Recruiting

Intravenous Regional Anesthesia

Sponsor:

University of Arizona

Code:

NCT03702387

Conditions

Hand Injuries and Disorders

Anesthesia, Local

Upper Extremity Injury

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

standard intravenous regional anesthesia (IVRA) with reapplication of esmach

Study Details

Brief 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. 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.

Conditions

Hand Injuries and Disorders

Anesthesia, Local

Upper Extremity Injury

Study ID

NCT03702387

Start date

Jul 1, 2017

Status verified date

Oct, 2018

Completion date

Jun, 2020

Anticipated

Primary completion date

Jun, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Control Group

Patients in this group will have standard intravenous regional anesthesia (IVRA) performed before the start of their surgery.

experimental: Esmarch Reapplication Group

Patients 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.

Interventions

standard intravenous regional anesthesia (IVRA) with reapplication of esmach

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.

Primary outcome measure

  • IVRA Block Success Rate [ Time Frame: This outcome measure will only be measured for the duration of the surgical procedure. ]

Central Contacts and Locations

Locations

University of Arizona

Recruiting

Tucson, Arizona, United States, 85724

Contacts

More Information

Sponsor

University of Arizona

Last update posted

Oct 11, 2018

Last verified

Oct, 2018

Keywords

  • IVRA
  • Bier Block
  • Esmarch Bandage

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Arizona on 2018-10-11.