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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05968014
Other study ID # Chaima Debabi
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2022
Est. completion date July 31, 2022

Study information

Verified date July 2023
Source University Tunis El Manar
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date July 31, 2022
Est. primary completion date July 31, 2022
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
PENG vs FICB
pericapsular nerve group block versus fascia iliaca compartment block

Locations

Country Name City State
Tunisia Nabeul hospital, Mohamed Taher Maamouri Nabeul Mrezga

Sponsors (1)

Lead Sponsor Collaborator
University Tunis El Manar

Country where clinical trial is conducted

Tunisia, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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. 24 hours after surgery
Secondary 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. 24 hours after surgery
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