Peripheral Nerve Block vs Spinal Anesthesia in Hip Surgery: a Randomized Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Change of the systolic blood pressure
Study Overview
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Change of the systolic blood pressure
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
- Degree of patient satisfaction(At the end of surgery)
- Amount of analgesic drugs administered(1, 3, 6, 12, 24, 36, 48 hours after the end of surgery)
- Change in the degree of the sensory block(Up to 20 minutes after the end of the anesthetic procedure)
- Amount atrophine administered during the perioperative period(During anesthetic and surgery procedures)
- Amount Fluids administered during the perioperative period(During anesthetic and surgery procedures)
- Amount ephedrine administered during the perioperative period(During anesthetic and surgery procedures)
- Duration of surgery(During surgery)
- Postoperative pain score(1, 3, 6, 12, 24, 36, 48 hours after the end of surgery)
- 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.)
- Change in the onset time of the nerve block(Up to 20 minutes)
- Change of the Motor block degree(Up to 20 minutes after the end of the anesthetic procedure)
- Clinical complications(Immediately after the surgery)
- Duration of hospitalization(Up to one month)
- Beginning of physical rehabilitation(Immediately after the surgery)
- Anesthetic and surgery complications(During anesthetic and surgery procedures)
Investigators
Diego Tavoletti
Principal Investigator
Università Politecnica delle Marche