Pericapsular Nerve Group (PENG) Block Combined With Periarticular Multimodal Drug Injection (PMDI) Versus Isolated PMDI for Pain Management After Total Hip Arthroplasty: a Randomized Controlled Trial

Adequate pain control after total hip arthroplasty is crucial for early ambulation and patient satisfaction. However, there is no consensus about optimal pain control after post operation. In general, the periarticular multimodal durg injection block has been done for pain control in primary total hip arthroplasty. 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 is possible to provide sufficient analgesia and preserve lower limb muscle strength. The investigators will compare PENG and PMDI block with isolated PMDI block in patients undergoing total hip arthroplasty.

Study Overview

• Status: Recruiting
• Conditions: Total Hip Arthroplasty, Postoperative Pain
• Intervention / Treatment: Procedure: Pericapsular nerve group(PENG) block combined with periarticular multimodal drug injection (PMDI); Procedure: isolated periarticular multimodal drug injection (PMDI)

• Study Type: Interventional
• Enrollment (Anticipated): 58
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kwankyu Park; Phone Number: 82-2-2228-2183; Email: kkpark@yuhs.ac

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Yonsei University Health system, Severance Hospital
    • Contact: Kwankyu Park; Phone Number: 82-2-2228-2183; Email: kkpark@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients aged 19 years old or older, with American Society of Anesthesiologists Physical Status 1-3, and scheduled for elective unilateral total hip arthroplasty

Exclusion Criteria:

1. Allergy or intolerance to any of the drugs used in the study
2. Hepatic or renal insufficiency
3. Opioid dependency
4. Coagulopathy
5. Pre-existing neurologic or anatomic deficits in the lower extremities
6. Severe psychiatric illness

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pericapsular nerve group(PENG) block combined with periarticular multimodal drug injection (PMDI); Participants receiving pericapsular nerve group(PENG) block combined with periarticular multimodal drug injection (PMDI)	Procedure: Pericapsular nerve group(PENG) block combined with periarticular multimodal drug injection (PMDI); periarticular local anesthetic infiltration with 120 mg of ropivacaine, epinephrine 0.2 mg and 30 mg of ketorolac diluted with normal saline to a total volume of 40 mL. + PENG block with ropivacaine 40 mg and epinephrine 0.1 mg with normal saline to a total volume of 20 mL; Other Names: PENG + PMDI block
Active Comparator: isolated periarticular multimodal drug injection (PMDI); Arm Description: Participants receiving isolated periarticular multimodal drug injection (PMDI)	Procedure: isolated periarticular multimodal drug injection (PMDI); periarticular local anesthetic infiltration with 150 mg of ropivacaine, epinephrine 0.3 mg and 30 mg of ketorolac diluted with normal saline to a total volume of 50 mL; Other Names: Isolated PMDI block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain score measured at 6 hours postoperatively and 48 hours postoperatively	Pain intensity at rest evaluated by an 11-point numeric rating scale (NRS: 0 = no pain, 10 = worst imaginable pain) at 6 hours postoperatively and 48h postoperatively	Pain score measured at 6 hours postoperatively and 48 hours postoperatively

Collaborators and Investigators

• Sponsor: Yonsei University
• Investigators: Principal Investigator: Kwankyu Park, Department of orthopaedic surgery, Yonsei University College of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2022
• Primary Completion (Anticipated): December 13, 2023
• Study Completion (Anticipated): December 13, 2023

Study Registration Dates

• First Submitted: April 3, 2022
• First Submitted That Met QC Criteria: April 8, 2022
• First Posted (Actual): April 11, 2022

Study Record Updates

• Last Update Posted (Actual): May 3, 2022
• Last Update Submitted That Met QC Criteria: May 2, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 4-2021-1482

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No