Supplemental Evidence and Data Request on Peripheral Nerve Blocks for Postoperative Pain Management in Cardiothoracic Surgery, 46887-46889 [2024-11834]
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Federal Register / Vol. 89, No. 105 / Thursday, May 30, 2024 / Notices
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Supplemental Evidence and Data
Request on Peripheral Nerve Blocks
for Postoperative Pain Management in
Cardiothoracic Surgery
Agency for Healthcare Research
and Quality (AHRQ), HHS.
ACTION: Request for supplemental
evidence and data submission.
AGENCY:
The Agency for Healthcare
Research and Quality (AHRQ) is seeking
scientific information submissions from
the public. Scientific information is
being solicited to inform our review on
Peripheral Nerve Blocks for
Postoperative Pain Management in
Cardiothoracic Surgery, which is
currently being conducted by the
AHRQ’s Evidence-based Practice
Centers (EPC) Program. Access to
published and unpublished pertinent
SUMMARY:
PO 00000
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46887
scientific information will improve the
quality of this review.
DATES: Submission Deadline on or
before July 1, 2024.
ADDRESSES:
Email submissions: epc@
ahrq.hhs.gov.
Print submissions:
Mailing Address: Center for Evidence
and Practice Improvement, Agency for
Healthcare Research and Quality,
ATTN: EPC SEADs Coordinator, 5600
Fishers Lane, Mail Stop 06E53A,
Rockville, MD 20857.
Shipping Address (FedEx, UPS, etc.):
Center for Evidence and Practice
Improvement, Agency for Healthcare
Research and Quality, ATTN: EPC
SEADs Coordinator, 5600 Fishers Lane,
Mail Stop 06E77D, Rockville, MD
20857.
FOR FURTHER INFORMATION CONTACT:
Kelly Carper, Telephone: 301–427–1656
or Email: epc@ahrq.hhs.gov.
SUPPLEMENTARY INFORMATION: The
Agency for Healthcare Research and
Quality has commissioned the
Evidence-based Practice Centers (EPC)
Program to complete a review of the
evidence for Peripheral Nerve Blocks for
Postoperative Pain Management in
Cardiothoracic Surgery. AHRQ is
conducting this review pursuant to
Section 902 of the Public Health Service
Act, 42 U.S.C. 299a.
The EPC Program is dedicated to
identifying as many studies as possible
that are relevant to the questions for
each of its reviews. In order to do so, we
are supplementing the usual manual
and electronic database searches of the
literature by requesting information
from the public (e.g., details of studies
conducted). We are looking for studies
that report on Peripheral Nerve Blocks
for Postoperative Pain Management in
Cardiothoracic Surgery.
The entire research protocol is
available online at: https://
effectivehealthcare.ahrq.gov/products/
peripheral-nerve-blocks/protocol.
This is to notify the public that the
EPC Program would find the following
information on Peripheral Nerve Blocks
for Postoperative Pain Management in
Cardiothoracic Surgery helpful:
D A list of completed studies that
your organization has sponsored for this
topic. In the list, please indicate
whether results are available on
ClinicalTrials.gov along with the
ClinicalTrials.gov trial number.
D For completed studies that do not
have results on ClinicalTrials.gov, a
summary, including the following
elements, if relevant: study number,
study period, design, methodology,
E:\FR\FM\30MYN1.SGM
30MYN1
46888
Federal Register / Vol. 89, No. 105 / Thursday, May 30, 2024 / Notices
indication and diagnosis, proper use
instructions, inclusion and exclusion
criteria, primary and secondary
outcomes, baseline characteristics,
number of patients screened/eligible/
enrolled/lost to follow-up/withdrawn/
analyzed, effectiveness/efficacy, and
safety results.
D A list of ongoing studies that your
organization has sponsored for this
topic. In the list, please provide the
ClinicalTrials.gov trial number or, if the
trial is not registered, the protocol for
the study including, if relevant, a study
number, the study period, design,
methodology, indication and diagnosis,
proper use instructions, inclusion and
exclusion criteria, and primary and
secondary outcomes.
D Description of whether the above
studies constitute ALL Phase II and
above clinical trials sponsored by your
organization for this topic and an index
outlining the relevant information in
each submitted file.
