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Hand Injuries and DisordersNCT03702387

Evaluation of Second Esmarch Application on Intravenous Regional Anesthesia Effectiveness

A study testing standard intravenous regional anesthesia (IVRA) with reapplication of esmach in people with Hand Injuries and Disorders and Anesthesia, Local, run by University of Arizona at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Intravenous regional anesthesia is a commonly used technique in the outpatient setting for short hand and upper extremity cases, such as carpal tunnel release or trigger finger release. The technique requires a tourniquet, Esmarch bandage, an intravenous line, and lidocaine. It can be performed and learned easily. Read more about this study

Who is it for?
Ages 18 to 100 yearsHealthy volunteers can take part
What is being tested?
standard intravenous regional anesthesia (IVRA) with reapplication of esmach
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteUnited States
Study dates
1 Jul 2017to Jun 2020
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 100 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Male and female patients aged 18-100.
  • Short upper extremity or hand surgery (cases lasting less than 45 minutes).
  • Must be outpatient surgery.

Who cannot join

  • Patients requesting to withdraw from the study.
  • Patients with a history of drug abuse or illicitly used controlled drugs or substances within the last year.

Trial locations and contacts

1 site in 1 country.

United States1 site, 1 recruiting
  • University of Arizona

    Tucson, Arizona, 85724

    Tolga Turker, MD, 520-626-4024, tturker@ortho.arizona.edu

    Daniel Redford, MD, (520) 626-7195, dredford@anesth.arizona.edu

    Recruiting

Other trials in United States

About this study

Intravenous regional anesthesia is a commonly used technique in the outpatient setting for short hand and upper extremity cases, such as carpal tunnel release or trigger finger release. The technique requires a tourniquet, Esmarch bandage, an intravenous line, and lidocaine. It can be performed and learned easily. The technique is safe and easy to perform, and it provides adequate anesthesia for short cases; however, there are still some cases in which adequate anesthesia is not achieved. One of the possible reasons for failure is that the local anesthetic (lidocaine) does not properly exit the veins to reach the interstitial space (where many nerves are located) to provide the nerve block. In this study, the investigators hypothesize that after application of lidocaine to the intravenous system, application of external pressure through the skin will facilitate tissue penetration and improve the block. The only research procedure being done is a re-application of the Esmarch bandage; all other procedures are Standard of Care.

Read the detailed description

Intravenous regional anesthesia (IVRA), also known as Bier block, is a technically simple and reliable technique for achieving anesthesia for short surgical procedures. It is performed by injecting a local anesthetic (usually lidocaine) intravenously in the setting of a double tourniquet on the upper arm which limits the anesthetic effect to that portion of the body to avoid systemic effects. This technique is suitable for short procedures on the forearm and the hand with minimal complications. Variations of the technique alter the location of the tourniquet, the volume of local anesthetic, or the addition of additional anesthetic agents in an effort to provide the best anesthesia. Despite these variations, the block may still fail. Some studies show a success rate of 94-98% while others show a success rate of 78.1% depending on the definition of success (usually defined by whether or not additional anesthesia was necessary during the surgery). In general, however, IVRA has a high success rate. This study aims to improve the success rate (defined by no additional anesthetic needs during surgery) of IVRA by slightly modifying the IVRA protocol. This modification is described in greater detail below (in the research procedures section), but in essence one of the steps involved in the IVRA procedure is to apply an elastic bandage (Esmarch bandage) to the upper extremity to achieve exsanguination before inflating the double tourniquet. The only modification the investigators are making in this study is to reapply the Esmarch bandage in the exact same fashion after the anesthetic has been injected intravenously. This reapplication of the bandage is not for exsanguination but instead for promoting anesthetic extravasation into the interstitial space. Studies show that the main site of action for IVRA is in the interstitial space where small nerve endings and nerve trunks are located. The modification proposed in this study hopes to improve extravasation of the local anesthetic from the venous system into the interstitial space where it will be better able to function. In this study the investigators hope to compare success rates of the standard technique of IVRA to our method in which the investigators reapply the Esmarch bandage soon after injecting local anesthetic intravenously for short hand and upper extremity cases.

