Health TrialsbyHealthPanel

Femoral Rami Obturator Nerve Trunk (FRONT) Block in Intramedullary Nail Surgery .

ConditionAnterior Hip Analgesia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorSouth Valley University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

the elderly age≥60 years

American Society of Anesthesiologists (ASA) classification 1-2

patients who undergoing surgery for intramedullary nail surgery.

Disqualifiers

patient refused to participate and consent

patients with a history of mild cognitive impairment (MCI), dementia, and delirium

patients with known preoperative infections (pulmonary infection, urinary infection, and sepsis).

coagulopathy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Femoral rami obturator nerve trunk (FRONT) block

    Procedure/Surgery

    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.

  • Multimodal systemic analgesia

    Drug

    Standard postoperative protocol: * IV nalbuphine (6 mg bolus PRN when NRS\>4 ) * IV paracetamol 1g every 6 hours * IV ketorolac 30 mg every 8 hours PRN (NRS \>4)

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: FRONT BlockExperimental treatment 1 intervention
Group B: Conventional AnalgesiaActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Postoperative analgesia

Pain level will be assessed after spinal anesthesia is resolved using rest/dynamic numeric rating scale (NRS) with patients rating their pain on a scale from 0 to 10. On this scale, 0 means "no pain" and 10 means "the worst pain imaginable"

Time frame
Patients will be followed for 36 hours postspinal and assessed for pain, at 2, 4, 6, 12, 18, 24, 36 hours

Secondary outcomes

1

Opioid consumption

First analgesic request time and total opioid consumption will be recorded

Time frame
When 36 hours postoperatively has passed.
2

Motor function

Motor function will be 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 motor function at 2, 4, 6, 12, 18, 24, 36 hours.
3

Complication

any complication either surgical or side effects will be recorded (vomiting, allergy, urinary retention, etc.)

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

South Valley University

Lead sponsor

Source ClinicalTrials.gov
Apply now