Peripheral Nerve Block vs Spinal Anesthesia in Hip Surgery

Università Politecnica delle Marche

Status: Completed

Conditions: Hip Arthroplasty

Treatments: Procedure: Peripheral nerve block; Procedure: Spinal anesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT04506450

721

Details and patient eligibility

About

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

Full 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

Enrollment: 100 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

100 participants in 2 patient groups

Peripheral nerve block

Active Comparator group

Description:

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

Treatment:

Procedure: Peripheral nerve block

Spinal anesthesia

Active Comparator group

Description:

The participant will receive a combination of spinal anesthesia and lumbar plexus block

Treatment:

Procedure: Spinal anesthesia