Peripheral Nerve Block vs Spinal Anesthesia in Patients With Femur Fracture

Sponsor

Federico II University (Other)

Overall Status

Recruiting

CT.gov ID

NCT06155903

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

11.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Femur Fractures (PF) are nowadays one of the main social and health problems in industrialized countries. PF are defined as crack or break of the proximal femur and they represent an important cause of morbidity and mortality in elderly population.

The main prospective and retrospective studies do not show the superiority of subarachnoid anesthesia over general anesthesia in terms of 30-day mortality and post-operative complications, however they always recommend the execution of PeripheralNerve Blocks (PNB). Loco-regional anesthesia plays a fundamental role in the treatment of peri-operative pain assuring better hemodynamic stability and has already fully entered national and international pain management protocols, because it allows faster recovery times with a reduction in the use of intravenous analgesic drugs in particular opioids and consequently a faster discharge and a reduction in peri-operative complications and the costs of assistance.

The aim of our study will be to propose an anesthetic approach based on PNB that could be particularly suitable for frail patients especially when Neuroaxial Anesthesia (NA) is not feasible due to difficulty to position the patient or to the withdrawal time of anticoagulant or antiplatelet therapies.

Condition or Disease	Intervention/Treatment	Phase
Femur Fracture Peripheral Nerve Block Spinal Anesthesia	Procedure: Spinal anesthesia Procedure: Peripheral nerve blocks Drug: Anesthesiological mixtures (Spinal anesthesia) Drug: Anesthesiological mixtures (Peripheral nerve block)	N/A

Detailed Description

A venous access (16-18 G) will be placed in the operating room and antibiotic prophylaxis will be administered (Cefazolin 1 or 2 gr. iv or, in case of allergy, Clindamycin 600 mg iv). Pantoprazole 40 mg iv will also be administered. Pulse oximetry (SpO2), heart rate (HR), body temperature (C°), continuous invasive blood pressure (cIBP), brain oximetry with ForeSight will be monitored. A co-loading with 500 ml of intravenous crystalloids will be done and ondansetron 4 mg will be administered intravenously; pre-procedural sedation will be performed with Midazolam 0.01-0.03 mg/Kg. All patients in both groups will receive intraoperative sedation with Dexmedetomidine 0.4-0.7 gamma/Kg/h and o2-therapy with a nasal cannula with a flow rate of 2L/min. At this point, the type of anesthesia will be followed on the basis of the randomization group.The following variables will be evaluated:

Postoperative pain evaluated by VAS and PAINAD scales
time to motor block regression (duration of motor block)
rate of side effects (nausea, vomiting and delirum)
rescue dose analgesics needed (interval between anesthesia and first rescue dose)
surgical compliance (obtained with a 5-point Likert scale score filled out by the surgeon)
duration of surgery

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

Blind: Quadruple (participant, surgeon, investigator, outcome assessor)

Primary Purpose:

Treatment

Official Title:

Peripheral Nerve Block vs Spinal Anesthesia in Patients With Femur Fracture: A Prospective Randomized Controlled Study

