NCT04506450

Peripheral Nerve Block vs Spinal Anesthesia in Hip Surgery

Peripheral Nerve Block vs Spinal Anesthesia in Hip Surgery: a Randomized Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Università Politecnica delle Marche · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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

Conditions

• Hip Arthroplasty

Interventions

Type	Name	Description
PROCEDURE	Peripheral nerve block	In this group, four nerve blocks will be associated to ensure adequate anesthesia and analgesia during hip surgery. Lumbar plexus and sciatic nerve blocks will be performed with a needle connected to an electrical nerve stimulation. The needle will be advanced until contraction of the femoral quadriceps muscle and plantar or dorsal flexion of the foot will be detected respectively. For both, a mixture of mepivacaine and levobupivacaine will be injected. Lateral femoral cutaneous nerve block will be performed with the ultrasound technique. After identifying the nerve, a needle will be inserted with an "in plane" approach and will be injected. Lateral branch of iliohypogastric nerve block will be executed with the "De Visme approach". Along the iliac crest (range between 7 and 11 cm from the anterior superior iliac spine) a needle will be inserted until bone contact is found. Then a mixture of mepivacaine and levobupivacaine will be injected.
PROCEDURE	Spinal anesthesia	In this group, spinal anesthesia will be performed to ensure anesthesia during surgery, while lumbar plexus block will be performed to ensure postoperative analgesia Spinal anesthesia will be performed with a 25 G needle and 12 mg 0.5% levobupivacaine will be injected. Lumbar plexus block will be performed with a needle connected to an electrical nerve stimulation. The needle will be advanced until contraction of the femoral quadriceps muscle will be detected. 20 ml 0.5% levobupivacaine will be injected.

Timeline

• Start date: 2019-01-01
• Primary completion: 2019-12-01
• Completion: 2019-12-01
• First posted: 2020-08-10
• Last updated: 2020-08-10

Locations

1 site across 1 country: Italy