Clinical trial NCT04506450: Peripheral Nerve Block vs Spinal Anesthesia in Hip Surgery
Official title: Peripheral Nerve Block vs Spinal Anesthesia in Hip Surgery: a Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Arthroplasty
Keywords: Regional anesthesia
Hip arthroplasty
Nerve block
Lumbar plexus block
Lead sponsor: Università Politecnica delle Marche
Sponsor class: OTHER
First posted: 2020-08-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Anesthesia plays an important role in the patient's outcome: each anesthesiological technique has a different cardiovascular impact, because they act differently on the autonomic nervous system, which in turn regulates heart rate, myocardial contractility and vascular tone.

Subarachnoid anesthesia can result in a reduction in cardiac output, hypotension and bradycardia due to blockage of the nerve fibers of the sympathetic system, while peripheral nerve block is associated with a lower impact on the autonomic nervous system, therefore less influence on hemodynamic changes compared to subarachnoid anesthesia.

Hypotension can lead to myocardial ischaemia, especially in patients at high surgical risk.

In addition, peripheral nerve block allows for better coverage from postoperative pain compared to subarachnoid anesthesia in patients undergoing hip surgery.

This leads to less postoperative stress, with less impact on cardiac and respiratory function.

Numerous studies have shown the efficacy and safety of regional anesthesia in hip surgery.

This study aims to compare the hemodynamic changes of subarachnoid anesthesia and peripheral nerve block in patients who underwent total and partial hip replacement

Detailed description: All patients who meet the inclusion and exclusion criteria will be enrolled. Enrolled patients will be informed of the study modality. In case of a favorable opinion, the patient will be made to sign the informed consent. Subsequently a code will be assigned to the patient for randomization.

There are two randomization groups: in the PNB group the patient will undergo lumbar plexus block, sciatic nerve block, lateral femoral cutaneous nerve block and lateral branch of iliohypogastric nerve block, while in the SA group, the patient will undergo subarachnoid anesthesia and lumbar plexus block.

In the preoperative room, ECG, pulseoximetry will be estabilished and an arterial radial cannula will be inserted under local anesthesia to monitor blood pressure. A premedication with midazolam (0.05-0.1 mg / kg) will be administered before anesthesia is performed.

At this point, the type of anesthesia will be followed on the basis of the randomization group.

The following variables will be evaluated:

* hemodynamic parameters in the perioperative period
* onset time of the sensory and motor block
* fluids and vasoactive drugs administered
* anesthesiological complications
* degree of patient satisfaction
* duration of surgery
* degree of postoperative pain and analgesic therapy administered
* mini mental state evaluation (in the preoperative and postoperative period)
* start physical rehabilitation
* clinical complications during hospitalization
* duration of hospitalization

Eligibility criteria: 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 18- 99 years old
* Patients undergoing total hip arthroplasty

Exclusion Criteria:

* Subject inability to provide adequate informed consent
* Study refusal
* Age younger than 18 years
* Contraindication to regional anesthesia
* Allergy to local anesthetics
* Neurological disease of the lower limbs
* Moderate or severe dementia disease
* Psychiatric disease

Primary outcomes:
measure: Change of the systolic blood pressure
timeFrame: During anesthetic and surgery procedures
measure: Change of the diastolic blood pressure
timeFrame: During anesthetic and surgery procedures
measure: Change of the mean blood pressure
timeFrame: During anesthetic and surgery procedures
measure: Change of the heart rate
timeFrame: During anesthetic and surgery procedures
Secondary outcomes:
measure: Change in the onset time of the nerve block
timeFrame: Up to 20 minutes
measure: Change in the degree of the sensory block
timeFrame: Up to 20 minutes after the end of the anesthetic procedure
measure: Change of the Motor block degree
timeFrame: Up to 20 minutes after the end of the anesthetic procedure
measure: Amount ephedrine administered during the perioperative period
timeFrame: During anesthetic and surgery procedures
measure: Amount atrophine administered during the perioperative period
timeFrame: During anesthetic and surgery procedures
measure: Amount Fluids administered during the perioperative period
timeFrame: During anesthetic and surgery procedures
measure: Degree of patient satisfaction
timeFrame: At the end of surgery
measure: Duration of surgery
timeFrame: During surgery
measure: Postoperative pain score
timeFrame: 1, 3, 6, 12, 24, 36, 48 hours after the end of surgery
measure: Amount of analgesic drugs administered
timeFrame: 1, 3, 6, 12, 24, 36, 48 hours after the end of surgery
measure: Assessment of mental state
timeFrame: Preoperative; 24 hours after the end of surgery; 48 h after the end of surgery, 72 h after the end of surgery and 96 h after the end of surgery.
measure: Beginning of physical rehabilitation
timeFrame: Immediately after the surgery
measure: Anesthetic and surgery complications
timeFrame: During anesthetic and surgery procedures
measure: Clinical complications
timeFrame: Immediately after the surgery
measure: Duration of hospitalization
timeFrame: Up to one month
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: Ospedali Riuniti di Ancona - Università politecnica delle marche
Study officials:
affiliation: Ospedali riuniti di Ancona-Università politecnica delle Marche
name: Diego Tavoletti, MD
role: PRINCIPAL_INVESTIGATOR
References: