NCT04981236

Brief Summary

Adequate pain control after total hip arthroplasty is crucial for early ambulation and patient satisfaction. The pericapsular nerve group (PENG) block has been recently introduced a new technique for blockade of the articular branches of the femoral, obturator and accessory obturator nerves. PENG block provides sufficient analgesia but it is still the potential for quadriceps weakness that might delay ambulation. Periarticular injection has attached attention as an effective analgesic modality with a low prevalence of adverse effects. The investigators will compare ultrasound-guided PENG block with periarticular injection in patients undergoing total hip arthroplasty.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 22, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 28, 2021

Completed
20 days until next milestone

Study Start

First participant enrolled

August 17, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 26, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 26, 2023

Completed
Last Updated

February 15, 2024

Status Verified

February 1, 2024

Enrollment Period

1.8 years

First QC Date

July 22, 2021

Last Update Submit

February 13, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Numeric rating scale pain score

    Pain intensity at rest evaluated by an 11-point numeric rating scale (NRS: 0 = no pain, 10 = worst imaginable pain) at 24 hours postoperatively

    at 24 hours postoperatively

Secondary Outcomes (2)

  • Numeric rating scale pain score

    at 6 hours postoperatively and 48h postoperatively

  • Quadriceps muscle strength

    at 24 hours postoperatively

Study Arms (2)

Pericapsular nerve group block

ACTIVE COMPARATOR

Participants receiving pericapsular nerve group block

Procedure: Pericapsular nerve group block

Periarticular block

EXPERIMENTAL

Participants receiving periarticular block

Procedure: Periarticular block

Interventions

A curvilinear 2-5MHz ultrasound probe will be initially placed in a transverse plane over the anterior superior iliac spine and then aligned with the pubic ramus by rotating the probe counterclockwise approximately 45 degrees. In this view, the iliopubic eminence, the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle will be observed. A 22-gauge, 80-mm needle will be inserted from lateral to medial in an in-plane approach to place the tip in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly. A total volume of 20 ml of ropivacaine 0.3% will be injected.

Also known as: PENG block
Pericapsular nerve group block

The periarticular injection solution contained 20mL of 7.5 mg/mL ropivacaine, 30mg of ketorolac, and 0.3mL of 1.0 mg/mL epinephrine. These agents were mixed with normal saline to a combined volume of 50mL. The surgeon injected this mixture into the tensor fascia lata, subcutaneous tissues, abductors, short external rotators muscles, and structures in the capsule.

Periarticular block

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 19 years old or older
  • American Society of Anesthesiologists Physical Status 1-3
  • Scheduled for elective unilateral total hip arthroplasty

You may not qualify if:

  • Allergy or intolerance to any of the drugs used in the study
  • Hepatic or renal insufficiency
  • Opioid dependency
  • Coagulopathy
  • Pre-existing neurologic or anatomic deficits in the lower extremities
  • Severe psychiatric illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Cardiac Anesthesiology, Department of Anesthesiology and Pain Medicine, Cardiovascular Hospital, Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea

Seoul, South Korea

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Yong Seon Choi

    Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2021

First Posted

July 28, 2021

Study Start

August 17, 2021

Primary Completion

May 26, 2023

Study Completion

May 26, 2023

Last Updated

February 15, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations