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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

Primary Purpose

Total Hip Arthroplasty, Postoperative Pain

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Pericapsular nerve group(PENG) block combined with periarticular multimodal drug injection (PMDI)
isolated periarticular multimodal drug injection (PMDI)
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Total Hip Arthroplasty, Postoperative Pain

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Yonsei University Health System, Severance HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pericapsular nerve group(PENG) block combined with periarticular multimodal drug injection (PMDI)

isolated periarticular multimodal drug injection (PMDI)

Arm Description

Participants receiving pericapsular nerve group(PENG) block combined with periarticular multimodal drug injection (PMDI)

Arm Description: Participants receiving isolated periarticular multimodal drug injection (PMDI)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 3, 2022
Last Updated
May 2, 2022
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT05320913
Brief Title
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
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 4, 2022 (Actual)
Primary Completion Date
December 13, 2023 (Anticipated)
Study Completion Date
December 13, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Total Hip Arthroplasty, Postoperative Pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
58 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pericapsular nerve group(PENG) block combined with periarticular multimodal drug injection (PMDI)
Arm Type
Experimental
Arm Description
Participants receiving pericapsular nerve group(PENG) block combined with periarticular multimodal drug injection (PMDI)
Arm Title
isolated periarticular multimodal drug injection (PMDI)
Arm Type
Active Comparator
Arm Description
Arm Description: Participants receiving isolated periarticular multimodal drug injection (PMDI)
Intervention Type
Procedure
Intervention Name(s)
Pericapsular nerve group(PENG) block combined with periarticular multimodal drug injection (PMDI)
Other Intervention Name(s)
PENG + PMDI block
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
isolated periarticular multimodal drug injection (PMDI)
Other Intervention Name(s)
Isolated PMDI block
Intervention Description
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
Primary Outcome Measure Information:
Title
Numeric rating scale pain score
Description
Pain intensity at rest evaluated by an 11-point numeric rating scale (NRS: 0 = no pain, 10 = worst imaginable pain) at 24 hours postoperatively
Time Frame
at 24 hours postoperatively
Secondary Outcome Measure Information:
Title
Pain score measured at 6 hours postoperatively and 48 hours postoperatively
Description
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
Time Frame
Pain score measured at 6 hours postoperatively and 48 hours postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kwankyu Park
Phone
82-2-2228-2183
Email
kkpark@yuhs.ac
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kwankyu Park
Organizational Affiliation
Department of orthopaedic surgery, Yonsei University College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yonsei University Health System, Severance Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kwankyu Park
Phone
82-2-2228-2183
Email
kkpark@yuhs.ac

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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