Ignite Creation Date:
2024-05-06 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 12:51 PM
Study NCT ID:
NCT03632304
Status:
COMPLETED
Last Update Posted:
2021-04-21
First Post:
2018-08-08
Brief Title:
Local Anesthesia With Minimal Sedation and Brachial Plexus Block in Hand Surgery
Sponsor:
McGill University Health CentreResearch Institute of the McGill University Health Centre
Organization:
McGill University Health CentreResearch Institute of the McGill University Health Centre
Study Overview
Official Title:
The Quality of Recovery of Local Anesthesia With Minimal Sedation and Brachial Plexus Block in Hand Surgery A Randomized Controlled Study
Status:
COMPLETED
Status Verified Date:
2021-04
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:
A major innovation in hand surgery in the last decade is the popularization of Wide Awake Hand Surgery WAHS This technique consists of numbing the surgical area with local anesthesia with epinephrine and allowing the patient to actively move their hand intra-operatively to assess the strength and quality of repairs or fixations Despite its theoretical advantages the application in clinical practice has seldom spread further than simple hand operations such as carpal tunnel and trigger finger releases In many institutions the current standard of care for hand surgery is the brachial plexus block The primary objective of the study to directly compare the effects of local anesthesia with minimal sedation performed by the surgeon and the brachial plexus block performed by the anesthesiologist on patient-reported quality of recovery
Currently there are no studies in the surgical literature directly comparing patient-reported quality of recovery post-operative pain control or time efficiency between local anesthesia and the brachial plexus block in hand surgery This lack of information is a major impediment to the acceptance and adoption of a simple yet effective anesthesia technique that may increase patient satisfaction and time efficiency in the operating room This proposed prospective randomized controlled study will quantitatively compare local anesthesia and brachial plexus block on three fronts 1 patient-reported recovery at 24-hours post-surgery using the validated Quality of Recovery 15 score QoR-15 2 post-operative pain and opioid use at 24-hours post-surgery and 3 nonsurgical time defined as the time elapsed from one surgerys end time to the next surgerys start time as a metric for turnover efficiency The investigators hypothesize that patients randomized to the local anesthesia group will have a more positive recovery experience a similar pain profile compared to the brachial plexus block despite common beliefs and a shorter anesthesia-related and nonsurgical time
The importance of patient-centered care cannot be understated in a successful and high-quality health care system The results of this study will provide valuable information regarding the patient experience during their post- operative recovery
Currently there are no studies in the surgical literature directly comparing patient-reported quality of recovery post-operative pain control or time efficiency between local anesthesia and the brachial plexus block in hand surgery This lack of information is a major impediment to the acceptance and adoption of a simple yet effective anesthesia technique that may increase patient satisfaction and time efficiency in the operating room This proposed prospective randomized controlled study will quantitatively compare local anesthesia and brachial plexus block on three fronts 1 patient-reported recovery at 24-hours post-surgery using the validated Quality of Recovery 15 score QoR-15 2 post-operative pain and opioid use at 24-hours post-surgery and 3 nonsurgical time defined as the time elapsed from one surgerys end time to the next surgerys start time as a metric for turnover efficiency The investigators hypothesize that patients randomized to the local anesthesia group will have a more positive recovery experience a similar pain profile compared to the brachial plexus block despite common beliefs and a shorter anesthesia-related and nonsurgical time
The importance of patient-centered care cannot be understated in a successful and high-quality health care system The results of this study will provide valuable information regarding the patient experience during their post- operative recovery
Detailed Description:
In many hospitals the widely-accepted benefits of local anesthesia have moved minor hand operations such as carpal tunnel and trigger finger release outside of the main operating room The proven benefits of local anesthesia include increased efficiency convenience and patient comfort reduced costs lack of pre-operative tests and decreased operative time Multiple complex hand operations have been described using lidocaine and epinephrine only with the patient wide awake during surgery These include K-wire fixation flexor tendon repair tendon transfers and tendon grafting For those unfamiliar with this technique the main concerns are that it is poorly tolerated does not prevent patient movement and inadequately controls post-operative pain which all negatively influence a surgeons comfort and adoption of this technique Thus despite its many advantages local anesthesia in complex hand surgery is still not widely practiced in North America
Alternatively the brachial plexus block is a common method of regional anesthesia used in hand surgery consisting of anesthetizing the entire upper limb via local anesthesia infiltration of the brachial plexus This reliable sensorimotor blockade is performed under ultrasound guidance by an anesthesiologist approximately 30 minutes prior to surgery Although safe and effective to use its long duration of action increased need for operating room resources and unpleasant sensation of a flaccid and insensate upper extremity has prompted research into alternative ultrasound-guided nerve blocks in hand surgery
Despite prior published data on the use of local anesthesia with epinephrine and brachial plexus blocks in hand surgery there is a paucity of randomized-controlled prospective patient-reported outcome studies comparing these two methods of anesthesia This study aims to capture patient-reported quality of recovery using a validated psychometrically tested questionnaire the Quality-of-Recovery 15 A recent systematic review of the measurement properties of QoR-15 showed good content validity and internal consistency and concluded that it fulfills requirements for outcome measurement instruments in clinical trials
Preliminary data was obtained from a pilot study of 11 hand surgery patients who underwent a brachial plexus block and were called 24 hours after surgery to answer the QoR-15 questionnaire The computed mean QoR score was 118150 - 15 consistent with values reported in the literature This pilot study allowed for the calculation of a projected sample size for this study outlined below