Actual Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Spinal Anesthesia The participant will receive a spinal anesthesia.	Procedure: Spinal anesthesia Spinal anesthesia will be performed at the L2-L3 or L3-L4 interspace with the patients in the lateral position with the fractured side up. A small dose of local anesthetic will be injected into the skin at the planned site of insertion. More local anesthetic will be then administered along the intended path of the spinal needle insertion to the estimated depth of the supraspinous ligament. This serves a dual purpose: additional anesthesia for the spinal needle insertion and identification of the correct path for spinal needle placement. The technique will be performed aseptically in the subarachnoid space after observing clear Cephalo-Spinal Fluid (CSF) in the spinal needle 25 Gauge, and without releasing the CSF. Selected patients will be received Hypobaric Bupivacaine 0.5% 10 mg and Sufentanil 5 µg and will be maintained the lateral position for 15 min. At the end of these they will be gently placed in supine position. Drug: Anesthesiological mixtures (Spinal anesthesia) The anesthesia mixtures were injected into the subarachnoid space for spinal anesthesia. It consisted of the following local anesthetics and adjuvants: Hypobaric Bupivacaine 0.5% 10 mg and Sufentanil 5 µg.
Active Comparator: Peripheral nerve block The participant will receive a combination of femoral nerve block, sciatic nerve block with parasacral approach, lateral femoral cutaneous nerve block and obturator nerve block.	Procedure: Peripheral nerve blocks In this group, four nerve blocks will be associated to ensure adequate anesthesia and analgesia during surgery. Sciatic nerve blocks with para sacral approach will be performed with a needle connected to an electrical nerve stimulation. The needle will be advanced until contraction of the related muscles. Next, an anesthetic solution of Ropivacaine 0.375% (dose 37.5 mg) plus Mepivacaine 1% (dose 100 mg) and Dexamethasone 4mg, total volume 21 ml, will be injected. Lateral femoral cutaneous, femoral and obturator nerve blocks, femoral will be performed with the ultrasound technique. After identifying the nerves, a needle will be inserted with an "in plane" approach and will be injected. The anesthesia mixture will consist for all of :Ropivacaine 0.375% (dose 9.375 mg) plus Mepivacaine 1% (dose 25 mg). The volumes of the 3 anesthesia mixtures will be respectively: 1ml, 15ml,5ml. Drug: Anesthesiological mixtures (Peripheral nerve block) The anesthesia mixtures were injected into selected peripheral nerves . It consisted of the following local anesthetics and adjuvants: Ropivacaine 0.375% plus Mepivacaine 1% and Dexamethasone 4 mg.

Arm

Intervention/Treatment

Active Comparator: Spinal Anesthesia

The participant will receive a spinal anesthesia.

Procedure: Spinal anesthesia

Spinal anesthesia will be performed at the L2-L3 or L3-L4 interspace with the patients in the lateral position with the fractured side up. A small dose of local anesthetic will be injected into the skin at the planned site of insertion. More local anesthetic will be then administered along the intended path of the spinal needle insertion to the estimated depth of the supraspinous ligament. This serves a dual purpose: additional anesthesia for the spinal needle insertion and identification of the correct path for spinal needle placement. The technique will be performed aseptically in the subarachnoid space after observing clear Cephalo-Spinal Fluid (CSF) in the spinal needle 25 Gauge, and without releasing the CSF. Selected patients will be received Hypobaric Bupivacaine 0.5% 10 mg and Sufentanil 5 µg and will be maintained the lateral position for 15 min. At the end of these they will be gently placed in supine position.

Drug: Anesthesiological mixtures (Spinal anesthesia)

The anesthesia mixtures were injected into the subarachnoid space for spinal anesthesia. It consisted of the following local anesthetics and adjuvants: Hypobaric Bupivacaine 0.5% 10 mg and Sufentanil 5 µg.

Active Comparator: Peripheral nerve block

The participant will receive a combination of femoral nerve block, sciatic nerve block with parasacral approach, lateral femoral cutaneous nerve block and obturator nerve block.

Procedure: Peripheral nerve blocks

In this group, four nerve blocks will be associated to ensure adequate anesthesia and analgesia during surgery. Sciatic nerve blocks with para sacral approach will be performed with a needle connected to an electrical nerve stimulation. The needle will be advanced until contraction of the related muscles. Next, an anesthetic solution of Ropivacaine 0.375% (dose 37.5 mg) plus Mepivacaine 1% (dose 100 mg) and Dexamethasone 4mg, total volume 21 ml, will be injected. Lateral femoral cutaneous, femoral and obturator nerve blocks, femoral will be performed with the ultrasound technique. After identifying the nerves, a needle will be inserted with an "in plane" approach and will be injected. The anesthesia mixture will consist for all of :Ropivacaine 0.375% (dose 9.375 mg) plus Mepivacaine 1% (dose 25 mg). The volumes of the 3 anesthesia mixtures will be respectively: 1ml, 15ml,5ml.

