Radius Fracture DistalNCT05421000
WALANT in Distal Radius Fracture Osteosynthesis
A study testing WALANT and Locoregional anesthesia and tourniquet in people with Radius Fracture Distal, run by Hospital Arnau de Vilanova at 1 site in Spain.
Trial summary
The purpose of this study is to assess the applicability and potential benefits of Wide Awake Local Anesthesia No Tourniquet (WALANT) or Local Anesthesia No Tourniquet ("LANT) versus locoregional anesthesia (LRA) and tourniquet in osteosynthesis of distal radius fractures (DRF) during the immediate postoperative… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Radius Fracture Distal
- What is being tested?
- WALANT and Locoregional anesthesia and tourniquet
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteSpain
- Study dates
- 20 Dec 2020to 31 Dec 2021
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who attended our hospital from December 2020th to December 2021 with DRF requiring surgical treatment who provided written informed consent and did not have any of the following excluding conditions described below
Who cannot join
- Unsigned informed consent
- 17 years old or younger
- Associated fractures in which additional osteosynthesis was required: scaphoid fracture, ulnar fracture (ulnar styloid osteosynthesis included), bifocal radius fractures, etc
- Open fractures
- Polytrauma patients
- Requiring more than a standard volar DRF approach and/or other than a volar plate.
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- DRF with >30 days or DRF malunions Contraindications to the use of ischemia
- Peripheral vascular disease b. Extensive soft tissue injury c. Peripheral neuropathy d. Severe infection e. Thromboembolic disease in the extremity f. Poor skin conditions g. Arteriovenous fistula h. Sickle cell hemoglobinopathy
- Contraindications for proximal blocking:
- Existence of previous trauma or anatomical distortion of the area that prevents the abduction of the arm
- Active presence of infection at the locoregional anesthesia puncture site
- Previous axillary lymphadenopathy
- Previous history of local anesthetic allergy
- Severe coagulopathy
- Severe pre-existing neurological diseases in the upper extremity
- Contraindications for WALANT anesthetic technique
- Documented hypersensitivity to lidocaine
- Compromised peripheral circulation
- Patients with previous vascular pathology, a history of vasculitis, Buerger's disease, and scleroderma
- Patients with infection of the area surrounding the injection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing the Applicability and Potential Benefits of Wide Awake Local Anaesthesia No Tourniquet in Distal Radius Fracture Osteosynthesis.
The purpose of this study is to assess the applicability and potential benefits of Wide Awake Local Anesthesia No Tourniquet (WALANT) or Local Anesthesia No Tourniquet ("LANT) versus locoregional anesthesia (LRA) and tourniquet in osteosynthesis of distal radius fractures (DRF) during the immediate postoperative period. Our hypothesis is that being able to avoid the use of a limb tourniquet in such a procedure may cause less swelling and better surgical wound appearance in the immediate postoperative period, without compromising pain level, patient satisfaction, or improving the number of complications. In this regard, prospective randomized study was designed comparing short term results of patients who were operated using WALANT (A) to locoregional anesthesia (LRA) and tourniquet (B). Main outcomes were pain, swelling and patient satisfaction. Surgical wound bleeding,mobility, surgeon's technical difficulty, insufficient anesthesia and complications were also evaluated.
- Conditions
- Radius Fracture Distal
- Being tested
- WALANT, Locoregional anesthesia and tourniquet
- Keywords
- Radius Fracture Distal, Local Anesthesia, Brachial Plexus Anesthesia, Osteosynthesis, Fracture
- Medical subject headings
- Wrist Fractures, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WALANTProcedure or surgery
Wide awake local anesthesia without tourniquet for distal radius fracture surgery
Locoregional anesthesia and tourniquetProcedure or surgery
Locoregional anesthesia and tourniquet for distal radius fracture surgery
| Study group | Role | What they receive |
|---|---|---|
| WALANT | Experimental | Wide awake local anesthesia without tourniquet was used for surgery Receives: Procedure: WALANT |
| Locoregional anesthesia and tourniquet | Active comparator | Locoregional anesthesia (normally axillary block) and tourniquet was used for surgery Receives: Procedure: Locoregional anesthesia and tourniquet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change between baseline patient's pain, immediately after the intervention, 24 hours after surgery, between 10 or 15 days after surgery and at 1 month after surgery
Pain using Visual Analogue Scale (VAS) scale and analgesia used (1 to 10 score. 10 means worst pain possible, 1 is almost no pain)
Measured: Baseline, 24 hours after surgery, between 10 and 15 days after surgery, 1 month follow up
Change in baseline wrist swelling with 24 hours after surgery, between 10 or 15 days after surgery and at 1 month after surgery.
Difference between preoperative and postoperative swelling. Swelling was measured as Proximal wrist crease perimeter (cm). Healthy wrist was also measured to allow comparison.
Measured: Baseline, 24 hours after surgery, between 10 and 15 days after surgery, 1 month follow up
Patient satisfaction
Index of satisfaction, willingness to repeat and recommend the anesthetic technique. Personal designed "Satisfaction" scale (1 no satisfied- 5 very satisfied); 2 questions about whether he/she would repeat and recommend the anesthesia received (Yes/No answer)
Measured: Written down in a questionnaire form delivered and answered by the patient between 10 and 15 days after surgery.
Secondary outcomes (12)
Evolution of active bleeding through surgical wound after surgery
Presence of active bleeding through the surgical wound
Measured: 24 hours after surgery, between 10 and 15 days after surgery, 1 month follow up
Evolution in postoperative thumb mobility
Kapandji scale for thumb mobility (1 to 10 scale. 10 represents the best thumb mobility and opposition possible, while 1 is almost no mobility)
Measured: 24 hours after surgery, between 10 and 15 days after surgery, 1 month follow up
Difficulty in visualization of surgical field
Asked by the external observer to the surgeon right after the surgery had finished. Personal scale (1 easy- 5 very difficult)
Measured: During surgery
Stress during surgery
asked by the external observer to the surgeon right after the surgery had finished. Yes/no question and description of the reason of stress if any.
Measured: During surgery
Number of complications after surgery
Description of complications regarding surgery or anesthetical technique
Measured: Collected at end of follow up (1 month)
Evolution in postoperative finger mobility
Capability to reach the distal and the proximal palmar crease with the tip of the fingers, named after 1st line and 2nd line respectively (according to intrinsic and extrinsic movement). If not arrived, the investigator's used the number of the observer's finger widths left to arrive each crease (i.e. 1 finger widths, 2 fingers widths)
Measured: 24 hours after surgery, between 10 and 15 days after surgery, 1 month follow up
Evolution of surgical wound bleeding after surgery
Amount of blood encountered in the dressings (measured as on third, two thirds or more than two thirds of blood within the whole dressing/gauge)
Measured: 24 hours after surgery, between 10 and 15 days after surgery, 1 month follow up
Evolution in postoperative wrist mobility
Flexion, extension, radial and ulnar deviation, pronation and supination using a goniometer (º)
Measured: 24 hours after surgery, between 10 and 15 days after surgery, 1 month follow up
Number of patients who need reconversion to general anaesthesia due to lack of effectiveness of anaesthetic technique
Yes or no answer to the question "does the patient need reconversion to general anaesthesia?"
Measured: During surgery
Number of patients who need adding some extra anaesthesia due to lack of effectiveness of anaesthetic technique
Yes or no answer to the question "does the patient need extra anaesthesia?"
