Prospective Observational Study Comparing GA and WALANT in Distal Radius Fracture Plating Surgery

Prospective Observational Study Comparing General Anesthesia and Wide-Awake Anesthesia No Tourniquet (WALANT) for Distal Radius Fracture Open Reduction and Plating Fixation Surgery

The wide-awake local anesthesia no tourniquet (WALANT) has been widely used in the field of hand surgery in recent years. This surgical method has progressed to open reduction and internal fixation of distal radial fracture and radial or ulnar shaft fractures. However, there are still many unclear points for clinicians, including the perioperative subjective feedback from the patient and changes in postoperative pain. In this study, participants having forearm fractures should undergo open reduction and internal fixation were randomized to general anesthesia or WALANT. The investigators will compare the differences in perioperative subjective and objective assessments of these participants during surgery, as well as the prognosis and function after surgery.

Study Overview

• Status: Unknown
• Conditions: Radius Fracture Distal; WALANT
• Intervention / Treatment: Procedure: Distal radius fracture plating surgery

Detailed Description

1. Written informed consent must be obtained before any study-specific procedures are undertaken.
2. The process of the experiment A. Include participants into this study, they will be randomized into general anesthesia or WALANT group B. The maximum (toxic) dose of lidocaine was 7 mg/kg. Make distal radius fracture for an example, the solution used in the WALANT technique consisted of 20 ml of 2% lidocaine with epinephrine 1:50,000, which were mixed with normal saline to give a total of 40 ml. A set of baseline parameters, including pulse oximetry, respiratory rate, heart rate, blood pressure, respiratory rate, and oxygen saturation, was obtained during the entire surgery. At the same time, preoperative intravenous antibiotics with 1 g cefazolin were given for each patient as prophylaxis. The amount of blood loss was based upon the amount in a suction container in the operation room. In addition, the investigators will measure the participant's intraoperative subjective satisfaction and pain assessment.

C. After surgery, the participant needs to stay in the in-patient department for one day. The investigators will provide routine prophylactic antibiotics and oral pain pillar. Postoperative pain, sensory, and motor function assessment.

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

Study Locations

• Taiwan
  • Kaohsiung, Taiwan, 812
    • Recruiting
    • Kaohsiung Municipal Siaogang Hospital
    • Contact: Wen-Chih Liu, MD; Phone Number: 3475 886-7-803-6783; Email: 1020429@kmuh.org.tw
    • Principal Investigator: Wen-Chih Liu, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with a mature skeleton having a radial fracture

Description

Inclusion Criteria:

• Patients with a mature skeleton having a radial fracture

Exclusion Criteria:

• Patients having multiple trauma and need to undergo open reduction and internal fixation surgery
• Patients having a concomitant intracranial injury
• Pathological fracture
• Patients refused to be randomized into general anesthesia or WALANT group
• Patients have a history of allergy to anesthetic drugs

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
WALANT; The participants undergo distal radius plating surgery via wide-awake local anesthesia no tourniquet technique. In this group, mean arterial pressure, heart rate, and numeric rating scale for pain were measured by nursing staff in the operation theatre seven times perioperatively, namely before surgery (T0) and at the time of injection of local anesthesia (T1), skin incision (T2), fracture reduction (T3), plating and screwing (T4), skin closure (T5), surgery completion (T6).	Procedure: Distal radius fracture plating surgery; We performed open reduction and plating surgery for the distal radius fracture.
GA; The participants undergo distal radius plating surgery via general anesthesia induced by an anesthesiologist. The anesthesia team continuously monitored patients' intraoperative physiological status. MAP and HR in group B were marked after induction (T1) and at the other six same time points as in the group WALANT.	Procedure: Distal radius fracture plating surgery; We performed open reduction and plating surgery for the distal radius fracture.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure	Intraoperative mean arterial pressure	The outcome will be measured intraoperatively.
Heart rate	Intraoperative heart rate	The outcome will be measured intraoperatively.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain scale	Numeric rating scale (NRS) for pain	The NRS was recorded in seven times perioperativley, namely before surgery (T0) and at the time of injection of local anesthesia (T1), skin incision (T2), fracture reduction (T3), plating and screwing (T4), skin closure (T5), and surgery completion (T6).

Collaborators and Investigators

• Sponsor: Kaohsiung Medical University
• Investigators: Principal Investigator: Wen-Chih Liu, MD, Kaohsiung Municipal Siaogang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2018
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: September 8, 2020
• First Submitted That Met QC Criteria: September 8, 2020
• First Posted (Actual): September 16, 2020

Study Record Updates

• Last Update Posted (Actual): September 21, 2020
• Last Update Submitted That Met QC Criteria: September 17, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Anesthesia; Distal radius fracture; WALANT; Wide-awake local anesthesia no tourniquet; Wide-awake hand surgery
• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Forearm Injuries; Fractures, Bone; Radius Fractures
• Other Study ID Numbers: KMUHIRB-F(I)-20180116

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No