Back to resultsPENG Block for Arthroscopic Hip Surgery (PENG)
Primary Purpose
Postoperative Pain, Hip Arthroscopy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Preop PENG block
Placebo block
Ropivacaine 0.5% Injectable Solution
Normal Saline
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain focused on measuring pericapsular nerve group block, PENG, hip arthroscopy, pain
Eligibility Criteria
Inclusion Criteria:
- Patients > 18 years old undergoing unilateral hip arthroscopy at the outpatient surgery center.
Exclusion Criteria:
- refusal to participate
- < 18 yo
- Chronic opioid use
- localized infection
Sites / Locations
- UVA Outpatient Surgery Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Preop PENG Block
Placebo
Arm Description
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 The needle is withdrawn, and the needle entry site wiped clean.
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.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
Nausea and Vomiting
This is a yes/no binary outcome measure defined by administration of any antiemetic drug in the post-anesthesia care unit.
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).
Postoperative opioid utilization
Cumulative postoperative opioid consumption expressed in morphine milligram equivalents
Postoperative pain scores
Postoperative numerical rating scores after discharge (0-10, where 0 is no pain, and 10 is the worst possible pain).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04508504
Brief Title
PENG Block for Arthroscopic Hip Surgery
Acronym
PENG
Official Title
Pericapsular Nerve Group (PENG) Block for Arthroscopic Hip Surgery: A Randomized, Placebo-controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
February 1, 2022 (Actual)
Study Completion Date
February 8, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Hip Arthroscopy
Keywords
pericapsular nerve group block, PENG, hip arthroscopy, pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, double blind, placebo controlled
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Preop PENG Block
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Preop PENG block
Other Intervention Name(s)
Pericapsular nerve group block
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Placebo block
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine 0.5% Injectable Solution
Intervention Description
20 mL 0.5% ropivacaine will be injected for the preop PENG block
Intervention Type
Drug
Intervention Name(s)
Normal Saline
Intervention Description
5 mL 0.9% Normal saline will be injected for the Placebo block
Primary Outcome Measure Information:
Title
PACU pain score
Description
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).
Time Frame
Within 30 minutes of emergence from anesthesia.
Secondary Outcome Measure Information:
Title
PACU opioid consumption
Description
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.
Time Frame
Beginning with emergence from anesthesia and ending with discharge from the post-anesthesia care unit (typically 2 hours).
Title
Nausea and Vomiting
Description
This is a yes/no binary outcome measure defined by administration of any antiemetic drug in the post-anesthesia care unit.
Time Frame
Beginning with emergence from anesthesia and ending with discharge from the post-anesthesia care unit (typically 2 hours).
Title
Patient satisfaction with analgesia
Description
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).
Time Frame
Determined through follow-up calls at 24 hours and 48-hours.
Title
Postoperative opioid utilization
Description
Cumulative postoperative opioid consumption expressed in morphine milligram equivalents
Time Frame
Determined through follow-up calls at 24 hours, 48 hours, and 1 week postoperatively
Title
Postoperative pain scores
Description
Postoperative numerical rating scores after discharge (0-10, where 0 is no pain, and 10 is the worst possible pain).
Time Frame
Determined through follow-up calls at 24 hours, 48 hours, and 1 week postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients > 18 years old undergoing unilateral hip arthroscopy at the outpatient surgery center.
Exclusion Criteria:
refusal to participate
< 18 yo
Chronic opioid use
localized infection
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter E Amato, MD
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
UVA Outpatient Surgery Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30063657
Citation
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.
Results Reference
background
PubMed Identifier
35998937
Citation
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.
Results Reference
derived
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PENG Block for Arthroscopic Hip Surgery
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