications of the median, radial and ulnar nerves at the forearm level. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative, Anesthesia, Local, Patient Satisfaction
- What is being tested?
- descriptive
- How many people
- 2 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Dec 2022to 29 Dec 2022
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients over the age of 18 who go to hand and wrist surgery will be included.
Who may be able to join
- Patients over the age of 18 who go to hand and wrist surgery will be included.
Who cannot join
- Patients who have undergone surgical intervention in more than one region in the same session and who have psychiatric disorders that will affect the perception of pain will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Ultrasound-guided Brachial Plexus Blocks and Selective Distal Blocks in Terms of Anesthesia Success and Discharge Time in Hand and Wrist Surgeries: A Single Center, Historic Cohort Study
Ultrasound-guided brachial plexus blocks (infraclavicular, axillary) can be applied as the main anesthetic method in hand and wrist surgeries, as well as single or combination block applications of the median, radial and ulnar nerves at the forearm level.
Here, we aimed to retrospectively evaluate the perioperative and postoperative data of patients who underwent hand and wrist surgery under distal nerve blocks and brachial plexus blocks in our hospital.
Read the detailed description
The retrospective files of patients who used ultrasound guided regional anesthesia techniques as the main anesthetic method in hand and wrist surgeries in our hospital between 01.01.2021 and 01.09.2022 will be examined. Patients over the age of 18 who go to hand and wrist surgery will be included. Patients who have undergone surgical intervention in more than one region in the same session and who have psychiatric disorders that will affect the perception of pain will be excluded from the study. Demographic characteristics, American Society of Anesthesiology (ASA) scores, comorbidity, block performed (distal peripheral nerve block and/or brachial nerve block) and volume applied, block performance time, first analgesia times, surgery times, surgery types, discharge times, additional The existence of the complaint will be recorded. The data obtained by grouping the patients according to the type of anesthesia applied (brachial plexus block and distal nerve blocks) will be subjected to statistical analysis.
- Conditions
- Pain, Postoperative, Anesthesia, Local, Patient Satisfaction
- Being tested
- descriptive
- Keywords
- distal nerve block,patient satisfaction,hand surgery
- Medical subject headings
- Pain, Postoperative, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
descriptiveOther
The block performed (distal peripheral nerve block and/or brachial nerve block) and the volume applied, block performance time, first analgesia times, surgery times, surgery types, discharge times, presence of additional complaints will be recorded. The data obtained by grouping the patients according to the type of anesthesia applied (brachial plexus block and distal nerve blocks) will be subjected to statistical analysis.
| Study group | Role | What they receive |
|---|---|---|
| group distal nerve block(DNB) | Radial, median and ulnar nerve blocks were used alone or in combinations as a method of anesthesia for patients who had undergone hand and wrist surgery. Receives: Other: descriptive | |
| group brachial plexus block(BPB) | Brachial plexus blocks (infraclavicular, axillary etc.) was applied to patients who were going to undergo hand and wrist surgery. Receives: Other: descriptive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality in Anaesthesia
The patients were called by phone and asked to evaluate the anesthesia technique used in their surgery. Three main judgments including 'quality of anesthesia', 'whether they would prefer the same anesthesia again' and 'whether they would recommend this technique to others' were evaluated with a 5-point Likert scale. 5 point Likert scale consists of 5 answer options which will contain two extreme poles and a neutral option connected with intermediate answer options. In evaluation of parient satisfaction, we used 5 point Likert scale example to measure satisfaction is:
(1) Very dissatisfied, (2)Dissatisfied, (3) Neither satisfied nor dissatisfied, (4) Satisfied , (5)Very satisfied .
In other terms, (1) Strongly disagree; (2) Disagree; (3) Neither agree nor disagree; (4) Agree; (5) Strongly agree.
Measured: up 24 hours
Secondary outcomes (4)
discharge time
The time of discharge will be specified in both groups.
Measured: up to 24 hours
block performance time
Block performance time was defined as the time from ultrasound probe insertion to needle removal at the end of perineural injections.
Measured: intraoperative
additional anesthetic/analgesic requirement
additional analgesic requirement will be evaluated intraoperatively or postoperatively.
Measured: perioperative period
complications
The presence of complications will be evaluated during and after the block.
Measured: up to 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 2022
- Study start20 Dec 2022
- Primary completion29 Dec 2022
- Study completion29 Dec 2022
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 Pain, PostoperativeStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsun University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gamze Ertas, Samsun University
- Investigators
- gamze MD ertaş, specialist, Principal investigator, Samsun University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05656625
- Sponsor's protocol ID
- distal block
- Status last verified
- Dec 2022
- First submitted
- 21 Nov 2022
- Last updated
- 30 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Soberon JR Jr, Crookshank JW 3rd, Nossaman BD, Elliott CE, Sisco-Wise LE, Duncan SF. Distal Peripheral Nerve Blocks in the Forearm as an Alternative to Proximal Brachial Plexus Blockade in Patients Undergoing Hand Surgery: A Prospective and Randomized Pilot Study. J Hand Surg Am. 2016 Oct;41(10):969-977. doi: 10.1016/j.jhsa.2016.07.092. Epub 2016 Aug 11.
PubMed 27524691Ince I, Aksoy M, Celik M. Can We Perform Distal Nerve Block Instead of Brachial Plexus Nerve Block Under Ultrasound Guidance for Hand Surgery? Eurasian J Med. 2016 Oct;48(3):167-171. doi: 10.5152/eurasianjmed.2016.0256.
PubMed 28149139
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ultrasound-guided Brachial Plexus Blocks and Selective Distal Blocks in Terms of Anesthesia Success and Discharge Time in Hand and Wrist Surgeries: A Single Center, Historic Cohort Study
- ClinicalTrials.gov ID
- NCT05656625
- Acronym / sponsor ID
- distal block
- Conditions
- Pain, Postoperative, Anesthesia, Local, Patient Satisfaction
- Keywords
- distal nerve block,patient satisfaction,hand surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Samsun UniversityUniversity, hospital or other
- Study start
- 20 Dec 2022 (actual)
- Primary completion
- 29 Dec 2022 (actual)
- Study completion
- 29 Dec 2022 (actual)
- First posted
- 19 Dec 2022 (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.
Ultrasound-guided brachial plexus blocks (infraclavicular, axillary) can be applied as the main anesthetic method in hand and wrist surgeries, as well as single or combination block applications of the median, radial and ulnar nerves at the forearm level.
Here, we aimed to retrospectively evaluate the perioperative and postoperative data of patients who underwent hand and wrist surgery under distal nerve blocks and brachial plexus blocks in our hospital.
Detailed description
The retrospective files of patients who used ultrasound guided regional anesthesia techniques as the main anesthetic method in hand and wrist surgeries in our hospital between 01.01.2021 and 01.09.2022 will be examined. Patients over the age of 18 who go to hand and wrist surgery will be included. Patients who have undergone surgical intervention in more than one region in the same session and who have psychiatric disorders that will affect the perception of pain will be excluded from the study. Demographic characteristics, American Society of Anesthesiology (ASA) scores, comorbidity, block performed (distal peripheral nerve block and/or brachial nerve block) and volume applied, block performance time, first analgesia times, surgery times, surgery types, discharge times, additional The existence of the complaint will be recorded. The data obtained by grouping the patients according to the type of anesthesia applied (brachial plexus block and distal nerve blocks) will be subjected to statistical analysis.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group distal nerve block(DNB) | – | Other: descriptiveRadial, median and ulnar nerve blocks were used alone or in combinations as a method of anesthesia for patients who had undergone hand and wrist surgery. |
| group brachial plexus block(BPB) | – | Other: descriptiveBrachial plexus blocks (infraclavicular, axillary etc.) was applied to patients who were going to undergo hand and wrist surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over the age of 18 who go to hand and wrist surgery will be included.
Key inclusion criteria (1 listed)
- Patients over the age of 18 who go to hand and wrist surgery will be included.
Key exclusion criteria (1 listed)
- Patients who have undergone surgical intervention in more than one region in the same session and who have psychiatric disorders that will affect the perception of pain will be excluded from 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 |
|---|---|---|
| descriptiveThe block performed (distal peripheral nerve block and/or brachial nerve block) and the volume applied, block performance time, first analgesia times, surgery times, surgery types, discharge times, presence of additional complaints will be recorded. The data obtained by grouping the patients according to the type of anesthesia applied (brachial plexus block and distal nerve blocks) will be subjected to statistical analysis. | Other | group brachial plexus block(BPB), group distal nerve block(DNB) |
Primary outcome
Quality in Anaesthesia
Time frame: up 24 hours
The patients were called by phone and asked to evaluate the anesthesia technique used in their surgery. Three main judgments including 'quality of anesthesia', 'whether they would prefer the same anesthesia again' and 'whether they would recommend this technique to others' were evaluated with a 5-point Likert scale. 5 point Likert scale consists of 5 answer options which will contain two extreme poles and a neutral option connected with intermediate answer options. In evaluation of parient satisfaction, we used 5 point Likert scale example to measure satisfaction is: (1) Very dissatisfied, (2)Dissatisfied, (3) Neither satisfied nor dissatisfied, (4) Satisfied , (5)Very satisfied . In other terms, (1) Strongly disagree; (2) Disagree; (3) Neither agree nor disagree; (4) Agree; (5) Strongly agree.
4 secondary outcomes
discharge time
Time frame: up to 24 hours
block performance time
Time frame: intraoperative
additional anesthetic/analgesic requirement
Time frame: perioperative period
complications
Time frame: up to 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 30 Dec 2022.
- Results publication: PubMed 27524691Soberon JR Jr, Crookshank JW 3rd, Nossaman BD, Elliott CE, Sisco-Wise LE, Duncan SF. Distal Peripheral Nerve Blocks in the Forearm as an Alternative to Proximal Brachial Plexus Blockade in Patients Undergoing Hand Surgery: A Prospective and Randomized Pilot Study. J Hand Surg Am. 2016 Oct;41(10):969-977. doi: 10.1016/j.jhsa.2016.07.092. Epub 2016 Aug 11.
- Results publication: PubMed 28149139Ince I, Aksoy M, Celik M. Can We Perform Distal Nerve Block Instead of Brachial Plexus Nerve Block Under Ultrasound Guidance for Hand Surgery? Eurasian J Med. 2016 Oct;48(3):167-171. doi: 10.5152/eurasianjmed.2016.0256.
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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.
gamze MD ertaş, specialist principal investigator
Samsun University
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 Pain, Postoperative and Anesthesia, Local, run by Samsun 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 30 Dec 2022. 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?
Quality in Anaesthesia (time frame: up 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 NCT05656625, 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 Dec 2022.