WALANTNCT04549441
Prospective Observational Study Comparing GA and WALANT in Distal Radius Fracture Plating Surgery
An observational study of WALANT and Radius Fracture Distal, run by Kaohsiung Medical University at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 99 years
- Conditions the study is for
- WALANT, Radius Fracture Distal
- What is being tested?
- Distal radius fracture plating surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 9 Nov 2018to 31 Dec 2020
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a mature skeleton having a radial fracture
Who may be able to join
- Patients with a mature skeleton having a radial fracture
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Kaohsiung Municipal Siaogang Hospital
Kaohsiung City, 812
Wen-Chih Liu, MD, 886-7-803-6783 ext. 3475, 1020429@kmuh.org.tw
Wen-Chih Liu, MD
About this study
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
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.
Read the detailed description
- Written informed consent must be obtained before any study-specific procedures are undertaken.
- 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.
- 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.
- Conditions
- WALANT, Radius Fracture Distal
- Being tested
- Distal radius fracture plating surgery
- Keywords
- WALANT, Wide-awake local anesthesia no tourniquet, Wide-awake hand surgery, Distal radius fracture, Anesthesia
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distal radius fracture plating surgeryProcedure or surgery
We performed open reduction and plating surgery for the distal radius fracture.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Procedure: Distal radius fracture plating surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
Intraoperative mean arterial pressure
Measured: The outcome will be measured intraoperatively.
Heart rate
Intraoperative heart rate
Measured: The outcome will be measured intraoperatively.
Secondary outcomes (1)
Pain scale
Numeric rating scale (NRS) for pain
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start9 Nov 2018
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WALANTStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Kaohsiung Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wen-Chih Liu, Kaohsiung Municipal Hsiaokang Hospital
- Investigators
- Wen-Chih Liu, MD, Principal investigator, Kaohsiung Municipal Siaogang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04549441
- Sponsor's protocol ID
- KMUHIRB-F(I)-20180116
- Status last verified
- Sep 2020
- First submitted
- 8 Sep 2020
- Last updated
- 21 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04549441
- Acronym / sponsor ID
- KMUHIRB-F(I)-20180116
- Conditions
- WALANT, Radius Fracture Distal
- Keywords
- WALANT, Wide-awake local anesthesia no tourniquet, Wide-awake hand surgery, Distal radius fracture, Anesthesia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kaohsiung Medical UniversityUniversity, hospital or other
- Study start
- 9 Nov 2018 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 16 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Written informed consent must be obtained before any study-specific procedures are undertaken.
- 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.
- 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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WALANT | – | Procedure: Distal radius fracture plating surgeryThe 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). |
| GA | – | Procedure: Distal radius fracture plating surgeryThe 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. |
Who may qualify
- Ages
- 20 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a mature skeleton having a radial fracture
Key inclusion criteria (1 listed)
- Patients with a mature skeleton having a radial fracture
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Distal radius fracture plating surgeryWe performed open reduction and plating surgery for the distal radius fracture. | Procedure or surgery | GA, WALANT |
Primary outcome
Blood pressure
Time frame: The outcome will be measured intraoperatively.
Intraoperative mean arterial pressure
Heart rate
Time frame: The outcome will be measured intraoperatively.
Intraoperative heart rate
1 secondary outcome
Pain scale
Time frame: 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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wen-Chih Liu, MD principal investigator
Kaohsiung Municipal Siaogang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of WALANT and Radius Fracture Distal, run by Kaohsiung Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li-Ru Fang (886-7-8036783 ext. 3475, 870725@kmuh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure (time frame: The outcome will be measured intraoperatively.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2020.