Your contribution is very beneficial to
the Program. Materials submitted must
be publicly available or able to be made
public. Materials that are considered
confidential; marketing materials; study
types not included in the review; or
information on topics not included in
the review cannot be used by the EPC
Program. This is a voluntary request for
information, and all costs for complying
with this request must be borne by the
submitter.
The draft of this review will be posted
on AHRQ’s EPC Program website and
available for public comment for a
period of 4 weeks. If you would like to
be notified when the draft is posted,
please sign up for the email list at:
https://effectivehealthcare.ahrq.gov/
email-updates.
The review will answer the following
questions. This information is provided
as background. AHRQ is not requesting
that the public provide answers to these
questions.
Key Questions (KQ)
• KQ 1. In adult intrathoracic surgical
patients, what are the effectiveness,
comparative effectiveness, and
harms of peripheral nerve blocks for
managing postoperative pain and its
sequelae—including opioid use?
Æ KQ 1a. How do findings vary by
baseline patient clinical
characteristics (e.g., ASA status,
chronic opioids (>90 days), preexisting psychiatric diagnoses)?
PICOTS (POPULATIONS, INTERVENTIONS, COMPARATORS, OUTCOMES, TIMING, AND SETTING)
KQ1
Inclusion
Population ................
Intervention ...............
Comparators .............
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Outcomes .................
VerDate Sep<11>2014
Exclusion
Adult patients (18 years and older) undergoing the following open or minimally invasive (laparoscopic/
thoracoscopic), elective, or urgent intrathoracic surgeries *:
• Cardiac
• Lung
• Other intrathoracic
KQ 1a Subgroups: Patients taking opioid medications for
chronic pain, those with preexisting psychiatric diagnoses, and ASA status.
Peripheral nerve block (PNB) either alone or as part of
multimodal analgesia for postoperative pain management.
Placebo, sham, usual care, multimodal analgesia without
peripheral nerve block, other peripheral nerve block administration (e.g., differing location, continuous vs. single
shot), local anesthesia infiltration at surgical incision,
neuraxial blockade (epidural, spinal, caudal, and
paravertebral nerve blocks).
Early//intermediate (72 hours or time of discharge to ≤3
months postoperative):
• Pain intensity
• Opioid use
• Pain trajectory
• Pain interference
• Quality of recovery
• Health-related quality of life (HRQoL)
• Patient satisfaction
• Hospital length of stay
• Cost to patient
Long-term (>3 months postoperative):
• Physical functional status
• Opioid use
• Chronic postsurgical pain
• Intensity of chronic postsurgical pain
• HRQoL
• Patient satisfaction
Harms:
• Complications/adverse events of treatment (nerve
damage, bleeding, all-cause return to ED/hospital
within 30 days, etc.)
• Rebound pain—increased pain relative to controls
when the block subsides.
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—Pediatric patients under the age of 18 years.
—Patients undergoing spine, head/neck, orthopedic,
breast, abdominal, pelvic, peritoneal, retroperitoneal, or
obstetric surgery.
—Pregnant patients.
—Other surgery not listed.
—Emergency surgery.
—Other pain management strategies not considered peripheral nerve blocks.
—Cryoanesthesia/cryoanalgesia.
—PNBs used for limb or excluded surgery.
—Neuraxial blockade (epidural, spinal, caudal, and
paravertebral nerve blocks).
Same peripheral nerve block but with different dose/additives or different local anesthetic (bupivacaine vs.
ropivacaine or vs. liposomal/long-acting local anesthetic).
Outcomes not listed.
Studies excluded if postoperative pain intensity is not reported.
E:\FR\FM\30MYN1.SGM
30MYN1
Federal Register / Vol. 89, No. 105 / Thursday, May 30, 2024 / Notices
46889
PICOTS (POPULATIONS, INTERVENTIONS, COMPARATORS, OUTCOMES, TIMING, AND SETTING)—Continued
KQ1
Inclusion
Outcome Timing .......
Post-operative period ≤3 months subdivided into 72 hours
or less; >72 hours or discharge up to <30 days; 30 days
up to ≤3 months.
Post-operative period 3–12 months.
Perioperative (inpatient or outpatient) setting for intervention.
Perioperative and all follow-up settingsfor outcomes.
Randomized controlled trials (RCTs).
Minimum sample size per arm of ≥30 participants. If a particular intervention/comparator is not represented in the
studies of 30/arm or greater, we will include studies of
smaller size for that unique intervention/comparator.
