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This randomized, double-blinded, placebo-controlled trial seeks to evaluate the analgesic efficacy of the pericapsular nerve group block in the setting of outpatient hip arthroscopy.
The pericapsular nerve group, or PENG block, has been recently described and shows promise in providing analgesia to the hip joint. The analgesic value of this block in the setting of hip arthroscopy is unknown. This study aims to compare a preoperative PENG block to placebo block prior to outpatient hip arthroscopy under general anesthesia. The primary outcome measure is immediate postoperative pain as measured by numerical rating score in the post-anesthesia care unit (PACU). Secondary outcomes include opioid consumption, opioid-related adverse events, patient satisfaction, chronic opioid usage, and pain scores at other time points.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preop PENG Block | Experimental | Patients will receive a preoperative ultrasound-guided pericapsular nerve group block with 20 mL 0.5% ropivacaine in a manner consistent with Girón-Arango et al 2018 (PMID:30063657). Using appropriate sterile precautions, and procedural sedation with up to 2 mg IV midazolam, an ultrasound (SonoSite S-Nerve or Export) equipped with either a linear 15-6 megahertz (MHz), or a curvilinear 5-2 MHz transducer (habitus-dependent) is used to identify the anterior inferior iliac spine, iliopubic eminence, and psoas muscle. After skin localization with 1-2 mL 1% lidocaine, a 22g 80 mm echogenic block needle (Pajunk SonoBlock II Facet) is advanced lateral to medial, in plane with the ultrasound beam, beneath the psoas tendon to the iliopubic eminence. 20 mL 0.5% ropivacaine is injected beneath the psoas tendon and above the iliopubic eminence, in 5 mL increments with periodic aspiration to prevent intravascular injection. The needle is withdrawn, and the needle entry site wiped clean. |
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| Placebo | Placebo Comparator | Patients in the placebo group will receive a subcutaneous injection of 5 mL 0.9% normal saline. Using appropriate sterile precautions, and procedural sedation with up to 2 mg IV midazolam, an ultrasound (SonoSite S-Nerve or Export) equipped with either a linear 15-6 megahertz (MHz), or a curvilinear 5-2 MHz transducer (habitus-dependent) is used to identify the anterior inferior iliac spine, iliopubic eminence, and psoas muscle. After skin localization with 1-2 mL 1% lidocaine, a 22g 80 mm echogenic block needle (Pajunk SonoBlock II Facet) is advanced lateral to medial, in plane with the ultrasound beam, 1-2 cm beneath the skin, remaining in the subcutaneous tissue. 5 mL of 0.9% normal saline is injected, with periodic aspiration to prevent intravascular injection. The needle is withdrawn, and the needle entry site wiped clean. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preop PENG block | Procedure | Ultrasound-guided injection of 20 mL 0.5% ropivacaine according to the method described by Giron-Arango L in 2018. A needle is inserted at the inguinal level under ultrasound guidance to pass beneath the psoas tendon on top of the iliopubic eminence where the local anesthetic is injected. |
| Measure | Description | Time Frame |
|---|---|---|
| PACU pain score | Maximum pain score within the first 30 minutes after emergence in the post-anesthesia care unit. Pain will be assessed by numerical rating score (0-10, where 0 is no pain, and 10 is the worst possible pain). | Within 30 minutes of emergence from anesthesia. |
| Measure | Description | Time Frame |
|---|---|---|
| PACU opioid consumption | Total morphine milligram equivalents required by patients in the post-anesthesia care unit, prior to discharge from the outpatient surgery center. Following emergence from anesthesia, pain will be assessed in regular intervals, with administration of IV and oral opioids according to numeric rating scale and clinical assessment. Opioid administration stops when patient numerical rating score is <4, when patient endorses manageable pain level, when side effects of opioids are intolerable, or for other concerning clinical conditions as determined by the anesthesiologist of record. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter E Amato, MD | University of Virginia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UVA Outpatient Surgery Center | Charlottesville | Virginia | 22903 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30063657 | Background | Giron-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular Nerve Group (PENG) Block for Hip Fracture. Reg Anesth Pain Med. 2018 Nov;43(8):859-863. doi: 10.1097/AAP.0000000000000847. | |
| 35998937 | Derived | Amato PE, Coleman JR, Dobrzanski TP, Elmer DA, Gwathmey FW Jr, Slee AE, Hanson NA. Pericapsular nerve group (PENG) block for hip arthroscopy: a randomized, double-blinded, placebo-controlled trial. Reg Anesth Pain Med. 2022 Aug 23:rapm-2022-103907. doi: 10.1136/rapm-2022-103907. Online ahead of print. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Aug 19, 2020 | Mar 9, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D010146 | Pain |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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Randomized, double blind, placebo controlled
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Subjects will be randomized to one of two groups with a computer generated arm assignment. The sealed envelopes will be opened immediately prior to nerve block. One group will receive a PENG block and the other will receive a placebo block. The provider performing the block will not be blinded, however all other members of the care team, the patient, and the investigator collecting data will be blinded to the randomization.
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| Placebo block | Procedure | Ultrasound-guided placebo injection of 5 mL 0.9% normal saline. Using the same landmarks as for the PENG group, a needle is inserted in the inguinal region under ultrasound guidance, whereby a subcutaneous injection of 5 mL of 0.9% saline is made. |
|
| Ropivacaine 0.5% Injectable Solution | Drug | 20 mL 0.5% ropivacaine will be injected for the preop PENG block |
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| Normal Saline | Drug | 5 mL 0.9% Normal saline will be injected for the Placebo block |
|
| Beginning with emergence from anesthesia and ending with discharge from the post-anesthesia care unit (typically 2 hours). |
| Nausea and Vomiting | This is a yes/no binary outcome measure defined by administration of any antiemetic drug in the post-anesthesia care unit. | Beginning with emergence from anesthesia and ending with discharge from the post-anesthesia care unit (typically 2 hours). |
| Patient satisfaction with analgesia | Patients will be called at 24 hours and 48 hours postoperatively. They will be asked during each call if they are satisfied with their pain control (binary - yes or no). | Determined through follow-up calls at 24 hours and 48-hours. |
| Postoperative opioid utilization | Cumulative postoperative opioid consumption expressed in morphine milligram equivalents | Determined through follow-up calls at 24 hours, 48 hours, and 1 week postoperatively |
| Postoperative pain scores | Postoperative numerical rating scores after discharge (0-10, where 0 is no pain, and 10 is the worst possible pain). | Determined through follow-up calls at 24 hours, 48 hours, and 1 week postoperatively |
| D012816 | Signs and Symptoms |
| D000588 |
| Amines |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |