Comparison of PENG Block and FICB in Hip Fracture Patients

Hip Fractures Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04677348
• Other study ID #: 2020-1822
• Status: Completed
• Phase: N/A
• Start date: January 21, 2021
• Est. completion date: February 11, 2022

Study information

• Verified date: March 2022
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: February 11, 2022
• Est. primary completion date: January 26, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fractures
• Regional Anesthesia

Intervention

Procedure:
• Pericapsular nerve group (PENG) block
ultrasound-guided PENG block with 0.3% ropivacaine 20cc
• Fascia iliaca compartment block (FICB)
ultrasound-guided suprainguinal FICB with 0.3% ropivacaine 30cc

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	before surgery
Secondary	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.	before surgery
Secondary	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 6, 24, 48hours
Secondary	postoperative opioid consumption	morphine-equivalent dose	postoperative 24, 48hours
Secondary	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	postoperative 6, 24, 48hours
Secondary	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.	before surgery