Anterior Hip Analgesia
Conditions
Brief summary
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.
Detailed description
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 changed from the Modified Bromage scale to Manual Muscle Testing (MRC scale) and straight leg raise, the Modified Bromage scale being discontinued; and the upper limit of ASA physical status was extended from II to III.
Interventions
PROCEDUREFemoral rami obturator nerve trunk (FRONT) block
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.
PROCEDURESham block
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.
Sponsors
South Valley University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* the elderly age≥60 years * American Society of Anesthesiologists (ASA) classification I, II, III * patients who undergoing surgery for intramedullary nail surgery.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to first postoperative analgesic request | [Time Frame: up to 36 hours postoperatively] | Description: Time in hours when the first patient request for rescue analgesia (IV nalbuphine 6 mg iv bolus) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opioid consumption | When 36 hours postoperatively has passed. | total opioid consumption will be recorded postoperatively |
| Complication | 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.) |
| Numeric Rating Scale (NRS) | 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 |
| Manual Muscle Testing (MRC scale) | 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. |
| Straight Leg Raise (SLR) test | [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. |
Countries
Egypt
Contacts
STUDY_DIRECTORZeinab M Sayed, MD
Qena University
Outcome results
None listed