- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05968014
Quality of Recovery After Hip Fracture Surgery: US-guided PENG Block Versus FICB
Quality of Recovery After Hip Fracture Surgery: Ultrasound-guided Pericapsular Nerve Group Block Versus Fascia Iliaca Compartment Block
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Mrezga
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Nabeul, Mrezga, Tunisia, 8000
- Nabeul hospital, Mohamed Taher Maamouri
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PENG block
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.
|
pericapsular nerve group block versus fascia iliaca compartment block
|
Experimental: FIC block
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.
|
pericapsular nerve group block versus fascia iliaca compartment block
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Quality of Recovery-15 scores at 24 hours postoperatively.
Time Frame: before and 24 hours after surgery
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The strength of the quadriceps
Time Frame: 24 hours after surgery
|
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.
|
24 hours after surgery
|
Visual analogue scale
Time Frame: 24 hours after surgery
|
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.
|
24 hours after surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Chaima Debabi, University Tunis El Manar
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Chaima Debabi
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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