Forearm SurgeryNCT06027918
The Effect of Altitude Difference on the Duration of Nerve Block; A Three-Center Study.
A study testing Infraclavicular brachial plexus block in people with Forearm Surgery, run by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Infraclavicular brachial plexus block in hand and forearm surgery has the advantages of high success rate and low risk of complications and is useful in providing long-lasting and effective postoperative analgesia in these patients. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Forearm Surgery
- What is being tested?
- Infraclavicular brachial plexus block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Oct 2023to 16 Apr 2024
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Between 18-55 years old
- Body mass index between 20 and 25
- Patients with American Society of Anesthesiologists classification (ASA) physical status I or II
Who cannot join
- Patients aged younger than 18 and older than 55 years
- American Society of Anesthesiologists classification (ASA) ≥ III
- Body mass index (BMI) >35
- Known history of allergy to local anesthetics preoperative chronic pain and therefore long-term analgesic use
- In case of coagulopathy
- Have a condition that constitutes a contraindication for the application of the block (local infection, sepsis, local anesthetic medicine allergy; severe neurological, muscular or psychiatric disease, coagulation disorders)
- With marked cognitive impairment
- Patients who did not want to participate in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Diyarbakır, 21070
About this study
Official title: The Effect of Altitude Difference on the Duration of Infraclavicular Peripheral Block Applied to Patients With Hand and Forearm Fractures; a Three-center Study in Adults at 100, 675, 1726 Meters
Infraclavicular brachial plexus block in hand and forearm surgery has the advantages of high success rate and low risk of complications and is useful in providing long-lasting and effective postoperative analgesia in these patients. In response to hypoxemia at high altitude, increased blood viscosity, decreased carbon monoxide diffusion capacity, increased cerebral arterial blood flow, decreased blood volume and decreased cardiac output occur. At high altitude, the serum level of local anesthetics may increase due to an increase in their ionized fraction and a decrease in their clearance. In this respect, the pharmacodynamic and pharmacokinetic properties of peripheral nerve blocks may be altered when performed at high altitude. The primary objective of this prospective study was to test the hypothesis that postoperative pain scores are higher in patients undergoing infraclavicular nerve block at high altitude than in patients at low altitude.
This multicenter prospective randomized study will be initiated after approval of the Ethics Committee of Health ScienceUniversity Diyarbakir Gazi Yasargil Training and Research Hospital. Patients will be recruited simultaneously in 3 hospitals, Hatay Training and Research Hospital, Hatay, Turkey (100 m above sea level);Health Science Health Science University Diyarbakir Gazi Yasargil Training and Research Hospital, Diyarbakir, Turkey (675 m above sea level) and Health Science University Van Regional and Training Research Hospital, Van, Turkey (1726 m above sea level).
Infraclavicular brachial plexus blocks (coracoid approach) will be performed by administering a local anesthetic mixture of 1.5 mg/kg lidocaine 2% + 1 mg/kg bupivacaine 0.5% at the 6 o'clock position of the axillary artery under US guidance.
Read the detailed description
Group V (1726 meter altitude): In the application of infraclavicular brachial plexus blocks (coracoid approach); 1.5mg/kg dose of bupivacaine and 1mg/kg lidocaine mixture will be applied around the axillary artery in the 6 o'clock position under US guidance.
- The block will be applied only once, approximately 15-20 minutes before surgery.
- All patients will undergo electrocardiographic monitoring, oxygen saturation monitoring with pulse oximetry and blood pressure measurement with automatic pneumatic manometer before the application.
- Intravenous 1mg midazolam and 50 mcg fentanyl will be administered to all patients for premedication before the procedure.
- The amount of medication to be given to all patients will be prepared as 1.5mg/kg bupivacaine and 1mg/kg lidocaine.
- The prepared drug will be administered around the axillary artery at the appropriate anatomical location determined under ultrasound guidance.
- Ultrasound device will be used as a supportive device during the application.