Two groups of human subjects with similar demographics will be used for this research: 40 patients randomly assigned to the control group and 40 patients randomly assigned to the study group. The REDCap randomization module will be used for the randomization process, and this process will take place in clinic on the day the patient is recruited and consented. For patients willing to be part of the study, it will be made absolutely clear to them during the consent process that there is a chance they will be assigned to the control group.

In the pre-operative area on the day of the procedure, patients will be reminded of their voluntary participation in the study (and their ability to withdraw at any time before or after the surgery). At this time the individual who initially recruited/consented the patient (e.g. Dr. Turker or Dr. Morin, henceforth "surgeon") will have the patient fill out the demographic information portion of the Bier Block Research Data Collection Form which includes the following: date of birth, sex, BMI, forearm circumference measured at greatest circumference, and comorbidities. Next, the surgeon will fill out the procedure information section of the data collection form which includes the following: date of the procedure, name of the surgeon, name of the anesthesiologist, name of the procedure, and the side of the procedure. At this point the patient may proceed to surgery.

Intravenous anesthesia will be performed using a tourniquet, Esmarch bandage, an intravenous line, and lidocaine diluted with normal saline. First, intravenous access will be obtained on the surgical side, preferably on the dorsum of the hand (however it is standard procedure to try the wrist or forearm if adequate intravenous access cannot be achieved on the dorsum of the hand). Then, a double tourniquet will be applied to the upper arm. An Esmarch bandage will be applied from the fingertips to the tourniquet with protection of the intravenous line. The distal cuff of the tourniquet will then be inflated to 250-300 mmHg. The proximal cuff will be immediately inflated to the same pressure and the Esmarch bandage will be removed. The patient's radial pulse will be checked and the surgeon will then assess the arm for adequate exsanguination prior to injection of 0.5-1% lidocaine, 25-50 milliliters, depending on patient size and anesthesiologist choice. At this point, if the patient was randomized to the study group, the Esmarch bandage will then be applied again in the exact same fashion as above and then immediately removed (this is the ONLY research portion of the study). If the patient was randomized to the control group, the reapplication of the Esmarch bandage will be skipped. Next, the distal cuff will be deflated and the intravenous line on the surgical side will be removed. Standard surgical preparation will commence while the Bier block sets up. If the patient experiences tourniquet pain, the distal cuff will be inflated and the proximal cuff will be deflated. The time to adequate block will be recorded on the data collection form once the patient is no longer able to feel sharp sensation (typically tested by gently poking skin with a sharp surgical instrument). If at any point during the surgery the patient requires additional anesthesia to control pain, the Bier block will be considered a failure. Once adequate pain control is achieved, the surgery proceeds in the usual fashion. Only cases lasting less than 45 minutes will be included in the study. The remainder of the data collection form will be filled out by the surgeon at the end of the procedure and includes the following information: tourniquet time/pressure, block success/failure, blood pressure at time of tourniquet, whether the Esmarch was applied twice, anesthesia type/dose, anatomical IV placement, complications, and additional anesthesia requirements. These completed data collection forms will then be immediately stored in a locked cabinet in the Human Movement Biomechanics Lab (B103). Every week these forms will be transferred to REDCap, and the hard copies will be destroyed securely.

To reiterate and emphasize, the reapplication of the Esmarch bandage is the only research procedure. All other procedures are standard of care. This step may improve the time to adequate block and quality of anesthesia.

After the data from each of the 80 patients' collection forms have been transferred to REDCap, the research team will review and statistically analyze the data. The duration of participation for patients is the length of surgery (in operating room time).

Being tested
standard intravenous regional anesthesia (IVRA) with reapplication of esmach
Keywords
IVRA, Bier Block, Esmarch Bandage
Medical subject headings
Hand Injuries, Disease, Arm Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • standard intravenous regional anesthesia (IVRA) with reapplication of esmachProcedure or surgery

    his intervention simply adds one additional step to the standard IVRA procedure: reapplication of the Esmarch bandage after lidocaine has been injected intravenously. Everything else about this experimental procedure is standard of care.

