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

• Conditions: WALANT; Radius Fracture Distal

• Registration Number: NCT04549441
• Lead Sponsor: Kaohsiung Medical University

Brief Summary

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.

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 Timeline

• Study Start: 2018-11-09
• Status Verified: 2020-09
• Study First Submitted: 2020-09-08
• Study First Submitted QC: 2020-09-08
• Study First Posted: 2020-09-16
• Last Update Submitted: 2020-09-17
• Last Update Posted: 2020-09-21
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Heart rate	The outcome will be measured intraoperatively.	Intraoperative heart rate
Blood pressure	The outcome will be measured intraoperatively.	Intraoperative mean arterial pressure

Secondary Outcome Measures

Name	Time	Method
Pain scale	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).	Numeric rating scale (NRS) for pain

Trial Locations

Locations (1)

Kaohsiung Municipal Siaogang Hospital; 🇨🇳 Kaohsiung, Taiwan