Peripheral Nerve Block vs Spinal Anesthesia in Hip Surgery

NCT04506450 | Completed

• 1 other identifier: 721
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Hip Arthroplasty

Keywords

Regional anesthesia; Hip arthroplasty; Nerve block; Lumbar plexus block

Outcome Measures

Primary Outcomes (4)

• Change of the systolic blood pressure

  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

  During anesthetic and surgery procedures

• Change of the diastolic blood pressure

  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

  During anesthetic and surgery procedures

• Change of the mean blood pressure

  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

  During anesthetic and surgery procedures

• Change of the heart rate

  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

  During anesthetic and surgery procedures

Secondary Outcomes (15)

• Change in the onset time of the nerve block

  Up to 20 minutes

• Change in the degree of the sensory block

  Up to 20 minutes after the end of the anesthetic procedure

• Change of the Motor block degree

  Up to 20 minutes after the end of the anesthetic procedure

• Amount ephedrine administered during the perioperative period

  During anesthetic and surgery procedures

• Amount atrophine administered during the perioperative period

  During anesthetic and surgery procedures

Study Arms (2)

Peripheral nerve block

ACTIVE COMPARATOR

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

Procedure: Peripheral nerve block

Spinal anesthesia

ACTIVE COMPARATOR

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

Procedure: Spinal anesthesia

Interventions

Peripheral nerve block PROCEDURE

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.

Peripheral nerve block

Spinal anesthesia PROCEDURE

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.

Spinal anesthesia

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Università Politecnica delle Marche: lead

Study Sites (1)

Ospedali Riuniti di Ancona - Università politecnica delle marche

Ancona, 60126, Italy

Location

MeSH Terms

Interventions

Anesthesia, Spinal

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Diego Tavoletti, MD

  Ospedali riuniti di Ancona-Università politecnica delle Marche

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 6, 2020
• First Posted: August 10, 2020
• Study Start: January 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: August 10, 2020

Record last verified: 2020-08

Locations

IT (1)