Measured: During surgery
Description of reason why the patient needs adding some extra anaesthesia if necessary due to lack of effectiveness of the main anaesthetic technique
Open answer question describing the reason of anaesthesia insufficiency (for instance: pain, anxiety, discomfort, etc)
Measured: During surgery
Type of anaesthetic technique added to solve the lack of effectiveness of the main anaesthesia
Open answer question describing the technique used in order to resolve lack of anaesthesia if needed (sedation, extra doses of local anaesthetic, anatomic location of local anaesthetic, doses of local anaesthetic, etc)
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2022
- Study start20 Dec 2020
- Primary completion22 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radius Fracture DistalStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients who had a surgical distal radius fracture, met all the inclusion criteria and signed the informed consent were randomized either to Group A in which WALANT technique was performed or Group B in which locoregional anesthesia(LRA) and upper limb tourniquet was used. This process was done by the external observer with 10 block randomization. Blinding was not possible as the differences between the anesthetic techniques are evident. However, none of the patients nor the surgeon or the anesthesiologist knew the group of intervention until the patient arrived at the operating anteroom the same day of surgery. Since the investigators considered this was a complex intervention, all patients were offered to receive sedation from the anesthesiologist if they presented any level of anxiety.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Arnau de Vilanova
- Sponsor type
- University, hospital or other
- Collaborators
- Institut de Recerca Biomèdica de Lleida
- Responsible party
- Principal investigator, Ana Scott-Tennent, Hospital Arnau de Vilanova
- Investigators
- Ana Scott-Tennent, Miss, Principal investigator, Hospital Arnau Vilanova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05421000
- Sponsor's protocol ID
- CEIC-2360
- Status last verified
- Jun 2022
- First submitted
- 1 Jun 2022
- Last updated
- 16 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 16 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Applicability and Potential Benefits of Wide Awake Local Anaesthesia No Tourniquet in Distal Radius Fracture Osteosynthesis.
- ClinicalTrials.gov ID
- NCT05421000
- Acronym / sponsor ID
- CEIC-2360
- Conditions
- Radius Fracture Distal
- Keywords
- Radius Fracture Distal, Local Anesthesia, Brachial Plexus Anesthesia, Osteosynthesis, Fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Hospital Arnau de VilanovaUniversity, hospital or other
- Collaborators
- Institut de Recerca Biomèdica de Lleida
- Study start
- 20 Dec 2020 (actual)
- Primary completion
- 22 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 16 Jun 2022 (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 purpose of this study is to assess the applicability and potential benefits of Wide Awake Local Anesthesia No Tourniquet (WALANT) or Local Anesthesia No Tourniquet ("LANT) versus locoregional anesthesia (LRA) and tourniquet in osteosynthesis of distal radius fractures (DRF) during the immediate postoperative period. Our hypothesis is that being able to avoid the use of a limb tourniquet in such a procedure may cause less swelling and better surgical wound appearance in the immediate postoperative period, without compromising pain level, patient satisfaction, or improving the number of complications. In this regard, prospective randomized study was designed comparing short term results of patients who were operated using WALANT (A) to locoregional anesthesia (LRA) and tourniquet (B). Main outcomes were pain, swelling and patient satisfaction. Surgical wound bleeding,mobility, surgeon's technical difficulty, insufficient anesthesia and complications were also evaluated.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Patients who had a surgical distal radius fracture, met all the inclusion criteria and signed the informed consent were randomized either to Group A in which WALANT technique was performed or Group B in which locoregional anesthesia(LRA) and upper limb tourniquet was used. This process was done by the external observer with 10 block randomization. Blinding was not possible as the differences between the anesthetic techniques are evident. However, none of the patients nor the surgeon or the anesthesiologist knew the group of intervention until the patient arrived at the operating anteroom the same day of surgery. Since the investigators considered this was a complex intervention, all patients were offered to receive sedation from the anesthesiologist if they presented any level of anxiety.
| Arm | Type | Receives |
|---|---|---|
| WALANT | Experimental | Procedure: WALANTWide awake local anesthesia without tourniquet was used for surgery |
| Locoregional anesthesia and tourniquet | Active comparator | Procedure: Locoregional anesthesia and tourniquetLocoregional anesthesia (normally axillary block) and tourniquet was used for surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who attended our hospital from December 2020th to December 2021 with DRF requiring surgical treatment who provided written informed consent and did not have any of the following excluding conditions described below
Key exclusion criteria (20 listed)
- Unsigned informed consent
- 17 years old or younger
- Associated fractures in which additional osteosynthesis was required: scaphoid fracture, ulnar fracture (ulnar styloid osteosynthesis included), bifocal radius fractures, etc
- Open fractures
- Polytrauma patients
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 |
|---|---|---|
| WALANTWide awake local anesthesia without tourniquet for distal radius fracture surgery | Procedure or surgery | WALANT |
| Locoregional anesthesia and tourniquetLocoregional anesthesia and tourniquet for distal radius fracture surgery | Procedure or surgery | Locoregional anesthesia and tourniquet |
Primary outcome
Change between baseline patient's pain, immediately after the intervention, 24 hours after surgery, between 10 or 15 days after surgery and at 1 month after surgery
Time frame: Baseline, 24 hours after surgery, between 10 and 15 days after surgery, 1 month follow up
Pain using Visual Analogue Scale (VAS) scale and analgesia used (1 to 10 score. 10 means worst pain possible, 1 is almost no pain)
Change in baseline wrist swelling with 24 hours after surgery, between 10 or 15 days after surgery and at 1 month after surgery.
Time frame: Baseline, 24 hours after surgery, between 10 and 15 days after surgery, 1 month follow up
Difference between preoperative and postoperative swelling. Swelling was measured as Proximal wrist crease perimeter (cm). Healthy wrist was also measured to allow comparison.
Patient satisfaction
Time frame: Written down in a questionnaire form delivered and answered by the patient between 10 and 15 days after surgery.
Index of satisfaction, willingness to repeat and recommend the anesthetic technique. Personal designed "Satisfaction" scale (1 no satisfied- 5 very satisfied); 2 questions about whether he/she would repeat and recommend the anesthesia received (Yes/No answer)
12 secondary outcomes
Evolution of active bleeding through surgical wound after surgery
Time frame: 24 hours after surgery, between 10 and 15 days after surgery, 1 month follow up
Evolution in postoperative thumb mobility
Time frame: 24 hours after surgery, between 10 and 15 days after surgery, 1 month follow up
Difficulty in visualization of surgical field
Time frame: During surgery
Stress during surgery
Time frame: During surgery
Number of complications after surgery
Time frame: Collected at end of follow up (1 month)
Evolution in postoperative finger mobility
Time frame: 24 hours after surgery, between 10 and 15 days after surgery, 1 month follow up
Evolution of surgical wound bleeding after surgery
Time frame: 24 hours after surgery, between 10 and 15 days after surgery, 1 month follow up
Evolution in postoperative wrist mobility
Time frame: 24 hours after surgery, between 10 and 15 days after surgery, 1 month follow up
Number of patients who need reconversion to general anaesthesia due to lack of effectiveness of anaesthetic technique
Time frame: During surgery
Number of patients who need adding some extra anaesthesia due to lack of effectiveness of anaesthetic technique
Time frame: During surgery
Description of reason why the patient needs adding some extra anaesthesia if necessary due to lack of effectiveness of the main anaesthetic technique
Time frame: During surgery
Type of anaesthetic technique added to solve the lack of effectiveness of the main anaesthesia
Time frame: During surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2022.
- 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.
Ana Scott-Tennent, Miss principal investigator
Hospital Arnau Vilanova
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WALANT and Locoregional anesthesia and tourniquet in people with Radius Fracture Distal, run by Hospital Arnau de Vilanova at 1 site in Spain.
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 20 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: finished, as of the sponsor's last update on 16 Jun 2022. 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change between baseline patient's pain, immediately after the intervention, 24 hours after surgery, between 10 or 15 days after surgery and at 1 month after surgery (time frame: Baseline, 24 hours after surgery, between 10 and 15 days after surgery, 1 month follow up). The study lists 3 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 16 Jun 2022.