This is a prospective single institution randomized controlled study taking place at the Montreal General Hospital in Montreal Canada The institution is a level I trauma center which performs a minimum of 250 upper extremity surgeries yearly The study participants are trauma or elective hand surgery patients above 18 years undergoing surgery less than 2 hours in duration distal to the carpal bones
Patients who consent to the study will be randomized to receive local anesthesia with minimal sedation intervention group or a brachial plexus block control group using wwwrandomorg a random number generating website The local anesthesia in the intervention group will be administered by the operating hand surgeon or a senior resident under the surgeons direct supervision as a wrist block andor digital block The regional blocks in the control group will be performed as an infraclavicular brachial plexus block by a staff anesthesiologist with extensive experience in ultrasound-guided regional anesthesia
This study is designed as a prospective non-inferiority study using an alpha of 005 for statistical significance and a power of 80 Using QoR-15 values derived from the pilot study with effect size of 054 a power analysis was conducted yielding a sample size of 44 patients per group for a total of 88 patients All quantitative outcome parameters will be evaluated for normal distribution and reported as mean - SD or median IQR Differences between two groups will be evaluated using unpaired Students T-Test if parametric or Mann-Whitney-U test if non-parametric
The patients will be called on the first post-operative day at least 24 hours after the end of their surgery by a research assistant blinded to the randomization As a primary outcome measure the patient will be asked to answer the questions on the QoR-15 without revealing their surgery or method of anesthesia The dosage of the medications used and the number of times an opioid medication was taken will be recorded The nonsurgical time for the local anesthesia and brachial plexus groups will also be directly compared Nonsurgical time is defined as the time elapsed between the completion of surgical closure on one case until the surgical incision on the next case
The study will be conducted in accord with the Tri-Council Policy Statement Ethical Conduct for Research Involving Humans 2014 as well as in respect of the requirements set out by the McGill University Health Centre Research Ethics Board
Alternatively the brachial plexus block is a common method of regional anesthesia used in hand surgery consisting of anesthetizing the entire upper limb via local anesthesia infiltration of the brachial plexus This reliable sensorimotor blockade is performed under ultrasound guidance by an anesthesiologist approximately 30 minutes prior to surgery Although safe and effective to use its long duration of action increased need for operating room resources and unpleasant sensation of a flaccid and insensate upper extremity has prompted research into alternative ultrasound-guided nerve blocks in hand surgery
Despite prior published data on the use of local anesthesia with epinephrine and brachial plexus blocks in hand surgery there is a paucity of randomized-controlled prospective patient-reported outcome studies comparing these two methods of anesthesia This study aims to capture patient-reported quality of recovery using a validated psychometrically tested questionnaire the Quality-of-Recovery 15 A recent systematic review of the measurement properties of QoR-15 showed good content validity and internal consistency and concluded that it fulfills requirements for outcome measurement instruments in clinical trials
Preliminary data was obtained from a pilot study of 11 hand surgery patients who underwent a brachial plexus block and were called 24 hours after surgery to answer the QoR-15 questionnaire The computed mean QoR score was 118150 - 15 consistent with values reported in the literature This pilot study allowed for the calculation of a projected sample size for this study outlined below
This is a prospective single institution randomized controlled study taking place at the Montreal General Hospital in Montreal Canada The institution is a level I trauma center which performs a minimum of 250 upper extremity surgeries yearly The study participants are trauma or elective hand surgery patients above 18 years undergoing surgery less than 2 hours in duration distal to the carpal bones
Patients who consent to the study will be randomized to receive local anesthesia with minimal sedation intervention group or a brachial plexus block control group using wwwrandomorg a random number generating website The local anesthesia in the intervention group will be administered by the operating hand surgeon or a senior resident under the surgeons direct supervision as a wrist block andor digital block The regional blocks in the control group will be performed as an infraclavicular brachial plexus block by a staff anesthesiologist with extensive experience in ultrasound-guided regional anesthesia
This study is designed as a prospective non-inferiority study using an alpha of 005 for statistical significance and a power of 80 Using QoR-15 values derived from the pilot study with effect size of 054 a power analysis was conducted yielding a sample size of 44 patients per group for a total of 88 patients All quantitative outcome parameters will be evaluated for normal distribution and reported as mean - SD or median IQR Differences between two groups will be evaluated using unpaired Students T-Test if parametric or Mann-Whitney-U test if non-parametric
The patients will be called on the first post-operative day at least 24 hours after the end of their surgery by a research assistant blinded to the randomization As a primary outcome measure the patient will be asked to answer the questions on the QoR-15 without revealing their surgery or method of anesthesia The dosage of the medications used and the number of times an opioid medication was taken will be recorded The nonsurgical time for the local anesthesia and brachial plexus groups will also be directly compared Nonsurgical time is defined as the time elapsed between the completion of surgical closure on one case until the surgical incision on the next case
The study will be conducted in accord with the Tri-Council Policy Statement Ethical Conduct for Research Involving Humans 2014 as well as in respect of the requirements set out by the McGill University Health Centre Research Ethics Board
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