Back to resultsWALANT in Distal Radius Fracture Osteosynthesis
Primary Purpose
Radius Fracture Distal
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
WALANT
Locoregional anesthesia and tourniquet
Sponsored by
About this trial
This is an interventional supportive care trial for Radius Fracture Distal focused on measuring Radius Fracture Distal, Local Anesthesia, Brachial Plexus Anesthesia, Osteosynthesis, Fracture
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
- DRF with >30 days or DRF malunions Contraindications to the use of ischemia
a. 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
Sites / Locations
- Hospital Arnau Vilanova
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
WALANT
Locoregional anesthesia and tourniquet
Arm Description
Wide awake local anesthesia without tourniquet was used for surgery
Locoregional anesthesia (normally axillary block) and tourniquet was used for surgery
Outcomes
Primary Outcome Measures
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)
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.
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)
Secondary Outcome Measures
Evolution of active bleeding through surgical wound after surgery
Presence of active bleeding through the surgical wound
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)
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)
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.
Number of complications after surgery
Description of complications regarding surgery or anesthetical technique
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)
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)
Evolution in postoperative wrist mobility
Flexion, extension, radial and ulnar deviation, pronation and supination using a goniometer (º)
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?"
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?"
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)
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)
Full Information
NCT ID
NCT05421000
First Posted
June 1, 2022
Last Updated
June 15, 2022
Sponsor
Hospital Arnau de Vilanova
Collaborators
Institut de Recerca Biomèdica de Lleida
1. Study Identification
Unique Protocol Identification Number
NCT05421000
Brief Title
WALANT in Distal Radius Fracture Osteosynthesis
Official Title
Assessing the Applicability and Potential Benefits of Wide Awake Local Anaesthesia No Tourniquet in Distal Radius Fracture Osteosynthesis.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
December 20, 2020 (Actual)
Primary Completion Date
December 22, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Arnau de Vilanova
Collaborators
Institut de Recerca Biomèdica de Lleida
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radius Fracture Distal
Keywords
Radius Fracture Distal, Local Anesthesia, Brachial Plexus Anesthesia, Osteosynthesis, Fracture
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare Provider
Masking Description
10 block randomization was done by an external observer. Accordingly, the surgeon, the anesthesic or the patient didn't know about intervention until it was time to be exposed to the treatment
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
WALANT
Arm Type
Experimental
Arm Description
Wide awake local anesthesia without tourniquet was used for surgery
Arm Title
Locoregional anesthesia and tourniquet
Arm Type
Active Comparator
Arm Description
Locoregional anesthesia (normally axillary block) and tourniquet was used for surgery
Intervention Type
Procedure
Intervention Name(s)
WALANT
Intervention Description
Wide awake local anesthesia without tourniquet for distal radius fracture surgery
Intervention Type
Procedure
Intervention Name(s)
Locoregional anesthesia and tourniquet
Intervention Description
Locoregional anesthesia and tourniquet for distal radius fracture surgery
Primary Outcome Measure Information:
Title
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
Description
Pain using Visual Analogue Scale (VAS) scale and analgesia used (1 to 10 score. 10 means worst pain possible, 1 is almost no pain)
Time Frame
Baseline, 24 hours after surgery, between 10 and 15 days after surgery, 1 month follow up
Title
Change in baseline wrist swelling with 24 hours after surgery, between 10 or 15 days after surgery and at 1 month after surgery.
Description
Difference between preoperative and postoperative swelling. Swelling was measured as Proximal wrist crease perimeter (cm). Healthy wrist was also measured to allow comparison.
Time Frame
Baseline, 24 hours after surgery, between 10 and 15 days after surgery, 1 month follow up
Title
Patient satisfaction
Description
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)
Time Frame
Written down in a questionnaire form delivered and answered by the patient between 10 and 15 days after surgery.
Secondary Outcome Measure Information:
Title
Evolution of active bleeding through surgical wound after surgery
Description
Presence of active bleeding through the surgical wound
Time Frame
24 hours after surgery, between 10 and 15 days after surgery, 1 month follow up
Title
Evolution in postoperative thumb mobility
Description
Kapandji scale for thumb mobility (1 to 10 scale. 10 represents the best thumb mobility and opposition possible, while 1 is almost no mobility)
Time Frame
24 hours after surgery, between 10 and 15 days after surgery, 1 month follow up
Title
Difficulty in visualization of surgical field
Description
Asked by the external observer to the surgeon right after the surgery had finished. Personal scale (1 easy- 5 very difficult)
Time Frame
During surgery
Title
Stress during surgery
Description
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.
Time Frame
During surgery
Title
Number of complications after surgery
Description
Description of complications regarding surgery or anesthetical technique
Time Frame
Collected at end of follow up (1 month)
Title
Evolution in postoperative finger mobility
Description
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)
Time Frame
24 hours after surgery, between 10 and 15 days after surgery, 1 month follow up
Title
Evolution of surgical wound bleeding after surgery
Description
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)
Time Frame
24 hours after surgery, between 10 and 15 days after surgery, 1 month follow up
Title
Evolution in postoperative wrist mobility
Description
Flexion, extension, radial and ulnar deviation, pronation and supination using a goniometer (º)
Time Frame
24 hours after surgery, between 10 and 15 days after surgery, 1 month follow up
Title
Number of patients who need reconversion to general anaesthesia due to lack of effectiveness of anaesthetic technique
Description
Yes or no answer to the question "does the patient need reconversion to general anaesthesia?"
Time Frame
During surgery
Title
Number of patients who need adding some extra anaesthesia due to lack of effectiveness of anaesthetic technique
Description
Yes or no answer to the question "does the patient need extra anaesthesia?"
Time Frame
During surgery
Title
Description of reason why the patient needs adding some extra anaesthesia if necessary due to lack of effectiveness of the main anaesthetic technique
Description
Open answer question describing the reason of anaesthesia insufficiency (for instance: pain, anxiety, discomfort, etc)
Time Frame
During surgery
Title
Type of anaesthetic technique added to solve the lack of effectiveness of the main anaesthesia
Description
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)
Time Frame
During surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
DRF with >30 days or DRF malunions Contraindications to the use of ischemia
a. 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ana Scott-Tennent, Miss
Organizational Affiliation
Hospital Arnau Vilanova
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Arnau Vilanova
City
Lleida
State/Province
Segria
ZIP/Postal Code
25198
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
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WALANT in Distal Radius Fracture Osteosynthesis
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