Evaluation of Second Esmarch Application on Intravenous Regional Anesthesia Effectiveness

NCT03702387 | Unknown

• 1 other identifier: 1705426352
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Keywords

IVRA; Bier Block; Esmarch Bandage

Outcome Measures

Primary Outcomes (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.

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

Study Arms (2)

Control Group

NO INTERVENTION

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

Esmarch Reapplication Group

EXPERIMENTAL

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.

Procedure: standard intravenous regional anesthesia (IVRA) with reapplication of esmach

Interventions

standard intravenous regional anesthesia (IVRA) with reapplication of esmach PROCEDURE

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.

Esmarch Reapplication Group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

University of Arizona

Tucson, Arizona, 85724, United States

RECRUITING

Related Publications (5)

• 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.

  PMID: 14980948 BACKGROUND

• 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.

  PMID: 2720868 BACKGROUND

• 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.

  PMID: 11133629 BACKGROUND

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

  PMID: 6070172 BACKGROUND

• 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.

  PMID: 7968326 BACKGROUND

MeSH Terms

Conditions

Hand Injuries; Disease; Arm Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Tolga Turker, MD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tolga Turker, MD

CONTACT

(520) 626-4024; tturker@ortho.arizona.edu

Daniel Redford, MD

CONTACT

(520) 626-7195; dredford@anesth.arizona.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients will be informed that if they participate in the study, there is a chance they might not receive the modified treatment (and instead receive standard treatment) if they are randomized into the control group. Patients will not be told if they are having the modified IVRA procedure to avoid bias.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: April 20, 2018
• First Posted: October 11, 2018
• Study Start: July 1, 2017
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2020
• Last Updated: October 11, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)