- The application will be performed by an anesthesiologist with at least 5 years of experience.
- mode of delivery will be provided face to face and individually
- The administration will be only once, 20-30 minutes before the surgical procedure, with a dose adjustment of 1.5mg/kg bupivacaine and 1mg/kg lidocaine per kilogram of weight.
- The application will be made in the preoperative preparation room in the operating room of the hospital where the surgery will be performed.
- The local anesthetic dose to be used in the application will be calculated according to the weight of the patient. local anesthetics will be prepared by another anesthesiologist in the preoperative preparation room just before the application.
- In the postoperative period, if the pain intensity (VAS) is <4, 100 mg paracetamol will be administered intravenously, if VAS = 4, 100 mg tramadol will be administered intravenously
Group D (675 meter altitude): In the application of infraclavicular brachial plexus blocks (coracoid approach); 1.5 mg/kg dose of bupivacaine and 1mg/kg lidocaine mixture will be applied around the axillary artery in the 6 o'clock position under US guidance.
- The block will be applied only once, approximately 15-20 minutes before surgery.
- All patients will undergo electrocardiographic monitoring, oxygen saturation monitoring with pulse oximetry and blood pressure measurement with automatic pneumatic manometer before the application.
- Intravenous 1mg midazolam and 50 mcg fentanyl will be administered to all patients for premedication before the procedure.
- The amount of medication to be given to all patients will be prepared as 1.5 mg/kg bupivacaine and 1mg/kg lidocaine.
- The prepared drug will be administered around the axillary artery at the appropriate anatomical location determined under ultrasound guidance.
- Ultrasound device will be used as a supportive device during the application.
- The application will be performed by an anesthesiologist with at least 5 years of experience.
- mode of delivery will be provided face to face and individually
- The administration will be only once, 20-30 minutes before the surgical procedure, with a dose adjustment of 1.5 mg/kg bupivacaine and 1mg/kg lidocaine per kilogram of weight.
- The application will be made in the preoperative preparation room in the operating room of the hospital where the surgery will be performed.
- The local anesthetic dose to be used in the application will be calculated according to the weight of the patient. local anesthetics will be prepared by another anesthesiologist in the preoperative preparation room just before the application.
- In the postoperative period, if the pain intensity (VAS) is <4, 100 mg paracetamol will be administered intravenously, if VAS = 4, 100 mg tramadol will be administered intravenously
Comparator / control treatment Group H (100 meter altitude): In the application of infraclavicular brachial plexus blocks (coracoid approach); 1.5 mg/kg dose of bupivacaine and 1mg/kg lidocaine mixture will be applied around the axillary artery in the 6 o'clock position under US guidance.
- The block will be applied only once, approximately 15-20 minutes before surgery.
- All patients will undergo electrocardiographic monitoring, oxygen saturation monitoring with pulse oximetry and blood pressure measurement with automatic pneumatic manometer before the application.
- Intravenous 1mg midazolam and 50 mcg fentanyl will be administered to all patients for premedication before the procedure.
- The amount of medication to be given to all patients will be prepared as 1.5 mg/kg bupivacaine and 1 mg/kg lidocaine.
- The prepared drug will be administered around the axillary artery at the appropriate anatomical location determined under ultrasound guidance.
- Ultrasound device will be used as a supportive device during the application.
- The application will be performed by an anesthesiologist with at least 5 years of experience.
- mode of delivery will be provided face to face and individually
- The administration will be only once, 20-30 minutes before the surgical procedure, with a dose adjustment of 1.5 mg/kg bupivacaine and 1mg/kg lidocaine per kilogram of weight.
- The application will be made in the preoperative preparation room in the operating room of the hospital where the surgery will be performed.
- The local anesthetic dose to be used in the application will be calculated according to the weight of the patient. local anesthetics will be prepared by another anesthesiologist in the preoperative preparation room just before the application.
- In the postoperative period, if the pain intensity (VAS) is <4, 100 mg paracetamol will be administered intravenously, if VAS = 4, 100 mg tramadol will be administered intravenously
- Conditions
- Forearm Surgery
- Being tested
- Infraclavicular brachial plexus block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infraclavicular brachial plexus blockProcedure or surgery
In the application of infraclavicular brachial plexus blocks (coracoid approach); 1.5mg/kg dose of bupivacaine and 1mg/kg lidocaine mixture will be applied around the axillary artery in the 6 o'clock position under US guidance.
| Study group | Role | What they receive |
|---|---|---|
| Group V (1726 meter altitude) | Active comparator | In the application of infraclavicular brachial plexus blocks (coracoid approach); 1.5mg/kg dose of bupivacaine and 1mg/kg lidocaine mixture will be applied around the axillary artery in the 6 o'clock position under US guidance.
The block will be applied only once, approximately 15-20 minutes before surgery. Receives: Procedure: Infraclavicular brachial plexus block |
| Group D (675 meter altitude) | Active comparator | In the application of infraclavicular brachial plexus blocks (coracoid approach); 1.5mg/kg dose of bupivacaine and 1mg/kg lidocaine mixture will be applied around the axillary artery in the 6 o'clock position under US guidance.
The block will be applied only once, approximately 15-20 minutes before surgery. Receives: Procedure: Infraclavicular brachial plexus block |
| Group H( 100 meter altitude) | Active comparator | In the application of infraclavicular brachial plexus blocks (coracoid approach); 1.5mg/kg dose of bupivacaine and 1mg/kg lidocaine mixture will be applied around the axillary artery in the 6 o'clock position under US guidance.
The block will be applied only once, approximately 15-20 minutes before surgery. Receives: Procedure: Infraclavicular brachial plexus block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS)
- The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."
- Pain intensity at the site of the operation.
Measured: will be evaluated at 0, 4th, 8th, 12th, 14th, 16th, 18th, 24th hours postoperatively
Secondary outcomes (5)
total amount of intravenous analgesics consumed
to be evaluated at the end of 24 hours postoperatively
Measured: will be evaluated at 0, 4th, 8th, 12th, 14th, 16th, 18th, 24th hours postoperatively
Sensory block start time
The onset time of sensory block was defined as the time to reach an absence of hot-cold sensation in all 4 nerve distributions after completion of injection of the local anesthetic mixture.
Sensory block was assessed using the cold test on the dermatomes of the median, ulnar, radial and musculocutaneous nerves. Sensory block was graded on a 3-point scale (0: normal sensation, 1: analgesia [patient can feel touch but not cold], 2: anesthesia [patient cannot even feel touch]).
Measured: The sensory block will be evaluated approximately 10 minutes after the application. It will be observed up to a maximum of 30 minutes.
sensory block end time
Sensory block end time: defined as the time when the hot-cold sensation disappears in all 4 nerve distributions after the injection of the local anesthetic mixture is completed.
Measured: It will be evaluated every hour after the implementation, up to a maximum of 120 hours.
Time to onset of motor block
Time to onset of motor block, the time from the completion of injection of the local anesthetic mixture until complete motor block develops (in case of bromage : 4).
Motor block was assessed with the Modified Bromage scale (scale 0: full flexion of the fingers, wrist and elbow; scale 1: full flexion of the fingers and wrist, but no flexion of the elbow); scale 2: full flexion of the fingers, but no flexion of the wrist and elbow; scale 3: complete motor block; no flexion of the fingers, wrist and elbow).
Measured: Motor block onset time will be assessed every 10 minutes after the intervention until 60 minutes.
Motor block end time
Motor block was assessed with the Modified Bromage scale (scale 0: full flexion of the fingers, wrist and elbow; scale 1: full flexion of the fingers and wrist, but no flexion of the elbow); scale 2: full flexion of the fingers, but no flexion of the wrist and elbow; scale 3: complete motor block; no flexion of the fingers, wrist and elbow).
