Ignite Creation Date:
2024-05-06 @ 3:01 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04494100
Status:
COMPLETED
Last Update Posted:
2021-07-23
First Post:
2020-07-28
Brief Title:
WALANT Technique Wide Awake Local Anesthesia No Tourniquet for Carpal Tunnel Release
Sponsor:
CMC Ambroise Paré
Organization:
CMC Ambroise Paré
Study Overview
Official Title:
WALANT Technique Wide Awake Local Anesthesia No Tourniquet in Association With Analgesic Troncular Blocks at the Wirst for Carpal Tunnel Release
Status:
COMPLETED
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
WALA
Brief Summary:
The carpal tunnel release CTR is now performed almost exclusively under regional anesthesia RA in France RA requires the use of a pneumatic tourniquet to limit blood flow to the operated extremity and create a bloodless surgical field for a clear visualization of the anatomic structures by the surgeon
Multiple approaches to block the brachial plexus can be considered The most common technique is the axillary block BAX that provides complete anesthesia for the patients arm and forearm This technique offers anesthesia not only for the surgical area but also for the root of the arm where the pneumatic tourniquet is placed However this technique have limits the persistence of a motor block in the arm and the forearm that is not compatible with a quick hospital discharge short term ambulatory hospitalization and the need for assistance with dressing and eating after surgery More distal anesthetic techniques are proposed such as the troncular blocks TRONC that avoid motor block of the arm and offer an earlier recovery and autonomy for the patient However they lead to a poor tolerance to the tourniquet due to its application on a non-anesthetized areaThe pain related to the pressure of the tourniquet can occur within the first few minutes of its inflation get worse over time and persist for several minutes after its deflation Therefore TRONC procedure is less often performed compared to the BAX for major surgeries but it remains appropriate for CTR
The Wide Awake Local Anesthesia No Tourniquet WALANT technique is widely used in Canada and has been proposed for hand and wirst minor surgeries WALANT uses a combination of a local anesthetic LA and epinephrine to induce anesthesia and hemostasis in the area of the surgical procedure in order to allow surgeries to be done without the use of tourniquet Epinephrine is a vasoconstrictor agent that reduces blood flow at surgical site This bloodless effect is visualized on the skin by a pale color Thus WALANT can provide a chemical tourniquet and eliminate the pain from a traditional arm tourniquet However this technique is performed with a short-acting LA and does not offer any postoperative analgesia
The association of TRONC using long-acting LA with the WALANT technique could combine the comfort of a surgery without tourniquet to a long-acting analgesia and thus could provide a superior overall comfort
The main objective of this prospective multicentre randomized open-label parallel-group controlled trial is to evaluate the interest of WALANT technique on patient comfort during CTR performed with TRONC compared to the tourniquet
Multiple approaches to block the brachial plexus can be considered The most common technique is the axillary block BAX that provides complete anesthesia for the patients arm and forearm This technique offers anesthesia not only for the surgical area but also for the root of the arm where the pneumatic tourniquet is placed However this technique have limits the persistence of a motor block in the arm and the forearm that is not compatible with a quick hospital discharge short term ambulatory hospitalization and the need for assistance with dressing and eating after surgery More distal anesthetic techniques are proposed such as the troncular blocks TRONC that avoid motor block of the arm and offer an earlier recovery and autonomy for the patient However they lead to a poor tolerance to the tourniquet due to its application on a non-anesthetized areaThe pain related to the pressure of the tourniquet can occur within the first few minutes of its inflation get worse over time and persist for several minutes after its deflation Therefore TRONC procedure is less often performed compared to the BAX for major surgeries but it remains appropriate for CTR
The Wide Awake Local Anesthesia No Tourniquet WALANT technique is widely used in Canada and has been proposed for hand and wirst minor surgeries WALANT uses a combination of a local anesthetic LA and epinephrine to induce anesthesia and hemostasis in the area of the surgical procedure in order to allow surgeries to be done without the use of tourniquet Epinephrine is a vasoconstrictor agent that reduces blood flow at surgical site This bloodless effect is visualized on the skin by a pale color Thus WALANT can provide a chemical tourniquet and eliminate the pain from a traditional arm tourniquet However this technique is performed with a short-acting LA and does not offer any postoperative analgesia
The association of TRONC using long-acting LA with the WALANT technique could combine the comfort of a surgery without tourniquet to a long-acting analgesia and thus could provide a superior overall comfort
