[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 Access to published and unpublished 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