2024-11834. 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 Access to published and unpublished pertinent scientific information will improve the quality of this review.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: [e-mail].

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: [phone] or Email: [e-mail].

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:

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.

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, 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.

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.

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?

○ 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 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.	—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.
Intervention	Peripheral nerve block (PNB) either alone or as part of multimodal analgesia for postoperative pain management.	—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).
Comparators	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).	Same peripheral nerve block but with different dose/additives or different local anesthetic (bupivacaine vs. ropivacaine or vs. liposomal/long-acting local anesthetic).
Outcomes	Early//intermediate (72 hours or time of discharge to ≤3 months postoperative):  • Pain intensity	Outcomes not listed. Studies excluded if postoperative pain intensity is not 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.
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.	Other timing.
Setting	Perioperative (inpatient or outpatient) setting for intervention. Perioperative and all follow-up settingsfor outcomes.	Nerve blocks performed in the outpatient clinic. Nerve blocks performed outside of the preoperative day-of-surgery to the 24-hours postoperative.
Study design	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.	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.
Publications	English-only peer-reviewed publications from 2013. (Consistent with other current ASA systematic reviews on regional anesthesia.)	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.