Qena University
Qina, Qena Governorate, 83511, Egypt
NCT Number: NCT07268911
The study propose that using femoral rami obturator nerve trunk(FRONT) block may help postoperative analgesia in nail femur surgeries. The technique is relatively new, introducing one needle to target two nerve blocks in the same entry point. The block spare motor fibers of femoral nerve so it may help both early mobilization and effective analgesia, which in turn enhance early recovery and better outcomes.
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Notify Me60 year and older
All sexes
Interventional
Not applicable
Qina, Qena Governorate, 83511, Egypt
Post operative pain levels after hip fracture are high during ambulation and may worsen outcome after hip fracture. Regional anesthesia has shown to facilitate rehabilitation in orthopedics procedures. Many of these regional anesthesia techniques ,such as femoral nerve, lumber plexus, peri capsular nerve group(PENG), fascia iliaca blocks have gained attention for their opioid and some times for motor sparing potential, as well as the ability to provide targeted analgesia for anterior hip joint. Nevertheless the anterior hip joint coverage needs the constant contribution of femoral and obturator nerves to provide adequate pain relieve. In this study patients will receive preoperative femoral rami obturator nerve trunk(FRONT) block , a novel regional anesthesia technique described by Jessen et al., as a promising solution to the long-standing challenge of anesthetizing both the femoral and obturator nerve branches in anterior hip joint for postoperative pain control, addressing a more comprehensive coverage of anterior hip innervation.
Note: The protocol was amended prior to enrollment of the reported cohort. The control group was changed from multimodal analgesia alone to a sham block procedure; the primary outcome was changed from postoperative NRS pain score to time to first analgesic request; motor assessment was expanded from the Modified Bromage scale to include Manual Muscle Testing (MRC scale) and straight leg raise.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
ultrasound-guided FRONT block will be performed at the infrainguinal level, targeting the iliopsoas plane. Using the same needle approach, the subpectineal compartment will be also accessed . We will use ultrasound and electrical nerve stimulation guidance (0.4 mA, 0.1 ms, without eliciting a motor response) to avoid direct involvement of the femoral nerve. A total of 40 mL (20 mL for the iliopsoas plane and 20 mL for the subpectineal compartment) of 0.125% plain levobupivacaine will be administered.
Sham Control: Patients underwent an identical ultrasound-guided needle insertion procedure at the same anatomical sites and technique of FRONT block (iliopsoas plane and subpectineal compartment) with injection of an equivalent volume of placebo drug in the form of normal saline.
Time frame: [Time Frame: up to 36 hours postoperatively]
Description: Time in hours from spinal anesthesia to the first patient request for rescue analgesia (IV nalbuphine or ketorolac, administered when NRS > 4).
Time frame: When 36 hours postoperatively has passed.
First analgesic request time and total opioid consumption will be recorded
Time frame: Patients will be followed for 36 hours postoperatively and assessed for motor function at 2, 4, 6, 12, 18, 24, 36 hours.
assessed using Modified Bromage scale after spinal anesthesia has been resolved, where score 0 means full movement, and 4 means complete motor loss.
Time frame: Patients will be followed for 36 hours postoperatively and assessed for presence of any complications or side effects at 2, 4, 6, 12, 18, 24, 36 hours
any complication either surgical or side effects will be recorded (vomiting, allergy, urinary retention, etc.)
Time frame: Time Frame: 2, 4, 6, 12, 18, 24, 36 hours postoperatively]
Score from 0 = no pain at all to 10= worst pain imaginable, both at rest and movement
Time frame: Time Frame: 2, 4, 6, 12, 18, 24, 36 hours postoperatively
Quadriceps strength graded manually against examiner resistance using the Medical Research Council (MRC) 0-5 scale, performed by the blinded outcome assessor.
Time frame: [Time Frame: 2, 4, 6, 12, 18, 24, 36 hours postoperatively]
Description: Ability to actively raise the extended leg off the bed, assessed as a functional indicator of quadriceps/hip flexor motor recovery, performed by the blinded outcome assessor.
South Valley University
Other
Acronym: FRONT block
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.