Ignite Creation Date:
2025-12-24 @ 5:21 PM
Ignite Modification Date:
2025-12-24 @ 5:21 PM
Study NCT ID:
NCT04506450
Status:
COMPLETED
Last Update Posted:
2020-08-10
First Post:
2020-08-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Peripheral Nerve Block vs Spinal Anesthesia in Hip Surgery
Sponsor:
Università Politecnica delle Marche
Organization:
Study Overview
Official Title:
Peripheral Nerve Block vs Spinal Anesthesia in Hip Surgery: a Randomized Study
Status:
COMPLETED
Status Verified Date:
2020-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: