NCT04549441

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 9, 2018

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 16, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

September 21, 2020

Status Verified

September 1, 2020

Enrollment Period

2.1 years

First QC Date

September 8, 2020

Last Update Submit

September 17, 2020

Conditions

WALANTRadius Fracture Distal

Keywords

WALANTWide-awake local anesthesia no tourniquetWide-awake hand surgeryDistal radius fractureAnesthesia

Outcome Measures

Primary Outcomes (2)

  • Blood pressure

    Intraoperative mean arterial pressure

    The outcome will be measured intraoperatively.

  • Heart rate

    Intraoperative heart rate

    The outcome will be measured intraoperatively.

Secondary Outcomes (1)

  • 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).

Study Arms (2)

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

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

Interventions

Distal radius fracture plating surgeryPROCEDURE

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

GAWALANT

Eligibility Criteria

Age20 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with a mature skeleton having a radial fracture

You may qualify if:

  • Patients with a mature skeleton having a radial fracture

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Municipal Siaogang Hospital

Kaohsiung City, 812, Taiwan

RECRUITING

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, Bone

Study Officials

  • Wen-Chih Liu, MD

    Kaohsiung Municipal Siaogang Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Li-Ru Fang

CONTACT

886-7-8036783870725@kmuh.org.tw

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending surgeon

Study Record Dates

First Submitted

September 8, 2020

First Posted

September 16, 2020

Study Start

November 9, 2018

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

September 21, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)