English-only peer-reviewed publications from 2013. (Consistent with other current ASA systematic reviews on regional anesthesia.)
Setting ......................
Study design ............
Publications ..............
Exclusion
Other timing.
Nerve blocks performed in the outpatient clinic.
Nerve blocks performed outside of the preoperative day-ofsurgery to the 24-hours postoperative.
Non-randomized, observational, non-controlled study designs, cross-sectional, prevalence, qualitative, case reports, opinions/letters, pilot studies, feasibility studies.
Studies with a sample size <30 participants analyzed in
any arm.
Comments, editorials, and letters.
* EMERGENCY—A surgical, therapeutic, or diagnostic procedure that cannot be delayed without causing a significant risk of death or permanent impairment. Note: The American Society of Anesthesiologists (ASA) Physical Status should include ‘‘E’’. The designation of a procedure as
an emergency is determined by a surgeon and/or an anesthesiologist.
URGENT—A surgical, therapeutic, or diagnostic procedure that must be performed to prevent death or permanent impairment but that can be
delayed. Note: The procedure may be delayed to allow for medical optimization of the patient or to permit better availability of resources (e.g.,
personnel or equipment).
ELECTIVE—A surgical, therapeutic, or diagnostic procedure that can be performed at any time or date with an agreement between the surgeon and the patient.
Dated: May 22, 2024.
Marquita Cullom,
Associate Director.
membership on the ACD, CDC must be
received no later than July 8, 2024. Late
nominations will not be considered for
membership.
[FR Doc. 2024–11834 Filed 5–29–24; 8:45 am]
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vitae/resumes) should be emailed to
ACDirector@cdc.gov with the subject
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Centers for Disease Control and
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Centers for Disease Control and
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Human Services (HHS).
ACTION: Notice.
AGENCY:
In accordance with the
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Centers for Disease Control and
Prevention (CDC), within the
Department of Health and Human
Services (HHS), is seeking nominations
for membership on the Advisory
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nominations for membership on the
ACD, CDC published May 8, 2024, at 89
FR 38900, is extended. Nominations for
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Kalwant Smagh,
Director, Office of Strategic Business
Initiatives, Office of the Chief Operating
Officer, Centers for Disease Control and
Prevention.
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Appointment to the Advisory
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Notice of Extension
SUMMARY:
Prevention and the Agency for Toxic
Substances and Disease Registry.
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the Chief of Staff, Centers for Disease
Control and Prevention, 1600 Clifton
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498–6655; Email: ACDirector@cdc.gov.
SUPPLEMENTARY INFORMATION:
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deadline for nominations for
appointment to the Advisory Committee
to the Director, Centers for Disease
Control and Prevention has been
extended from June 7, 2024, to July 8,
2024. The original solicitation of
nominations notice was published in
the Federal Register on May 8, 2024,
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The Director, Office of Strategic
Business Initiatives, Office of the Chief
Operating Officer, Centers for Disease
Control and Prevention, has been
delegated the authority to sign Federal
Register notices pertaining to
announcements of meetings and other
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for Office of Management
and Budget Review; Family Violence
Prevention and Services Grants to
States; Native American Tribes and
Alaskan Native Villages; and State
Domestic Violence Coalitions (Office of
Management and Budget #0970–0280)
Office of Family Violence
Prevention and Services;
Administration for Children and
Families; Department of Health and
Human Services.
ACTION: Request for public comments.
AGENCY:
The Family Violence
Prevention and Services Act (FVPSA)
program within the Office of Family
Violence Prevention and Services
(OFVPS) plans revised program
announcements and minor changes to
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(Office of Management and Budget
(OMB) #0970–0280; Expiration Date:
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SUMMARY:
E:\FR\FM\30MYN1.SGM
30MYN1
]]>Agencies
[Federal Register Volume 89, Number 105 (Thursday, May 30, 2024)]
[Notices]
[Pages 46887-46889]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-11834]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Supplemental Evidence and Data Request on Peripheral Nerve Blocks
for Postoperative Pain Management in Cardiothoracic Surgery
AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.
ACTION: Request for supplemental evidence and data submission.
-----------------------------------------------------------------------
SUMMARY: The Agency for Healthcare Research and Quality (AHRQ) is
seeking scientific information submissions from the public. Scientific
information is being solicited to inform our review on Peripheral Nerve
Blocks for Postoperative Pain Management in Cardiothoracic Surgery,
which is currently being conducted by the AHRQ's Evidence-based
Practice Centers (EPC) Program. Access to published and unpublished
pertinent scientific information will improve the quality of this
review.
