Ignite Creation Date:
2024-05-06 @ 3:52 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04787835
Status:
NOT_YET_RECRUITING
Last Update Posted:
2022-11-29
First Post:
2021-03-02
Brief Title:
The Effect of Forearm Nerve Blocks on Pain-free Tourniquet Time Compared to Local Anesthetic for Awake Hand Surgery
Sponsor:
University of Manitoba
Organization:
University of Manitoba
Study Overview
Official Title:
The Effect of Forearm Nerve Blocks on Pain-free Tourniquet Time Compared to Local Anesthetic for Awake Hand Surgery
Status:
NOT_YET_RECRUITING
Status Verified Date:
2022-11
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:
None
Brief Summary:
Wide-awake surgery with local anesthesia is a widely described approach to performing numerous minor hand procedures such as tendon repairs and percutaneous fracture pinning but is less frequently used for longer procedures such as open reduction internal fixation ORIF This is in part due to the need for a tourniquet for improved visualization however pain-free tourniquet time with local anesthesia is roughly 20 minutes shorter than the average time for ORIFs Gillis for example While general anesthesia may still be avoided with more proximal blocks such as a brachial plexus or bier blocks these still require presence of an anesthesiologist during the procedure increasing human resource utilization and costs Development of an anesthetic technique for hand surgery which could be performed by surgeons in a clinic setting that still provides sufficiently long pain-free tourniquet times could decreases costs and wait times
The investigators hypothesize that the pain patients experience after 20 minutes of tourniquet application with local anesthetic infiltration is not due to direct pressure on the proximal arm but rather distal digital ischemia pain Previously it has been shown that ultrasound-guided regional block of the median radial and ulnar nerves in the forearm is effective analgesia for awake hand surgery Winter
Currently there are no randomized studies investigating if forearm nerve blocks can prolong pain-free tourniquet time compared to local anesthesia infiltration by blocking this ischemic pain in the distal arm The investigators objective is therefore to determine if forearm nerve blocks prolong pain-free tourniquet time compared to local anesthetic infiltration
The investigators hypothesize that the pain patients experience after 20 minutes of tourniquet application with local anesthetic infiltration is not due to direct pressure on the proximal arm but rather distal digital ischemia pain Previously it has been shown that ultrasound-guided regional block of the median radial and ulnar nerves in the forearm is effective analgesia for awake hand surgery Winter
Currently there are no randomized studies investigating if forearm nerve blocks can prolong pain-free tourniquet time compared to local anesthesia infiltration by blocking this ischemic pain in the distal arm The investigators objective is therefore to determine if forearm nerve blocks prolong pain-free tourniquet time compared to local anesthetic infiltration
Detailed Description:
With increasing caseloads in some healthcare systems patients requiring hand surgery may wait over two weeks for time in the general operating room schedule During this time fractures may heal or tendons may retract leading to a need for more extensive and longer procedures such as osteotomies or tendon reconstruction It also prolongs time away from work as well as home for rural patients who must relocate while awaiting surgery in major centers Previously it has been shown that performing closed hand fracture fixation on awake patients in a clinic or procedure room setting leads to 60-100 increases in daily case volume compared to the main operating room OR Gillis Steve Fixation of hand fractures in this setting has also been shown to cost over 2000 less than in the OR by reducing staffing requirements equipment and anesthesia costs Steve
Performing hand surgery in awake patients under local anesthesia has been shown by numerous studies to be a safe and effective Wide-awake hand surgery is generally well-tolerated has lower post-operative opioid requirements and is often preferred by patients Thompson Furthermore by preventing the need for general anesthesia this technique allows hand surgery to be performed in patients who may otherwise not be operative candidates During flexor tendon repair awake surgery provides the unique advantage of being able to actively test the repair intraoperatively In Canada awake surgery under local anesthesia is commonly done for tendon repairs carpal tunnel release and percutaneous pinning of fractures without a tourniquet Gillis Steve Peters While tourniquet use improves visualization of the operative field when only local anesthesia is used patients can typically tolerate the tourniquet for less than 20 minutes before pain begins
However for ORIFs flexor tendon repairs etc the use of a tourniquet is ideal for exposure of the operative site Current literature suggests that the maximum pain-free tourniquet time is roughly 20 minutes which is less than the average length of ORIFs Gillis and flexor tendon repair Intravenous regional anesthesia IVRA ie Bier blocks are well-established means of providing anesthesia for hand surgeries requiring tourniquet use and enable tourniquet times from 20 minutes to two hours Dekoninck Brown While these blocks prevent the need for general anesthesia they still require an anesthetist to perform and monitor the block More recently forearm tourniquets with IVRA have been shown to be non-inferior to traditional proximal arm tourniquets with lower doses of post-operative opioids required Dekoninck Farbood However compared to local anesthesia IVRA for procedures were tourniquets are preferred still increases costs staffing requirements and resource use as they often take place in the OR However local anesthetic infiltration by the treating surgeon may not provide sufficient pain relief for the amount of tourniquet time required to complete many hand surgeries Therefore although many methods of anesthesia for hand surgery exist include local anesthetic infiltration and proximal nerve blocks there is not yet one gold standard approach