If the bromage is 0, the motor block will be considered as eliminated.
Measured: It will be evaluated every hour after the implementation, up to a maximum of 120 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2023
- Study start3 Oct 2023
- Primary completion15 Apr 2024
- Study completion16 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Forearm SurgeryStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Acil,MD, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
- Investigators
- Cem K. Kaçar, Assoc.Prof, Study director, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06027918
- Sponsor's protocol ID
- 12.09.2022/266
- Status last verified
- May 2024
- First submitted
- 29 Aug 2023
- Last updated
- 23 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Harmon D, Frizelle HP. Supraclavicular block for day-case anaesthesia at altitude. Anaesthesia. 2001 Feb;56(2):197. doi: 10.1046/j.1365-2044.2001.01870-30.x. No abstract available.
PubMed 11167511
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Altitude Difference on the Duration of Infraclavicular Peripheral Block Applied to Patients With Hand and Forearm Fractures; a Three-center Study in Adults at 100, 675, 1726 Meters
- ClinicalTrials.gov ID
- NCT06027918
- Acronym / sponsor ID
- 12.09.2022/266
- Conditions
- Forearm Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Saglik Bilimleri Universitesi Gazi Yasargil Training and Research HospitalUniversity, hospital or other
- Study start
- 3 Oct 2023 (actual)
- Primary completion
- 15 Apr 2024 (actual)
- Study completion
- 16 Apr 2024 (actual)
- First posted
- 7 Sep 2023 (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.
Infraclavicular brachial plexus block in hand and forearm surgery has the advantages of high success rate and low risk of complications and is useful in providing long-lasting and effective postoperative analgesia in these patients. In response to hypoxemia at high altitude, increased blood viscosity, decreased carbon monoxide diffusion capacity, increased cerebral arterial blood flow, decreased blood volume and decreased cardiac output occur. At high altitude, the serum level of local anesthetics may increase due to an increase in their ionized fraction and a decrease in their clearance. In this respect, the pharmacodynamic and pharmacokinetic properties of peripheral nerve blocks may be altered when performed at high altitude. The primary objective of this prospective study was to test the hypothesis that postoperative pain scores are higher in patients undergoing infraclavicular nerve block at high altitude than in patients at low altitude.
This multicenter prospective randomized study will be initiated after approval of the Ethics Committee of Health ScienceUniversity Diyarbakir Gazi Yasargil Training and Research Hospital. Patients will be recruited simultaneously in 3 hospitals, Hatay Training and Research Hospital, Hatay, Turkey (100 m above sea level);Health Science Health Science University Diyarbakir Gazi Yasargil Training and Research Hospital, Diyarbakir, Turkey (675 m above sea level) and Health Science University Van Regional and Training Research Hospital, Van, Turkey (1726 m above sea level).
Infraclavicular brachial plexus blocks (coracoid approach) will be performed by administering a local anesthetic mixture of 1.5 mg/kg lidocaine 2% + 1 mg/kg bupivacaine 0.5% at the 6 o'clock position of the axillary artery under US guidance.
Detailed description
Group V (1726 meter altitude): In the application of infraclavicular brachial plexus blocks (coracoid approach); 1.5mg/kg dose of bupivacaine and 1mg/kg lidocaine mixture will be applied around the axillary artery in the 6 o'clock position under US guidance.
- The block will be applied only once, approximately 15-20 minutes before surgery.
- All patients will undergo electrocardiographic monitoring, oxygen saturation monitoring with pulse oximetry and blood pressure measurement with automatic pneumatic manometer before the application.
- Intravenous 1mg midazolam and 50 mcg fentanyl will be administered to all patients for premedication before the procedure.
- The amount of medication to be given to all patients will be prepared as 1.5mg/kg bupivacaine and 1mg/kg lidocaine.
