Peripheral Nerve Block vs Spinal Anesthesia in Hip Surgery
- Conditions
- Hip Arthroplasty
- Interventions
- Procedure: Peripheral nerve blockProcedure: Spinal anesthesia
- Registration Number
- NCT04506450
- Lead Sponsor
- Università Politecnica delle Marche
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Peripheral nerve block Peripheral nerve block The participant will receive a combination of lumbar plexus block, sciatic nerve block, lateral femoral cutaneous nerve block and lateral branch of iliohypogastric nerve block Spinal anesthesia Spinal anesthesia The participant will receive a combination of spinal anesthesia and lumbar plexus block
- Primary Outcome Measures
Name Time Method Change of the systolic blood pressure During anesthetic and surgery procedures Systolic blood pressure will be evalueted after sedation, at the end of the anesthestic procedure, and then every 2.5 minutes up to the 20th minute. Then at the beginning of the surgery and every 5 minutes until the end of the surgery
Change of the diastolic blood pressure During anesthetic and surgery procedures Diastolic blood pressure will be evalueted after sedation, at the end of the anesthestic procedure, and then every 2.5 minutes up to the 20th minute. Then at the beginning of the surgery and every 5 minutes until the end of the surgery
Change of the mean blood pressure During anesthetic and surgery procedures Mean blood pressure will be evalueted after sedation, at the end of the anesthestic procedure, and then every 2.5 minutes up to the 20th minute. Then at the beginning of the surgery and every 5 minutes until the end of the surgery
Change of the heart rate During anesthetic and surgery procedures Heart rate will be evalueted after sedation, at the end of the anesthestic procedure, and then every 2.5 minutes up to the 20th minute. Then at the beginning of the surgery and every 5 minutes until the end of the surgery
- Secondary Outcome Measures
Name Time Method Beginning of physical rehabilitation Immediately after the surgery number of day
Degree of patient satisfaction At the end of surgery the degree of patient satisfaction will be measured on a scale ranging from 0 to 3 (0= bad; 1= not bad; 2=good; 3=excellent)
Amount of analgesic drugs administered 1, 3, 6, 12, 24, 36, 48 hours after the end of surgery Paracetamol use, mg; Morphine use, mg; Ketorolac use, mg.
Change in the degree of the sensory block Up to 20 minutes after the end of the anesthetic procedure Sensitivity to the lower limbs will be assessed by pinprick test and cold test after the end of the anesthetic procedure
Amount atrophine administered during the perioperative period During anesthetic and surgery procedures Atropine use, mg.
Amount Fluids administered during the perioperative period During anesthetic and surgery procedures All fluids administered, ml.
Duration of surgery During surgery minutes
Postoperative pain score 1, 3, 6, 12, 24, 36, 48 hours after the end of surgery 11-point numeric rating scale ranging from '0' representing one extreme (e.g. "extremely dissatisfied") to '10' representing the other extreme (e.g. "extremely satisfied")
Assessment of mental state 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. It will be evaluated through the mini mental state evaluation
Change in the onset time of the nerve block Up to 20 minutes Sensitivity to the lower limbs will be assessed by pinprick test and cold test after the end of the anesthetic procedure
Amount ephedrine administered during the perioperative period During anesthetic and surgery procedures Ephedrine use, mg.
Change of the Motor block degree Up to 20 minutes after the end of the anesthetic procedure The motor block will be assessed by the Bromage scale after the end of the anesthetic procedure. Grade 1: complete block (unable to move feet or knees). Grade 2: almost complete block (able to move feet only). Grade 3: partial block (just able to move knees). Grade 4: detectable weakness of hip flexion (between score 3 and 5). Grade 5: No detectable weakness of hip flexion while supine (full flexion of knees). Grade 6: able to perform partial knee bend.
Clinical complications Immediately after the surgery Assessment for existence of complications related to procedures in form of Y/N (such as neuropathy, nausea and vomiting, heart and vascular diseases, respiratory dysfunction, urinary retention, renal failure, cognitive disorder, death
Duration of hospitalization Up to one month Duration (day) of hospital stay
Anesthetic and surgery complications During anesthetic and surgery procedures Assessment for existence of complications related to procedures in form of Y/N (such as hypotension, bradycardia, local anesthetic epidural spread, local anesthetic systemic toxicity, nausea and vomiting
Trial Locations
- Locations (1)
Ospedali Riuniti di Ancona - Università politecnica delle marche
🇮🇹Ancona, Italy