The Effect of Forearm Nerve Blocks on Pain-free Tourniquet Time Compared to Local Anesthetic for Awake Hand Surgery

NCT04787835 | Unknown

• 1 other identifier: B2021:003
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

Wide-awake surgery with local anesthesia is a widely described approach to performing numerous minor hand procedures, such as tendon repairs and percutaneous fracture pinning, but is less frequently used for longer procedures such as open reduction internal fixation (ORIF). This is in part due to the need for a tourniquet for improved visualization, however pain-free tourniquet time with local anesthesia is roughly 20 minutes, shorter than the average time for ORIFs (Gillis), for example. While general anesthesia may still be avoided with more proximal blocks such as a brachial plexus or bier blocks, these still require presence of an anesthesiologist during the procedure, increasing human resource utilization and costs. Development of an anesthetic technique for hand surgery which could be performed by surgeons in a clinic setting, that still provides sufficiently long pain-free tourniquet times could decreases costs and wait times. The investigators hypothesize that the pain patients experience after 20 minutes of tourniquet application with local anesthetic infiltration is not due to direct pressure on the proximal arm, but rather distal digital ischemia pain. Previously, it has been shown that ultrasound-guided regional block of the median, radial, and ulnar nerves in the forearm is effective analgesia for awake hand surgery (Winter). Currently, there are no randomized studies investigating if forearm nerve blocks can prolong pain-free tourniquet time compared to local anesthesia infiltration, by blocking this ischemic pain in the distal arm. The investigators' objective is therefore to determine if forearm nerve blocks prolong pain-free tourniquet time compared to local anesthetic infiltration.

Conditions

Fracture Fixation, Internal; Metacarpal Fracture; Finger Fracture; Anesthesia, Local; Tendon Injury - Hand

Keywords

Anesthesia, local; Minor surgical procedure; Hand injuries

Outcome Measures

Primary Outcomes (1)

• Pain-free tourniquet time (minutes)

  When upper extremity surgery is performed with local anesthesia and a tourniquet, the tourniquet must be removed after roughly 20 minutes as patients begin to feel tingling and pain in their hand. Pain-free tourniquet time refers to the amount of time the tourniquet is applied before the patient begins to feel an uncomfortable sensation or pain in the arm to which the tourniquet is applied. Once pain occurs the tourniquet is released. This will be measured in minutes.

  Pain-free tourniquet time; from the time of tourniquet inflation until the patient experiences tourniquet pain, whichever occurs first

Study Arms (2)

Forearm Nerve Block

EXPERIMENTAL

Patients will receive a nerve block of the radial, median, and ulnar nerves at the level of the forearm using 1% lidocaine with epinephrine. The lidocaine will be injected subcutaneously, using a total dose of less than 7mg per kilogram.

Procedure: Forearm nerve block

Local Anesthetic Infiltration

ACTIVE COMPARATOR

Patients will receive local anesthetic infiltration, using 1% lidocaine with epinephrine, to the fracture site and surrounding tissue. No nerve blocks will be performed. The lidocaine will be injected subcutaneously, using a total dose of less than 7mg per kilogram.

Procedure: Local anesthetic infiltration

Interventions

Forearm nerve block PROCEDURE

Local anesthesia will be used to perform a forearm block of the median, radial, and ulnar nerves.

Forearm Nerve Block

Local anesthetic infiltration PROCEDURE

Local anesthesia will be infiltrated at the site of injury

Local Anesthetic Infiltration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English speaking
• years of age or older at time of enrollment
• are scheduled to undergo a minor hand surgery under local anesthesia

You may not qualify if:

• Patients with known allergies or intolerance to local anesthetic agents
• Patients with known chronic pain disorders or peripheral neuropathies
• Pediatric patients (\<18 years of age) at the time of enrollment
• Patients with a history of opioid (or other pain medication) substance use disorders

Sponsors & Collaborators

• University of Manitoba: lead

Related Publications (10)

• Feehan LM, Sheps SB. Incidence and demographics of hand fractures in British Columbia, Canada: a population-based study. J Hand Surg Am. 2006 Sep;31(7):1068-74. doi: 10.1016/j.jhsa.2006.06.006.

