PENG Block for Arthroscopic Hip Surgery

Postoperative Pain Clinical Trial

— PENG  

Official title:

Pericapsular Nerve Group (PENG) Block for Arthroscopic Hip Surgery: A Randomized, Placebo-controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04508504
• Other study ID #: HSR200214
• Status: Completed
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: February 8, 2022

Study information

• Verified date: March 2022
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: February 8, 2022
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hip Arthroscopy
• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• Preop PENG block
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.
• Placebo block
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.

Drug:
• Ropivacaine 0.5% Injectable Solution
20 mL 0.5% ropivacaine will be injected for the preop PENG block
• Normal Saline
5 mL 0.9% Normal saline will be injected for the Placebo block

Locations

Country	Name	City	State
United States	UVA Outpatient Surgery Center	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

References & Publications (1)

Girón-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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Secondary	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.	Beginning with emergence from anesthesia and ending with discharge from the post-anesthesia care unit (typically 2 hours).
Secondary	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).
Secondary	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.
Secondary	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
Secondary	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