The main objective of this prospective multicentre randomized open-label parallel-group controlled trial is to evaluate the interest of WALANT technique on patient comfort during CTR performed with TRONC compared to the tourniquet
Detailed Description:
This is a multicenter prospective randomized open-label study assessing the interest of the association of the WALANT local infiltration technique with analgesic troncular blocks TRONC at the wrist for the endoscopic CTR
This study compares two groups
CONTROL group usual technique TRONC using a long-acting LA Ropivacaine Tourniquet
WALANT group experimental technique TRONC using a long-acting LA Ropivacaine WALANT using a short-term LA Lidocaine epinephrine
RA procedures will be systematically performed under ultrasound guidance 45 min befor surgery Before each procedure a skin disinfection will be carried out using an alcoholic iodine solution The needle approach will be in-plane IP or out-of-plane OOP Efficiency will be assessed before transfer to the operating room
Troncular blocks TRONC Patients will be installed in supine position the arm at 90 of abduction and in external rotation The probe will be positioned to have an axial view of the nerves at the wrist The initial identification of the median nM and ulnar nU nerves will be systematically done before each TRONC The nM will be located on the anterior forearm The nU will be visualized in contact with the ulnar artery in the forearm The operator will inject 3 to 7 mL of Ropivacaine 375 mgml per nerve An infiltration of 2 ml of Ropivacaine 375 mgml will be performed laterally above the flexion fold of the wrist in order to block the branches of the lateral cutaneous nerve of the forearm the terminal sensory branch of the musculocutaneous nerve nMC A 22 Gauge x 50 mm needle will be used for TRONC
WALANT infiltration WALANT group An infiltration of the subcutaneous area in front of the transverse ligament will be performed between the thenar and hypothenar eminences from the flexion fold of the wrist over a length of 5 cm The path of the nM in the palm of the hand will be checked before each procedure 3 to 7 ml of 1 lidocaine 10 mgml combined with 0005 mgml epinephrine and 84 sodium bicarbonate 1 ml per 10 ml of lidocaine will be injected The addition of sodium bicarbonate will reduce the pain due to lidocaine injection A 24 Gauge x 50 mm needle will be used for WALANT
Usage of pneumatic Tourniquet A pneumatic tourniquet will be placed at the root of the arm in all patients A cuff with size and shape adapted to the patient will be used The tourniquet will be inflated in all patients of CONTROL group and if necessary corresponding to the failure of the WALANT technique in patients of WALANT group The inflation pressure will be determined according to the patients systolic blood pressure SBP It will be inflated 75 to 100 mmHg above SBP
This study compares two groups
CONTROL group usual technique TRONC using a long-acting LA Ropivacaine Tourniquet
WALANT group experimental technique TRONC using a long-acting LA Ropivacaine WALANT using a short-term LA Lidocaine epinephrine
RA procedures will be systematically performed under ultrasound guidance 45 min befor surgery Before each procedure a skin disinfection will be carried out using an alcoholic iodine solution The needle approach will be in-plane IP or out-of-plane OOP Efficiency will be assessed before transfer to the operating room
Troncular blocks TRONC Patients will be installed in supine position the arm at 90 of abduction and in external rotation The probe will be positioned to have an axial view of the nerves at the wrist The initial identification of the median nM and ulnar nU nerves will be systematically done before each TRONC The nM will be located on the anterior forearm The nU will be visualized in contact with the ulnar artery in the forearm The operator will inject 3 to 7 mL of Ropivacaine 375 mgml per nerve An infiltration of 2 ml of Ropivacaine 375 mgml will be performed laterally above the flexion fold of the wrist in order to block the branches of the lateral cutaneous nerve of the forearm the terminal sensory branch of the musculocutaneous nerve nMC A 22 Gauge x 50 mm needle will be used for TRONC
WALANT infiltration WALANT group An infiltration of the subcutaneous area in front of the transverse ligament will be performed between the thenar and hypothenar eminences from the flexion fold of the wrist over a length of 5 cm The path of the nM in the palm of the hand will be checked before each procedure 3 to 7 ml of 1 lidocaine 10 mgml combined with 0005 mgml epinephrine and 84 sodium bicarbonate 1 ml per 10 ml of lidocaine will be injected The addition of sodium bicarbonate will reduce the pain due to lidocaine injection A 24 Gauge x 50 mm needle will be used for WALANT
Usage of pneumatic Tourniquet A pneumatic tourniquet will be placed at the root of the arm in all patients A cuff with size and shape adapted to the patient will be used The tourniquet will be inflated in all patients of CONTROL group and if necessary corresponding to the failure of the WALANT technique in patients of WALANT group The inflation pressure will be determined according to the patients systolic blood pressure SBP It will be inflated 75 to 100 mmHg above SBP
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None