Drug: Anesthesiological mixtures (Peripheral nerve block)

The anesthesia mixtures were injected into selected peripheral nerves . It consisted of the following local anesthetics and adjuvants: Ropivacaine 0.375% plus Mepivacaine 1% and Dexamethasone 4 mg.

Outcome Measures

Primary Outcome Measures

Postoperative pain evaluated by VAS scales [Every 6 hours during treatment until the first 24 postoperative hours]
The VAS assessment will be done with a 10-cm-long line with verbal anchors at both ends ("no pain" on the far left and "the most intense pain" on the far right). The patient will mark a dot on the line corresponding to the pain intensity rating.
Postoperative pain evaluated by PAINAD scales [Every 6 hours during treatment until the first 24 postoperative hours]
The PAINED scale (Pain Assessment in Advanced Dementia Scale) assesses 5 items: facial expression, breathing, negative vocalizations, consolability and body language with a range from 0 to 10 (1-3=mild pain; 4-6=moderate pain; 7-10=severe pain).

Secondary Outcome Measures

Rate of postoperative nausea and vomiting (PONV) [Every 6 hours during treatment until the first 24 postoperative hours]
We will analyze the risk factors of postoperative nausea and vomiting (PONV) by administering an Apfel score to each patient, practicing intraoperative and postoperative antiemetic treatment in accordance with the 2020 Fourth Consensus Guidelines for the Management of Postoperative Nausea and Vomiting.
rescue dose analgesics needed [From the end of treatment to 24 hours postoperatively]
interval between anesthesia and first rescue dose.Pharmacological therapy will be based on the patients' responses. After surgery, we will administer intravenous paracetamol 1 g 3 times a day. Ketorolac 30 mg (not for glomerular filtration rate < 50 ml/min) or Oxycodone (up to 0.1mg/Kg) mg will be available as rescue dose. Pain control will be considered good in case of VAS and PAINED score less than or equal to 4.
surgical compliance [1 hours after surgery]
will be obtained with a 5-point Likert scale score filled out by the surgeon.
The duration of surgery (min) [4 hours after skin incision]
The duration of surgery (min), assessed as Planned time(min) and Effective time(min)
Rate of Delirium [Every 6 hours during treatment until the first 24 postoperative hours]
Postoperative delirium (POD) is an acute and fluctuating alteration of mental state of reduced awareness and disturbance of attention, which begins in the recovery room and occurs up to 5 days after surgery. POD will be detected by "3-Minute Diagnostic Confusion Assessment Method" (3D-CAM) and has four features: (1) altered mental status/fluctuating course, (2) inattention, (3) altered level of consciousness, and (4) disorganized thinking [27]. For the prevention and treatment of POD, we will follow the 2017 European Society of Anesthesiology guidelines.

Other Outcome Measures

Time to motor block regression (duration of motor block) [Motor block was assessed immediately after the locoregional procedure, up to 24 hours postoperatively.]
Time to motor block regression (duration of motor block), defined as the time between complete block (score 1) after T0 of local anesthetic injection and no motor block (score 4) on the Bromage scale (1, complete motor block, unable to move feet or knees; 2, almost complete motor block, able to move the feet only; 3, partial motor block, just able to move the knees; 4, none, full flexion of knees and feet;). Motor block will be evaluated before and 10, 15 and 20min after T0, and thereafter, every 30 minutes during surgery, and every hour in the postoperative period until its complete regression

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

"Inclusion Criteria" :

Subject has signed and dated an Informed Consent Form
Subject is classified as a ASA (American Society of Anesthesiologists) status I-IV
Subject is age over 65 years old
Subjects with femur fracture, candidates for intramedullary nailing surgery, to be operated on within 48 hoursPatients undergoing total hip arthroplasty

"Exclusion Criteria":

Age younger than 65 years
Subject with contraindications to subarachnoid technique or peripherical nerve blocks
Subject with local anesthetic allergy
Subject in whom the treatment protocol could not be fully applied were excluded from this study.
Study refusal
Neurological disease of the lower limbs