Ultrasound guided peripheral nerve blocks at the forearm level have previously been shown to be a safe effective method of providing regional anesthesia for minor hand procedures that are tolerated well by patients Winter The technique can be quickly taught to even junior residents and does not require any specialized equipment outside of the ultrasound probe Winter These blocks take roughly five minutes to perform and anesthesia is achieved after an additional five minutes shorter than typical times for blind forearm nerve blocks Lovely
The investigators hypothesize that the pain patients experience after 20 minutes of tourniquet application with local anesthetic infiltration is not due to direct pressure on the proximal arm but rather distal digital ischemia pain Previously it has been shown that ultrasound-guided regional block of the median radial and ulnar nerves in the forearm is effective analgesia for awake hand surgery Winter Currently there are no randomized studies investigating if forearm nerve blocks can prolong pain-free tourniquet time compared to local anesthesia infiltration by blocking this ischemic pain in the distal arm The investigators aim is therefore to determine if forearm nerve blocks prolong pain-free tourniquet time compared to local anesthetic infiltration
All patients over 18 years of age booked for an awake hand surgery will be considered for inclusion These patients will be identified through emergency room consults referrals from outside centers and attending surgeon clinics at our institution Currently if patients require minor hand surgeries they are then assessed for suitability for having their procedure while awake using local anesthesia Patients who are candidates for awake surgery will then be informed of the research study by a resident physician assistant or attending physician and have the opportunity to consent to participation This will not be done by a residentphysician assistantattending physician who will be performing or assisting with the procedure Patients who consent to participation will then be randomized using a random number generator to receive either a forearm nerve block or local anesthetic infiltration The study will be open-label as both the patient and residentsurgeon will be aware of the type of block forearm vs local performed
The risks and benefits associated with forearm and local anesthesia blocks will be explained to the patient as part of the informed consent prior to randomization Patients will be recruited from attending physician clinics however the staff screening patients for eligibility and conducting informed consent will not be the individual who is either a performing the surgery or b collecting analyzing or interpreting the data Patients will have the remaining length of their clinic appointment to contemplate participation in the study
If patients in either group begin to experience pain during their procedure the tourniquet will be taken down and the time will be recorded Participants in both groups will receive adequate analgesia as additional local anesthetic will be administered if patients express pain during the procedure Total procedure time will also be recorded
The residentphysician performing the procedure will record the patients diagnosis type of procedure location duration of the entire procedure type and amount of local anesthetic used and duration of pain-free tourniquet time Any additional local anesthetic required during the procedure will be recorded Any deviations from the expected procedure or intraoperative complications will also be recorded The REB will be notified of any harms to patients as a result of the study occur Any subsequent recommendations from the REB regarding study termination will be followed If any patients experience local anesthetic toxicity sustain nerve or blood vessel damage or experience other intraoperative complications as a result the study interventions the study will be placed on hold until full review of the data is complete and terminated if appropriate Patients who were involved of the study to date will be contacted explaining the reason for termination of the study
After the procedure the resident involved in the procedure will provide the patient with the survey questions The individuals conducting the surveys will not otherwise be involved in the study This will be a two question survey recording the amount of pain felt during the procedure and overall experience with their awake hand surgery Both questions will be scored on a Numerical analogue scale NAS from 1-10 If the patient is unable to physical write due to splinting of the dominant hand the resident will record the answers verbalized by the patient
Data from the study will be reviewed on a weekly basis All complications will be noted Any major complication resulting in harm or near-harm to a patient will prompt review of the study data to date for any further complications including which group the participants experiencing the complication were assigned to
Performing hand surgery in awake patients under local anesthesia has been shown by numerous studies to be a safe and effective Wide-awake hand surgery is generally well-tolerated has lower post-operative opioid requirements and is often preferred by patients Thompson Furthermore by preventing the need for general anesthesia this technique allows hand surgery to be performed in patients who may otherwise not be operative candidates During flexor tendon repair awake surgery provides the unique advantage of being able to actively test the repair intraoperatively In Canada awake surgery under local anesthesia is commonly done for tendon repairs carpal tunnel release and percutaneous pinning of fractures without a tourniquet Gillis Steve Peters While tourniquet use improves visualization of the operative field when only local anesthesia is used patients can typically tolerate the tourniquet for less than 20 minutes before pain begins
However for ORIFs flexor tendon repairs etc the use of a tourniquet is ideal for exposure of the operative site Current literature suggests that the maximum pain-free tourniquet time is roughly 20 minutes which is less than the average length of ORIFs Gillis and flexor tendon repair Intravenous regional anesthesia IVRA ie Bier blocks are well-established means of providing anesthesia for hand surgeries requiring tourniquet use and enable tourniquet times from 20 minutes to two hours Dekoninck Brown While these blocks prevent the need for general anesthesia they still require an anesthetist to perform and monitor the block More recently forearm tourniquets with IVRA have been shown to be non-inferior to traditional proximal arm tourniquets with lower doses of post-operative opioids required Dekoninck Farbood However compared to local anesthesia IVRA for procedures were tourniquets are preferred still increases costs staffing requirements and resource use as they often take place in the OR However local anesthetic infiltration by the treating surgeon may not provide sufficient pain relief for the amount of tourniquet time required to complete many hand surgeries Therefore although many methods of anesthesia for hand surgery exist include local anesthetic infiltration and proximal nerve blocks there is not yet one gold standard approach
Ultrasound guided peripheral nerve blocks at the forearm level have previously been shown to be a safe effective method of providing regional anesthesia for minor hand procedures that are tolerated well by patients Winter The technique can be quickly taught to even junior residents and does not require any specialized equipment outside of the ultrasound probe Winter These blocks take roughly five minutes to perform and anesthesia is achieved after an additional five minutes shorter than typical times for blind forearm nerve blocks Lovely
The investigators hypothesize that the pain patients experience after 20 minutes of tourniquet application with local anesthetic infiltration is not due to direct pressure on the proximal arm but rather distal digital ischemia pain Previously it has been shown that ultrasound-guided regional block of the median radial and ulnar nerves in the forearm is effective analgesia for awake hand surgery Winter Currently there are no randomized studies investigating if forearm nerve blocks can prolong pain-free tourniquet time compared to local anesthesia infiltration by blocking this ischemic pain in the distal arm The investigators aim is therefore to determine if forearm nerve blocks prolong pain-free tourniquet time compared to local anesthetic infiltration
All patients over 18 years of age booked for an awake hand surgery will be considered for inclusion These patients will be identified through emergency room consults referrals from outside centers and attending surgeon clinics at our institution Currently if patients require minor hand surgeries they are then assessed for suitability for having their procedure while awake using local anesthesia Patients who are candidates for awake surgery will then be informed of the research study by a resident physician assistant or attending physician and have the opportunity to consent to participation This will not be done by a residentphysician assistantattending physician who will be performing or assisting with the procedure Patients who consent to participation will then be randomized using a random number generator to receive either a forearm nerve block or local anesthetic infiltration The study will be open-label as both the patient and residentsurgeon will be aware of the type of block forearm vs local performed
The risks and benefits associated with forearm and local anesthesia blocks will be explained to the patient as part of the informed consent prior to randomization Patients will be recruited from attending physician clinics however the staff screening patients for eligibility and conducting informed consent will not be the individual who is either a performing the surgery or b collecting analyzing or interpreting the data Patients will have the remaining length of their clinic appointment to contemplate participation in the study
If patients in either group begin to experience pain during their procedure the tourniquet will be taken down and the time will be recorded Participants in both groups will receive adequate analgesia as additional local anesthetic will be administered if patients express pain during the procedure Total procedure time will also be recorded
The residentphysician performing the procedure will record the patients diagnosis type of procedure location duration of the entire procedure type and amount of local anesthetic used and duration of pain-free tourniquet time Any additional local anesthetic required during the procedure will be recorded Any deviations from the expected procedure or intraoperative complications will also be recorded The REB will be notified of any harms to patients as a result of the study occur Any subsequent recommendations from the REB regarding study termination will be followed If any patients experience local anesthetic toxicity sustain nerve or blood vessel damage or experience other intraoperative complications as a result the study interventions the study will be placed on hold until full review of the data is complete and terminated if appropriate Patients who were involved of the study to date will be contacted explaining the reason for termination of the study
After the procedure the resident involved in the procedure will provide the patient with the survey questions The individuals conducting the surveys will not otherwise be involved in the study This will be a two question survey recording the amount of pain felt during the procedure and overall experience with their awake hand surgery Both questions will be scored on a Numerical analogue scale NAS from 1-10 If the patient is unable to physical write due to splinting of the dominant hand the resident will record the answers verbalized by the patient
Data from the study will be reviewed on a weekly basis All complications will be noted Any major complication resulting in harm or near-harm to a patient will prompt review of the study data to date for any further complications including which group the participants experiencing the complication were assigned to
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