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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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04549441
Enrollment
60
Registered
2020-09-16
Start date
2018-11-09
Completion date
2020-12-31
Last updated
2020-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Radius Fracture Distal, WALANT

Keywords

WALANT, Wide-awake local anesthesia no tourniquet, Wide-awake hand surgery, Distal radius fracture, Anesthesia

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.

Interventions

PROCEDUREDistal radius fracture plating surgery

We performed open reduction and plating surgery for the distal radius fracture.

Sponsors

Kaohsiung Medical University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 99 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Blood pressureThe outcome will be measured intraoperatively.Intraoperative mean arterial pressure
Heart rateThe outcome will be measured intraoperatively.Intraoperative heart rate

Secondary

MeasureTime frameDescription
Pain scaleThe 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

Countries

Taiwan

Contacts

Primary ContactLi-Ru Fang
870725@kmuh.org.tw886-7-8036783

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026