Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT05393726 |
Other study ID # |
AP2203-301-008 |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
December 15, 2023 |
Est. completion date |
December 15, 2024 |
Study information
Verified date |
November 2023 |
Source |
National Cancer Institute, Egypt |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
This is a prospective; double blinded randomized controlled trial that will be conducted on
cancer patients subjected to oncologic thigh surgery.The aim of this study is to evaluate and
compare the analgesic effect of supra-inguinal fascia iliaca block and lumbar erector spinae
plane block in oncologic thigh surgery.Patients will be randomized into three equal
comparable groups, Group A (Ultrasound-guided supra-inguinal fascia iliaca block (SIFIB)),
Group B (Ultrasound-guided lumbar erector spinae plane block (L-ESPB)), and Group C (control
group). Primary outcome parameter is the total postoperative morphine consumption over the
first 24 hours postoperative. Data will be analyzed using IBM SPSS 26 (SPSS Inc., Chicago,
IL).
Description:
Pain is one of the most common and significant postoperative events experienced by many
surgical patients. Orthopedic surgery is a relatively painful surgery due to the significant
amount of bone and soft tissue resection, damage, and reconstruction. After thigh surgery for
sarcomas, the patient may experience any of three distinct types of pain, including acute
postoperative pain, persistent long-term nociceptive pain, and neuropathic pain related to
intraoperative nerve injuries. The management of pain in limb sparing surgery patients and
amputated patients is crucial during the rehabilitation program and often its approach is
multidisciplinary. The ultrasound-guided supra-inguinal fascia iliaca block further built on
earlier anatomic discoveries to more reliably anesthetize the three nerves: femoral, lateral
femoral cutaneous, and obturator. The supra-inguinal fascia iliaca block has evolved as an
effective means of providing analgesia to the thigh, the knee, and, most notably, the hip.
Ultrasound-guided erector spinae plane block (ESPB) is an interfascial plane block reported
in the treatment of postoperative pain from surgical procedures, ranging from shoulder to hip
surgery. When performed at the lumbar 4th vertebral level, ESPB led to sensorial blockage
between Th12 and L4 dermatomes lead to effective postoperative analgesia in hip and proximal
femoral surgery. Although supra-inguinal fascia iliaca block and L-ESPB successfully reduced
postoperative opioid consumption in previous study, no study has ever compared their efficacy
in postoperative analgesia of adult patients undergoing oncologic thigh surgery under general
anesthesia. Thus, in this randomized comparative study we are aiming to fill this gape in the
literature.