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Quality of Recovery After Hip Fracture Surgery: US-guided PENG Block Versus FICB

Primary Purpose

Enhanced Recovery After Surgery

Status
Completed
Phase
Not Applicable
Locations
Tunisia
Study Type
Interventional
Intervention
PENG vs FICB
Sponsored by
University Tunis El Manar
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Enhanced Recovery After Surgery focused on measuring hip fracture surgery, PENG block, fascia iliaca compartment block, quality of recovery

Eligibility Criteria

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

Inclusion Criteria: patients aged above 65 years patients with an american society of anesthesiologists physical status I to III patients undergoing hip fracture surgical repair Exclusion Criteria: patients with an american society of anesthesiologists physical status IV or more inability or refusal to sign informed consent contraindications for regional nerve block or spinal anesthesia impaired cognition or dementia

Sites / Locations

  • Nabeul hospital, Mohamed Taher Maamouri

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

PENG block

FIC block

Arm Description

Participants enrolled in this group received a pericapsular nerve group block with 20 ml of 0.2% ropivacaine. The block was performed with a 100 mm needle, inserted with an in-plane lateral to medial approach. Operator used a low frequency curvilinear probe.

Patients allocated in this group received a fascia iliaca compartment block with 20 mL of 0.2% ropivacaine, using a 50 mm needle inserted with an in-plane approach. Operator used a linear probe.

Outcomes

Primary Outcome Measures

The Quality of Recovery-15 scores at 24 hours postoperatively.
Change in Quality of Recovery-15 (QoR-15) scores before and 24 hours after surgery. The QoR-15 score consists of 15 items, and includes five dimensions: pain (two items), physical confort (five items), physical independance (two items), psychological support (two items) and emotional state (four items). Each item's score ranged from 0 to 10, and the total score ranged from 0 to 150, with a higher QoR-15 score indicating a better quality of recovery.

Secondary Outcome Measures

The strength of the quadriceps
The strength of the quadriceps muscle was measured 24 hours after surgery. It was determined by testing the movement of the knee and the hip.
Visual analogue scale
change in visual analogue scale ((VAS) with 0 indicating no pain and 10 indicating the worst imaginable pain) at rest and on movement on postoperative day 1.

Full Information

First Posted
July 11, 2023
Last Updated
July 22, 2023
Sponsor
University Tunis El Manar
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1. Study Identification

Unique Protocol Identification Number
NCT05968014
Brief Title
Quality of Recovery After Hip Fracture Surgery: US-guided PENG Block Versus FICB
Official Title
Quality of Recovery After Hip Fracture Surgery: Ultrasound-guided Pericapsular Nerve Group Block Versus Fascia Iliaca Compartment Block
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
July 31, 2022 (Actual)
Study Completion Date
July 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Tunis El Manar

4. Oversight

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

5. Study Description

Brief Summary
Patients were randomly divided into two groups to receive either ultrasound-guided pericapsular nerve group block (PENG group) or fascia iliaca compartment block (FICB group), using 20 ml of 0.2% ropivacaine
Detailed Description
Participants were randomly divided into two groups : group PENG and group FICB, to receive either ultrasound-guided pericapsular nerve group block or fascia iliaca compartment block, using 50 ml of 0.2% ropivacaine. For the FICB, a linear ultrasound probe was placed in the transverse plane and start scanning at the level of the inguinal crease to identify the femoral artery medially and the femoral nerve lateral to the femoral artery. The iliopsoas muscle should be seen overlying fascia iliaca. The block should be performed proximal to the arterial bifurcation. A 50 mm needle was introduced using an in-plane approach to penetrate the fascia iliaca. The hydro dissection separate the fascia iliaca from the iliac muscle, and a total volume of 20 ml of 0.2% ropivacaine was injected in this created space. The PENG bloc is performed with a low frequency curvilinear ultrasound probe, which was initially placed in a transverse plane over the antero inferior iliac spine and the aligned with the pubic ramus by rotating the probe counterclockwise approximately 45 degrees. In this view, it is possible to observe the iliopubic eminence, the iliopsoas muscle tendon, the femoral artery and the pectineus muscle. A 100 mm needle was inserted from lateral to medial in an in-plane approach to place the tip in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly. Negative aspiration should be observed before injection of local anaesthetic and a total volume of 20 ml of 0.2% ropivacaine was injected. Spinal anesthesia was performed after 20 minutes. QoR-15 score was assessed before the intervention and 24 hours postoperatively.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Enhanced Recovery After Surgery
Keywords
hip fracture surgery, PENG block, fascia iliaca compartment block, quality of recovery

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomised-controlled trial with two parallel study groups. Participants will be randomised 1:1 to the PENG group or FICB group. The PENG group was treated with PENG block following randomisation, whereas the FICB group received a fascia iliaca compartment block.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PENG block
Arm Type
Experimental
Arm Description
Participants enrolled in this group received a pericapsular nerve group block with 20 ml of 0.2% ropivacaine. The block was performed with a 100 mm needle, inserted with an in-plane lateral to medial approach. Operator used a low frequency curvilinear probe.
Arm Title
FIC block
Arm Type
Experimental
Arm Description
Patients allocated in this group received a fascia iliaca compartment block with 20 mL of 0.2% ropivacaine, using a 50 mm needle inserted with an in-plane approach. Operator used a linear probe.
Intervention Type
Procedure
Intervention Name(s)
PENG vs FICB
Intervention Description
pericapsular nerve group block versus fascia iliaca compartment block
Primary Outcome Measure Information:
Title
The Quality of Recovery-15 scores at 24 hours postoperatively.
Description
Change in Quality of Recovery-15 (QoR-15) scores before and 24 hours after surgery. The QoR-15 score consists of 15 items, and includes five dimensions: pain (two items), physical confort (five items), physical independance (two items), psychological support (two items) and emotional state (four items). Each item's score ranged from 0 to 10, and the total score ranged from 0 to 150, with a higher QoR-15 score indicating a better quality of recovery.
Time Frame
before and 24 hours after surgery
Secondary Outcome Measure Information:
Title
The strength of the quadriceps
Description
The strength of the quadriceps muscle was measured 24 hours after surgery. It was determined by testing the movement of the knee and the hip.
Time Frame
24 hours after surgery
Title
Visual analogue scale
Description
change in visual analogue scale ((VAS) with 0 indicating no pain and 10 indicating the worst imaginable pain) at rest and on movement on postoperative day 1.
Time Frame
24 hours after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients aged above 65 years patients with an american society of anesthesiologists physical status I to III patients undergoing hip fracture surgical repair Exclusion Criteria: patients with an american society of anesthesiologists physical status IV or more inability or refusal to sign informed consent contraindications for regional nerve block or spinal anesthesia impaired cognition or dementia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chaima Debabi
Organizational Affiliation
University Tunis El Manar
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nabeul hospital, Mohamed Taher Maamouri
City
Nabeul
State/Province
Mrezga
ZIP/Postal Code
8000
Country
Tunisia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Quality of Recovery After Hip Fracture Surgery: US-guided PENG Block Versus FICB

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