  PMID: 16945705 BACKGROUND

• Gillis JA, Williams JG. Cost analysis of percutaneous fixation of hand fractures in the main operating room versus the ambulatory setting. J Plast Reconstr Aesthet Surg. 2017 Aug;70(8):1044-1050. doi: 10.1016/j.bjps.2017.05.011. Epub 2017 May 20.

  PMID: 28572044 BACKGROUND

• Steve AK, Schrag CH, Kuo A, Harrop AR. Metacarpal Fracture Fixation in a Minor Surgery Setting Versus Main Operating Room: A Cost-minimization Analysis. Plast Reconstr Surg Glob Open. 2019 Jul 5;7(7):e2298. doi: 10.1097/GOX.0000000000002298. eCollection 2019 Jul.

  PMID: 31942336 BACKGROUND

• Thompson NB, Calandruccio JH. Hand Surgery in the Ambulatory Surgery Center. Orthop Clin North Am. 2018 Jan;49(1):69-72. doi: 10.1016/j.ocl.2017.08.009.

  PMID: 29145986 BACKGROUND

• Peters B, Giuffre JL. Canadian Trends in Carpal Tunnel Surgery. J Hand Surg Am. 2018 Nov;43(11):1035.e1-1035.e8. doi: 10.1016/j.jhsa.2018.02.014. Epub 2018 Mar 17.

  PMID: 29559326 BACKGROUND

• Dekoninck V, Hoydonckx Y, Van de Velde M, Ory JP, Dubois J, Jamaer L, Jalil H, Stessel B. The analgesic efficacy of intravenous regional anesthesia with a forearm versus conventional upper arm tourniquet: a systematic review. BMC Anesthesiol. 2018 Jul 18;18(1):86. doi: 10.1186/s12871-018-0550-4.

  PMID: 30021514 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

• Farbood A, Khademi S, Tajvidi R, Hooshangi M, Salari S, Ghani M, Tahmasebi S, Jamali H. Comparison of Intravenous Regional Anesthesia with Single-Cuff Forearm Tourniquet and Hematoma Block and Traditional Method in Patients with Distal Radius Fractures; A Randomized Clinical Trial. Bull Emerg Trauma. 2020 Apr;8(2):77-82. doi: 10.30476/BEAT.2020.46446.

  PMID: 32420391 BACKGROUND

• Winter J, McLeod G, Quaife T, Petropolis C. Surgeon-administered Ultrasound-guided Peripheral Nerve Blocks in Outpatient Procedures of the Upper Extremity. Plast Reconstr Surg Glob Open. 2020 Nov 24;8(11):e3227. doi: 10.1097/GOX.0000000000003227. eCollection 2020 Nov.

  PMID: 33299698 BACKGROUND

• Lovely LM, Chishti YZ, Woodland JL, Lalonde DH. How Much Volume of Local Anesthesia and How Long Should You Wait After Injection for an Effective Wrist Median Nerve Block? Hand (N Y). 2018 May;13(3):281-284. doi: 10.1177/1558944717709072. Epub 2017 May 26.

  PMID: 28549398 BACKGROUND

MeSH Terms

Conditions

Hand Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Christian Petropolis, MD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Justine Ring, MD

CONTACT

12045574324; jring@qmed.ca

Jessica Winter, MD

CONTACT

306-530-1032; winterj3@myumanitoba.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The study will be open-label as both the patient and resident/surgeon will be aware of the type of block (forearm vs local) performed.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor and Residency Program Director, Department of Surgery

Model Details: Patients who consent to participation will then be randomized using a random number generator to receive either a forearm nerve block or local anesthetic infiltration, there will be 20 patients assigned to each group.

Study Record Dates

• First Submitted: March 2, 2021
• First Posted: March 9, 2021
• Study Start: December 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: May 1, 2023
• Last Updated: November 29, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Information will be made available from the end of the study period, for one calendar year after publication of our results, upon request.
• Access Criteria: We are currently working with our institutional library to formalize how this data will be shared.