- The prepared drug will be administered around the axillary artery at the appropriate anatomical location determined under ultrasound guidance.
- Ultrasound device will be used as a supportive device during the application.
- The application will be performed by an anesthesiologist with at least 5 years of experience.
- mode of delivery will be provided face to face and individually
- The administration will be only once, 20-30 minutes before the surgical procedure, with a dose adjustment of 1.5mg/kg bupivacaine and 1mg/kg lidocaine per kilogram of weight.
- The application will be made in the preoperative preparation room in the operating room of the hospital where the surgery will be performed.
- The local anesthetic dose to be used in the application will be calculated according to the weight of the patient. local anesthetics will be prepared by another anesthesiologist in the preoperative preparation room just before the application.
- In the postoperative period, if the pain intensity (VAS) is <4, 100 mg paracetamol will be administered intravenously, if VAS = 4, 100 mg tramadol will be administered intravenously
Group D (675 meter altitude): In the application of infraclavicular brachial plexus blocks (coracoid approach); 1.5 mg/kg dose of bupivacaine and 1mg/kg lidocaine mixture will be applied around the axillary artery in the 6 o'clock position under US guidance.
- The block will be applied only once, approximately 15-20 minutes before surgery.
- All patients will undergo electrocardiographic monitoring, oxygen saturation monitoring with pulse oximetry and blood pressure measurement with automatic pneumatic manometer before the application.
- Intravenous 1mg midazolam and 50 mcg fentanyl will be administered to all patients for premedication before the procedure.
- The amount of medication to be given to all patients will be prepared as 1.5 mg/kg bupivacaine and 1mg/kg lidocaine.
- The prepared drug will be administered around the axillary artery at the appropriate anatomical location determined under ultrasound guidance.
- Ultrasound device will be used as a supportive device during the application.
- The application will be performed by an anesthesiologist with at least 5 years of experience.
- mode of delivery will be provided face to face and individually
- The administration will be only once, 20-30 minutes before the surgical procedure, with a dose adjustment of 1.5 mg/kg bupivacaine and 1mg/kg lidocaine per kilogram of weight.
- The application will be made in the preoperative preparation room in the operating room of the hospital where the surgery will be performed.
- The local anesthetic dose to be used in the application will be calculated according to the weight of the patient. local anesthetics will be prepared by another anesthesiologist in the preoperative preparation room just before the application.
- In the postoperative period, if the pain intensity (VAS) is <4, 100 mg paracetamol will be administered intravenously, if VAS = 4, 100 mg tramadol will be administered intravenously
Comparator / control treatment Group H (100 meter altitude): In the application of infraclavicular brachial plexus blocks (coracoid approach); 1.5 mg/kg dose of bupivacaine and 1mg/kg lidocaine mixture will be applied around the axillary artery in the 6 o'clock position under US guidance.
- The block will be applied only once, approximately 15-20 minutes before surgery.
- All patients will undergo electrocardiographic monitoring, oxygen saturation monitoring with pulse oximetry and blood pressure measurement with automatic pneumatic manometer before the application.
- Intravenous 1mg midazolam and 50 mcg fentanyl will be administered to all patients for premedication before the procedure.
- The amount of medication to be given to all patients will be prepared as 1.5 mg/kg bupivacaine and 1 mg/kg lidocaine.
- The prepared drug will be administered around the axillary artery at the appropriate anatomical location determined under ultrasound guidance.
- Ultrasound device will be used as a supportive device during the application.
- The application will be performed by an anesthesiologist with at least 5 years of experience.
- mode of delivery will be provided face to face and individually
- The administration will be only once, 20-30 minutes before the surgical procedure, with a dose adjustment of 1.5 mg/kg bupivacaine and 1mg/kg lidocaine per kilogram of weight.
- The application will be made in the preoperative preparation room in the operating room of the hospital where the surgery will be performed.
