Clinical trial NCT04549441: Prospective Observational Study Comparing GA and WALANT in Distal Radius Fracture Plating Surgery
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: WALANT
Radius Fracture Distal
Keywords: WALANT
Wide-awake local anesthesia no tourniquet
Wide-awake hand surgery
Distal radius fracture
Anesthesia
Lead sponsor: Kaohsiung Medical University
Sponsor class: OTHER
First posted: 2020-09-16
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a mature skeleton having a radial fracture

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.

Eligibility criteria: 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

Primary outcomes:
measure: Blood pressure
timeFrame: The outcome will be measured intraoperatively.
measure: Heart rate
timeFrame: The outcome will be measured intraoperatively.
Secondary outcomes:
measure: Pain scale
timeFrame: 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).
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Municipal Siaogang Hospital
Study officials:
affiliation: Kaohsiung Municipal Siaogang Hospital
name: Wen-Chih Liu, MD
role: PRINCIPAL_INVESTIGATOR
References: