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Comparison of PENG Block and FICB in Hip Fracture Patients

Primary Purpose

Hip Fractures, Regional Anesthesia

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Pericapsular nerve group (PENG) block

Fascia iliaca compartment block (FICB)

About this trial

This is an interventional supportive care trial for Hip Fractures focused on measuring pericapsular nerve group block, fascia iliaca compartment block, hip fracture, regional anesthesia, dynamic pain

Eligibility Criteria

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

Inclusion Criteria:

ASA PS 1-4
age: ≥19
baseline pain score (associated with hip fracture): ≥4

Exclusion Criteria:

patients who do not agree to participate in this study
patients with uncontrolled hypertension, hyperthyroidism, severe dementia
allergic to ropivacaine
contraindicated to spinal anesthesia due to coagulopathy, severe aortic stenosis/mitral stenosis, or active infection on lumbar region
patients who are considered ineligible with any other reason by investigators

Sites / Locations

Asan Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PENG group

FICB group

Arm Description

pericapsular nerve group (PENG) block before surgery

suprainguinal fascia iliaca compartment block (FICB) before surgery

Outcomes

Primary Outcome Measures

Efficacy of each block (Pain score)

We will assess the dynamic pain (pain during a movement) using NRS before and 20-30min after applying the assigned block. Then, we will calculate the change of NRS at the two time-points. NRS: Numerical rating scale (0, no pain; 10, the worst pain imaginable)

Secondary Outcome Measures

change of blood pressure (systolic, diastolic, mean blood pressure)

We will evaluate the blood pressure before and 20-30min after applying the assigned block. Then, we will calculate the change of blood pressure at the two time-points.

postoperative pain score

resting and dynamic pain using NRS at postoperative 6, 24, 48hours NRS: Numerical rating scale (0, no pain; 10, the worst pain imaginable)

postoperative opioid consumption

morphine-equivalent dose

postoperative motor function

motor function of quadriceps femoris grade5: normal power grade4: movement possible against some resistance grade3: movement against gravity but not resistance grade2: movement possible if gravity eliminated grade1: flicker of contraction possible grade0: complete paralysis

change of heart rate

We will evaluate the heart rate before and 20-30 min after applying the assigned block. Then, we will calculate the change of heart rate at the two time-points.

Full Information

NCT ID

NCT04677348

First Posted

December 10, 2020

Last Updated

March 21, 2022

Sponsor

Asan Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT04677348

Brief Title

Comparison of PENG Block and FICB in Hip Fracture Patients

Official Title

Comparison of Analgesic Effect of Pericapsular Nerve Group Block and Suprainguinal Fascia Iliaca Compartment Block on Dynamic Pain in Patients Undergoing Hip Fracture Surgery: a Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Completed

Study Start Date

January 21, 2021 (Actual)

Primary Completion Date

January 26, 2022 (Actual)

Study Completion Date

February 11, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Asan Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Fascia iliaca compartment block (FICB) has been considered the block of choice for patients with hip fracture. However, pericapsular nerve group (PENG) block, one of the relatively newly-developed blocks, could be also used for analgesia in patients with hip fracture. Since PENG block could block the accessory obturator nerve, PENG block might have greater analgesic effects compared to FICB theoretically. However, the comparison of these two blocks in patients with hip fracture has not performed in clinical setting. Thus, we aimed to compare the analgesic effect of PENG block and FICB.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hip Fractures, Regional Anesthesia

Keywords

pericapsular nerve group block, fascia iliaca compartment block, hip fracture, regional anesthesia, dynamic pain

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PENG group

Arm Type

Experimental

Arm Description

pericapsular nerve group (PENG) block before surgery

Arm Title

FICB group

Arm Type

Active Comparator

Arm Description

suprainguinal fascia iliaca compartment block (FICB) before surgery

Intervention Type

Procedure

Intervention Name(s)

Pericapsular nerve group (PENG) block

Intervention Description

ultrasound-guided PENG block with 0.3% ropivacaine 20cc

Intervention Type

Procedure

Intervention Name(s)

Fascia iliaca compartment block (FICB)

Intervention Description

ultrasound-guided suprainguinal FICB with 0.3% ropivacaine 30cc

Primary Outcome Measure Information:

Title

Efficacy of each block (Pain score)

Description

Time Frame

before surgery

Secondary Outcome Measure Information:

Title

change of blood pressure (systolic, diastolic, mean blood pressure)

Description

We will evaluate the blood pressure before and 20-30min after applying the assigned block. Then, we will calculate the change of blood pressure at the two time-points.

Time Frame

before surgery

Title

postoperative pain score

Description

resting and dynamic pain using NRS at postoperative 6, 24, 48hours NRS: Numerical rating scale (0, no pain; 10, the worst pain imaginable)

Time Frame

postoperative 6, 24, 48hours

Title

postoperative opioid consumption

Description

morphine-equivalent dose

Time Frame

postoperative 24, 48hours

Title

postoperative motor function

Description

Time Frame

postoperative 6, 24, 48hours

Title

change of heart rate

Description

We will evaluate the heart rate before and 20-30 min after applying the assigned block. Then, we will calculate the change of heart rate at the two time-points.

Time Frame

before surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: ASA PS 1-4 age: ≥19 baseline pain score (associated with hip fracture): ≥4 Exclusion Criteria: patients who do not agree to participate in this study patients with uncontrolled hypertension, hyperthyroidism, severe dementia allergic to ropivacaine contraindicated to spinal anesthesia due to coagulopathy, severe aortic stenosis/mitral stenosis, or active infection on lumbar region patients who are considered ineligible with any other reason by investigators

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Won Uk Koh, MD, PhD

Organizational Affiliation

Asan Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Asan Medical Center

City

Seoul

ZIP/Postal Code

05505

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Comparison of PENG Block and FICB in Hip Fracture Patients

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