Study groups in NCT03702387
Study groupRoleWhat they receive
Control GroupNo interventionPatients in this group will have standard intravenous regional anesthesia (IVRA) performed before the start of their surgery.
Esmarch Reapplication GroupExperimentalPatients in this group will have all the standard intravenous regional anesthesia (IVRA) procedures performed before the start of their surgery with one exception: After standard intravenous regional anesthesia (IVRA) is performed, The elastic Esmarch bandage will be reapplied again on the same arm then will be released. then the surgery will be initiated. the only difference between groups is that the Esmarch reapplied group will be applied the esmach two times. First time, at the standard standard intravenous regional anesthesia (IVRA) before the lidocaine injection and second time, after the injection is completed.
Receives: Procedure: standard intravenous regional anesthesia (IVRA) with reapplication of esmach

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. IVRA Block Success Rate

    This study hopes to compare the intravenous regional anesthesia (IVRA) block success rate between the experimental and control groups. The success rate will be defined as whether or not additional anesthesia is needed before or during surgery.

    Measured: This outcome measure will only be measured for the duration of the surgical procedure.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Oct 2018
  2. Study start1 Jul 2017
  3. Primary completionJun 2019 (estimated)
  4. Study completionJun 2020 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Male and female patients aged 18-100 who need short upper extremity or hand surgery (cases lasting less than 45 minutes) in the outpatient setting will be considered for the study. Exclusion criteria: patients requesting to withdraw from the study and patients with a history of drug abuse or illicitly used controlled drugs or substances within the last year. The study population will be divided into two groups: one group receiving the standard IVRA procedure and one group receiving the modified IVRA procedure (which simply includes the reapplication of the Esmarch bandage after the local anesthetic is administered intravenously). Due to limited information from other intravenous regional anesthesia studies, at least 40 subjects in each group will be needed (at least 80 patients total). Any patient who would like to participate will be included regardless of comorbidities. Any patient who refuses participation will be excluded, and patients may withdraw from the study at any time.
Masking
Single blind
Who is masked
Participant
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03702387
Sponsor's protocol ID
1705426352
Status last verified
Oct 2018
First submitted
20 Apr 2018
Last updated
11 Oct 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Memis D, Turan A, Karamanlioglu B, Pamukcu Z, Kurt I. Adding dexmedetomidine to lidocaine for intravenous regional anesthesia. Anesth Analg. 2004 Mar;98(3):835-40, table of contents. doi: 10.1213/01.ane.0000100680.77978.66.

    PubMed 14980948
  • Brown EM, McGriff JT, Malinowski RW. Intravenous regional anaesthesia (Bier block): review of 20 years' experience. Can J Anaesth. 1989 May;36(3 Pt 1):307-10. doi: 10.1007/BF03010770.

    PubMed 2720868
  • Acalovschi I, Cristea T, Margarit S, Gavrus R. Tramadol added to lidocaine for intravenous regional anesthesia. Anesth Analg. 2001 Jan;92(1):209-14. doi: 10.1097/00000539-200101000-00040.

    PubMed 11133629
  • Dunbar RW, Mazze RI. Intravenous regional anesthesia: experience with 779 cases. Anesth Analg. 1967 Nov-Dec;46(6):806-13. No abstract available.

    PubMed 6070172
  • Lai YY, Chang CL, Yeh FC. The site of action of lidocaine in intravenous regional anesthesia. Ma Zui Xue Za Zhi. 1993 Mar;31(1):31-4.

    PubMed 7968326

Questions about this trial

What is this clinical trial studying?

A study testing standard intravenous regional anesthesia (IVRA) with reapplication of esmach in people with Hand Injuries and Disorders and Anesthesia, Local, run by University of Arizona at 1 site in United States.

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 2 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: status not confirmed, as of the sponsor's last update on 11 Oct 2018. 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 United States. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Tolga Turker, MD ((520) 626-4024, tturker@ortho.arizona.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

IVRA Block Success Rate (time frame: This outcome measure will only be measured for the duration of the surgical procedure.). 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 NCT03702387, which also lists 5 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 11 Oct 2018.

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