DATES: Submission Deadline on or before July 1, 2024.
ADDRESSES:
Email submissions: [email protected].
Print submissions:
Mailing Address: Center for Evidence and Practice Improvement,
Agency for Healthcare Research and Quality, ATTN: EPC SEADs
Coordinator, 5600 Fishers Lane, Mail Stop 06E53A, Rockville, MD 20857.
Shipping Address (FedEx, UPS, etc.): Center for Evidence and
Practice Improvement, Agency for Healthcare Research and Quality, ATTN:
EPC SEADs Coordinator, 5600 Fishers Lane, Mail Stop 06E77D, Rockville,
MD 20857.
FOR FURTHER INFORMATION CONTACT: Kelly Carper, Telephone: 301-427-1656
or Email: [email protected].
SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and
Quality has commissioned the Evidence-based Practice Centers (EPC)
Program to complete a review of the evidence for Peripheral Nerve
Blocks for Postoperative Pain Management in Cardiothoracic Surgery.
AHRQ is conducting this review pursuant to Section 902 of the Public
Health Service Act, 42 U.S.C. 299a.
The EPC Program is dedicated to identifying as many studies as
possible that are relevant to the questions for each of its reviews. In
order to do so, we are supplementing the usual manual and electronic
database searches of the literature by requesting information from the
public (e.g., details of studies conducted). We are looking for studies
that report on Peripheral Nerve Blocks for Postoperative Pain
Management in Cardiothoracic Surgery.
The entire research protocol is available online at: https://effectivehealthcare.ahrq.gov/products/peripheral-nerve-blocks/protocol.
This is to notify the public that the EPC Program would find the
following information on Peripheral Nerve Blocks for Postoperative Pain
Management in Cardiothoracic Surgery helpful:
[ssquf] A list of completed studies that your organization has
sponsored for this topic. In the list, please indicate whether results
are available on ClinicalTrials.gov along with the ClinicalTrials.gov
trial number.
[ssquf] For completed studies that do not have results on
ClinicalTrials.gov, a summary, including the following elements, if
relevant: study number, study period, design, methodology,
[[Page 46888]]
indication and diagnosis, proper use instructions, inclusion and
exclusion criteria, primary and secondary outcomes, baseline
characteristics, number of patients screened/eligible/enrolled/lost to
follow-up/withdrawn/analyzed, effectiveness/efficacy, and safety
results.
[ssquf] A list of ongoing studies that your organization has
sponsored for this topic. In the list, please provide the
ClinicalTrials.gov trial number or, if the trial is not registered, the
protocol for the study including, if relevant, a study number, the
study period, design, methodology, indication and diagnosis, proper use
instructions, inclusion and exclusion criteria, and primary and
secondary outcomes.
[ssquf] Description of whether the above studies constitute ALL
Phase II and above clinical trials sponsored by your organization for
this topic and an index outlining the relevant information in each
submitted file.
Your contribution is very beneficial to the Program. Materials
submitted must be publicly available or able to be made public.
Materials that are considered confidential; marketing materials; study
types not included in the review; or information on topics not included
in the review cannot be used by the EPC Program. This is a voluntary
request for information, and all costs for complying with this request
must be borne by the submitter.
The draft of this review will be posted on AHRQ's EPC Program
website and available for public comment for a period of 4 weeks. If
you would like to be notified when the draft is posted, please sign up
for the email list at: https://effectivehealthcare.ahrq.gov/email-updates.
The review will answer the following questions. This information is
provided as background. AHRQ is not requesting that the public provide
answers to these questions.
Key Questions (KQ)
KQ 1. In adult intrathoracic surgical patients, what are the
effectiveness, comparative effectiveness, and harms of peripheral nerve
blocks for managing postoperative pain and its sequelae--including
opioid use?
[cir] KQ 1a. How do findings vary by baseline patient clinical
characteristics (e.g., ASA status, chronic opioids (>90 days), pre-
existing psychiatric diagnoses)?
PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, and Setting)
--------------------------------------------------------------------------------------------------------------------------------------------------------
KQ1 Inclusion Exclusion
--------------------------------------------------------------------------------------------------------------------------------------------------------
Population......................... Adult patients (18 years and older) undergoing the --Pediatric patients under the age of 18 years.
following open or minimally invasive (laparoscopic/ --Patients undergoing spine, head/neck, orthopedic,
thoracoscopic), elective, or urgent intrathoracic breast, abdominal, pelvic, peritoneal, retroperitoneal,
surgeries *: or obstetric surgery.
Cardiac --Pregnant patients.
Lung --Other surgery not listed.
Other intrathoracic --Emergency surgery.
KQ 1a Subgroups: Patients taking opioid medications for
chronic pain, those with preexisting psychiatric
diagnoses, and ASA status.
Intervention....................... Peripheral nerve block (PNB) either alone or as part of --Other pain management strategies not considered
multimodal analgesia for postoperative pain management. peripheral nerve blocks.
--Cryoanesthesia/cryoanalgesia.
--PNBs used for limb or excluded surgery.
--Neuraxial blockade (epidural, spinal, caudal, and
paravertebral nerve blocks).
Comparators........................ Placebo, sham, usual care, multimodal analgesia without Same peripheral nerve block but with different dose/
peripheral nerve block, other peripheral nerve block additives or different local anesthetic (bupivacaine
administration (e.g., differing location, continuous vs. vs. ropivacaine or vs. liposomal/long-acting local
single shot), local anesthesia infiltration at surgical anesthetic).
incision, neuraxial blockade (epidural, spinal, caudal,
and paravertebral nerve blocks).
Outcomes........................... Early//intermediate (72 hours or time of discharge to <=3 Outcomes not listed.
months postoperative): Studies excluded if postoperative pain intensity is not
Pain intensity reported.
Opioid use
Pain trajectory
Pain interference
Quality of recovery
Health-related quality of life (HRQoL)
Patient satisfaction
Hospital length of stay
Cost to patient
Long-term (3 months postoperative):
Physical functional status
Opioid use
Chronic postsurgical pain
Intensity of chronic postsurgical pain
HRQoL
Patient satisfaction
Harms:
Complications/adverse events of treatment
(nerve damage, bleeding, all-cause return to ED/
hospital within 30 days, etc.)
Rebound pain--increased pain relative to
controls when the block subsides.
[[Page 46889]]
Outcome Timing..................... Post-operative period <=3 months subdivided into 72 hours Other timing.
or less; >72 hours or discharge up to <30 days; 30 days
up to <=3 months.
Post-operative period 3-12 months.
Setting............................ Perioperative (inpatient or outpatient) setting for Nerve blocks performed in the outpatient clinic.
intervention. Nerve blocks performed outside of the preoperative day-
Perioperative and all follow-up settingsfor outcomes. of-surgery to the 24-hours postoperative.
Study design....................... Randomized controlled trials (RCTs). Non-randomized, observational, non-controlled study
Minimum sample size per arm of >=30 participants. If a designs, cross-sectional, prevalence, qualitative, case
particular intervention/comparator is not represented in reports, opinions/letters, pilot studies, feasibility
the studies of 30/arm or greater, we will include studies.
studies of smaller size for that unique intervention/ Studies with a sample size <30 participants analyzed in
comparator. any arm.
Publications....................... English-only peer-reviewed publications from 2013. Comments, editorials, and letters.
(Consistent with other current ASA systematic reviews on
regional anesthesia.)
--------------------------------------------------------------------------------------------------------------------------------------------------------
* EMERGENCY--A surgical, therapeutic, or diagnostic procedure that cannot be delayed without causing a significant risk of death or permanent
impairment. Note: The American Society of Anesthesiologists (ASA) Physical Status should include ``E''. The designation of a procedure as an emergency
is determined by a surgeon and/or an anesthesiologist.
URGENT--A surgical, therapeutic, or diagnostic procedure that must be performed to prevent death or permanent impairment but that can be delayed. Note:
The procedure may be delayed to allow for medical optimization of the patient or to permit better availability of resources (e.g., personnel or
equipment).
ELECTIVE--A surgical, therapeutic, or diagnostic procedure that can be performed at any time or date with an agreement between the surgeon and the
patient.
Dated: May 22, 2024.
Marquita Cullom,
Associate Director.
[FR Doc. 2024-11834 Filed 5-29-24; 8:45 am]
BILLING CODE 4160-90-P
