Notice2024-11834
Supplemental Evidence and Data Request on Peripheral Nerve Blocks for Postoperative Pain Management in Cardiothoracic Surgery
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
May 30, 2024
Issuing agencies
Health and Human Services DepartmentAgency for Healthcare Research and Quality
Abstract
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 Access to published and unpublished pertinent scientific information will improve the quality of this review.
Full Text
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<title>Federal Register, Volume 89 Issue 105 (Thursday, May 30, 2024)</title>
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[Federal Register Volume 89, Number 105 (Thursday, May 30, 2024)]
[Notices]
[Pages 46887-46889]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-11834]
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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: Agency for Healthcare Research and Quality (AHRQ), HHS.
ACTION: Request for supplemental evidence and data submission.
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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 Access to published and unpublished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: <a href="/cdn-cgi/l/email-protection#0663766546676e7477286e6e7528616970"><span class="__cf_email__" data-cfemail="0663766546676e7477286e6e7528616970">[email protected]</span></a>.
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: <a href="/cdn-cgi/l/email-protection#0164716241606973702f6969722f666e77"><span class="__cf_email__" data-cfemail="b5d0c5d6f5d4ddc7c49bddddc69bd2dac3">[email protected]</span></a>.
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: <a href="https://effectivehealthcare.ahrq.gov/products/peripheral-nerve-blocks/protocol">https://effectivehealthcare.ahrq.gov/products/peripheral-nerve-blocks/protocol</a>.
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 <a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a> along with the <a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a>
trial number.
[ssquf] For completed studies that do not have results on
<a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a>, a summary, including the following elements, if
relevant: study number, study period, design, methodology,
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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
<a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a> 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: <a href="https://effectivehealthcare.ahrq.gov/email-updates">https://effectivehealthcare.ahrq.gov/email-updates</a>.
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)
<bullet> 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)
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KQ1 Inclusion Exclusion
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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.
<bullet> Cardiac --Pregnant patients.
<bullet> Lung --Other surgery not listed.
<bullet> 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
<bullet> Pain intensity reported.
<bullet> Opioid use
<bullet> Pain trajectory
<bullet> Pain interference
<bullet> Quality of recovery
<bullet> Health-related quality of life (HRQoL)
<bullet> Patient satisfaction
<bullet> Hospital length of stay
<bullet> Cost to patient
Long-term (<ls-thn-eq>3 months postoperative):
<bullet> Physical functional status
<bullet> Opioid use
<bullet> Chronic postsurgical pain
<bullet> Intensity of chronic postsurgical pain
<bullet> HRQoL
<bullet> Patient satisfaction
Harms:
<bullet> Complications/adverse events of treatment
(nerve damage, bleeding, all-cause return to ED/
hospital within 30 days, etc.)
<bullet> Rebound pain--increased pain relative to
controls when the block subsides.
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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.)
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* 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
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