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

NCT05968014 | Completed

• 1 other identifier: Chaima Debabi
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Enhanced Recovery After Surgery

Keywords

hip fracture surgery; PENG block; fascia iliaca compartment block; quality of recovery

Outcome Measures

Primary Outcomes (1)

• 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.

  before and 24 hours after surgery

Secondary Outcomes (2)

• The strength of the quadriceps

  24 hours after surgery

• Visual analogue scale

  24 hours after surgery

Study Arms (2)

PENG block

EXPERIMENTAL

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.

Procedure: PENG vs FICB

FIC block

EXPERIMENTAL

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.

Procedure: PENG vs FICB

Interventions

PENG vs FICB PROCEDURE

pericapsular nerve group block versus fascia iliaca compartment block

FIC block; PENG block

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• patients aged above 65 years
• patients with an american society of anesthesiologists physical status I to III
• patients undergoing hip fracture surgical repair

You may not qualify if:

• 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

Sponsors & Collaborators

• University Tunis El Manar: lead

Study Sites (1)

Nabeul hospital, Mohamed Taher Maamouri

Nabeul, Mrezga, 8000, Tunisia

Location

Study Officials

• Chaima Debabi

  University Tunis El Manar

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: July 11, 2023
• First Posted: August 1, 2023
• Study Start: February 1, 2022
• Primary Completion: July 31, 2022
• Study Completion: July 31, 2022
• Last Updated: March 5, 2024

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)