# 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 Access to published and unpublished pertinent scientific information will improve the quality of this review.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:
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)?
| KQ1 | Inclusion | Exclusion |
| --- | --- | --- |
| Population | Adult patients (18 years and older) undergoing the following open or minimally invasive (laparoscopic/thoracoscopic), elective, or urgent intrathoracic surgeries *: | —Pediatric patients under the age of 18 years. |
| 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. |
| Comparators | Placebo, sham, usual care, multimodal analgesia without peripheral nerve block, other peripheral nerve block administration (
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 | | Outcomes not listed. |
| | • Opioid use | |
| | • Pain trajectory | |
| | • Pain interference | |
| | • Quality of recovery | |
| | • Health-related quality of life (HRQoL) | |
| | • Patient satisfaction | |
| | • Hospital length of stay | |
| | • Cost to patient | |
| | | |
| | • Physical functional status | |
| | • Opioid use | |
| | • Chronic postsurgical pain | |
| | • Intensity of chronic postsurgical pain | |
| | • HRQoL | |
| | • Patient satisfaction | |
| | | |
| | • 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. | Other timing. |
| Setting | Perioperative (inpatient or outpatient) setting for intervention. | Nerve blocks performed in the outpatient clinic. |
| Study design | Randomized controlled trials (RCTs). | Non-randomized, observational, non-controlled study designs, cross-sectional, prevalence, qualitative, case reports, opinions/letters, pilot studies, feasibility studies. |
| Publications | English-only peer-reviewed publications from 2013. (Consistent with other current ASA systematic reviews on regional anesthesia.) | Comments, editorials, and letters. |
Dated: May 22, 2024.
Marquita Cullom,
Associate Director.