- The local anesthetic dose to be used in the application will be calculated according to the weight of the patient. local anesthetics will be prepared by another anesthesiologist in the preoperative preparation room just before the application.
- In the postoperative period, if the pain intensity (VAS) is <4, 100 mg paracetamol will be administered intravenously, if VAS = 4, 100 mg tramadol will be administered intravenously
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group V (1726 meter altitude) | Active comparator | Procedure: Infraclavicular brachial plexus blockIn the application of infraclavicular brachial plexus blocks (coracoid approach); 1.5mg/kg dose of bupivacaine and 1mg/kg lidocaine mixture will be applied around the axillary artery in the 6 o'clock position under US guidance. The block will be applied only once, approximately 15-20 minutes before surgery. |
| Group D (675 meter altitude) | Active comparator | Procedure: Infraclavicular brachial plexus blockIn the application of infraclavicular brachial plexus blocks (coracoid approach); 1.5mg/kg dose of bupivacaine and 1mg/kg lidocaine mixture will be applied around the axillary artery in the 6 o'clock position under US guidance. The block will be applied only once, approximately 15-20 minutes before surgery. |
| Group H( 100 meter altitude) | Active comparator | Procedure: Infraclavicular brachial plexus blockIn the application of infraclavicular brachial plexus blocks (coracoid approach); 1.5mg/kg dose of bupivacaine and 1mg/kg lidocaine mixture will be applied around the axillary artery in the 6 o'clock position under US guidance. The block will be applied only once, approximately 15-20 minutes before surgery. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Between 18-55 years old
- Body mass index between 20 and 25
- Patients with American Society of Anesthesiologists classification (ASA) physical status I or II
Key exclusion criteria (8 listed)
- Patients aged younger than 18 and older than 55 years
- American Society of Anesthesiologists classification (ASA) ≥ III
- Body mass index (BMI) >35
- Known history of allergy to local anesthetics preoperative chronic pain and therefore long-term analgesic use
- In case of coagulopathy
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 blockIn the application of infraclavicular brachial plexus blocks (coracoid approach); 1.5mg/kg dose of bupivacaine and 1mg/kg lidocaine mixture will be applied around the axillary artery in the 6 o'clock position under US guidance. | Procedure or surgery | Group D (675 meter altitude), Group H( 100 meter altitude), Group V (1726 meter altitude) |
Primary outcome
Visual Analogue Scale (VAS)
Time frame: will be evaluated at 0, 4th, 8th, 12th, 14th, 16th, 18th, 24th hours postoperatively
* The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain." * Pain intensity at the site of the operation.
5 secondary outcomes
total amount of intravenous analgesics consumed
Time frame: will be evaluated at 0, 4th, 8th, 12th, 14th, 16th, 18th, 24th hours postoperatively
Sensory block start time
Time frame: The sensory block will be evaluated approximately 10 minutes after the application. It will be observed up to a maximum of 30 minutes.
sensory block end time
Time frame: It will be evaluated every hour after the implementation, up to a maximum of 120 hours.
Time to onset of motor block
Time frame: Motor block onset time will be assessed every 10 minutes after the intervention until 60 minutes.
Motor block end time
Time frame: It will be evaluated every hour after the implementation, up to a maximum of 120 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 23 May 2024.
- Background: PubMed 11167511Harmon D, Frizelle HP. Supraclavicular block for day-case anaesthesia at altitude. Anaesthesia. 2001 Feb;56(2):197. doi: 10.1046/j.1365-2044.2001.01870-30.x. No abstract available.
- 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.
Cem K. Kaçar, Assoc.Prof study director
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infraclavicular brachial plexus block in people with Forearm Surgery, run by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research 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 8 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 23 May 2024. 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?
Visual Analogue Scale (VAS) (time frame: will be evaluated at 0, 4th, 8th, 12th, 14th, 16th, 18th, 24th hours postoperatively). 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 NCT06027918, which also lists 1 linked publication.
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 23 May 2024.