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

Radius Fracture Distal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04549441
• Other study ID #: KMUHIRB-F(I)-20180116
• Status: Recruiting
• Start date: November 9, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: September 2020
• Source: Kaohsiung Medical University
• Contact: Li-Ru Fang
• Phone: 886-7-8036783
• Email: 870725[@]kmuh.org.tw
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Radius Fracture Distal
• Radius Fractures
• WALANT

Intervention

Procedure:
• Distal radius fracture plating surgery
We performed open reduction and plating surgery for the distal radius fracture.

Locations

Country	Name	City	State
Taiwan	Kaohsiung Municipal Siaogang Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood pressure	Intraoperative mean arterial pressure	The outcome will be measured intraoperatively.
Primary	Heart rate	Intraoperative heart rate	The outcome will be measured intraoperatively.
Secondary	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).