NCT05710107

Brief Summary

This study will consist of patients 18 years and older who are undergoing elective hip replacement with planned same day discharge. The patients will be randomized to receive a PENG+LFC or QL block prior to undergoing the surgery to help with postoperative pain control. The primary goal will be assessing postoperative opioid use during the first 72 hours after surgery. Secondary outcomes will include postoperative pain scores from, 0-72 hours. Additional outcomes consist of time to first ambulation, functional and mobility outcomes, PACU duration, patient satisfaction and opioid related side effects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2023

Shorter than P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 2, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

February 7, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 12, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 12, 2023

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

December 20, 2024

Completed
Last Updated

December 20, 2024

Status Verified

November 1, 2024

Enrollment Period

9 months

First QC Date

January 12, 2023

Results QC Date

May 14, 2024

Last Update Submit

November 13, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Postoperative Cumulative Opioid Consumption

    The primary outcome will be postoperative cumulative opioid consumption (in IV morphine mg equivalents: IV MME) over time, from 0-72 hours postoperatively. Cumulative opioid consumption will be evaluated at PACU, and through 72 hours post-op.

    0-72 hours postoperatively

Secondary Outcomes (1)

  • Average Postoperative Pain Score

    0-72 hours postoperatively

Other Outcomes (5)

  • Time to First Ambulation

    From anesthesia stop time to first ambulation in minutes, assessed up to 7 days post-op.

  • PROMIS Physical Health

    Up to 6 weeks post-operatively

  • Overall Hip Health

    Up to 6 weeks post-operatively

  • +2 more other outcomes

Study Arms (2)

PENG + LFC Block

ACTIVE COMPARATOR

The pericapsular nerve group (PENG) block is an ultrasound-guided approach, first described by Giron-Arango et al. for the blockade of the articular branches of the femoral, obturator and accessory obturator nerves that provide sensory innervation to the anterior hip capsule \[5,6\]. In the PENG block, a low-frequency, curvilinear probe is used to visualize the anterior inferior iliac spine, iliopsoas tendon, and iliopubic eminence. After placing a subcutaneous skin wheel with lidocaine, a blunt regional anesthesia needle is inserted using in-plane ultrasound guidance. The needle is advanced until the tip lies on the lateral and inferior margin of the iliopsoas tendon between the anterior inferior iliac spine (lateral) and iliopubic eminence (deep).

Other: PENG + LFC Block

QL Block

ACTIVE COMPARATOR

The lateral QL block is performed by injecting local anesthetic deep to the transversus abdominis aponeurosis and superficial to the fascia transversalis with direct ultrasound guidance. After completing consent, placing monitors and providing mild sedation, the patient is positioned laterally and the muscular anatomy (external oblique, internal oblique, transverse abdominis, quadratus lumborum and latissimus dorsi muscles) identified. After placing a subcutaneous skin wheel with lidocaine, a blunt regional anesthesia needle is inserted using in-plane ultrasound guidance. Local anesthetic is deposited incrementally with frequent aspiration in the anterolateral border of the quadratus lumborum muscle at the junction of the transversalis fascia, outside the anterior layer of the thoracolumbar fascia and superficial to the fascia transversalis.

Other: QL Block

Interventions

Subjects assigned to this group will receive PENG + LFC Block

PENG + LFC Block

Subjects randomized to this group will receive a QL Block

QL Block

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age greater than or equal to 18 years of age
  • undergoing elective hip arthroplasty with planned same day discharge

You may not qualify if:

  • local anesthetic allergy
  • subjects with a weight less than 40kg
  • subjects that are unable or choose not to give informed consent
  • Known preoperative substance abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MUSC

Charleston, South Carolina, 29425, United States

Location

Related Publications (1)

  • Hay E, Kelly T, Wolf BJ, Hansen E, Brown A, Lautenschlager C, Wilson SH. Comparison of pericapsular nerve group and lateral quadratus lumborum blocks on cumulative opioid consumption after primary total hip arthroplasty: a randomized controlled trial. Reg Anesth Pain Med. 2024 Oct 10:rapm-2024-105875. doi: 10.1136/rapm-2024-105875. Online ahead of print.

MeSH Terms

Conditions

Bites and StingsPain, Postoperative

Condition Hierarchy (Ancestors)

PoisoningChemically-Induced DisordersWounds and InjuriesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Results Point of Contact

Title
Ellen Johnson
Organization
Medical University of South Carolina

Study Officials

  • Ellen Hay, MD

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
Subjects, surgeons, and data collectors will all be blinded to the allocated group. Unblinded personnel will be the Anesthesia Attending placing the block and clinical staff assisting.
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 12, 2023

First Posted

February 2, 2023

Study Start

February 7, 2023

Primary Completion

November 12, 2023

Study Completion

November 12, 2023

Last Updated

December 20, 2024

Results First Posted

December 20, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations