Peripheral Nerve Block vs Spinal Anesthesia in Hip Surgery

Hip Arthroplasty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04506450
• Other study ID #: 721
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: December 1, 2019

Study information

• Verified date: August 2020
• Source: Università Politecnica delle Marche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 1, 2019
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Hip Arthroplasty

Intervention

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.
• 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.

Locations

Country	Name	City	State
Italy	Ospedali Riuniti di Ancona - Università politecnica delle marche	Ancona

Sponsors (1)

Lead Sponsor	Collaborator
Università Politecnica delle Marche

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Change in the onset time of the nerve block	Sensitivity to the lower limbs will be assessed by pinprick test and cold test after the end of the anesthetic procedure	Up to 20 minutes
Secondary	Change in the degree of the sensory block	Sensitivity to the lower limbs will be assessed by pinprick test and cold test after the end of the anesthetic procedure	Up to 20 minutes after the end of the anesthetic procedure
Secondary	Change of the Motor block degree	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.	Up to 20 minutes after the end of the anesthetic procedure
Secondary	Amount ephedrine administered during the perioperative period	Ephedrine use, mg.	During anesthetic and surgery procedures
Secondary	Amount atrophine administered during the perioperative period	Atropine use, mg.	During anesthetic and surgery procedures
Secondary	Amount Fluids administered during the perioperative period	All fluids administered, ml.	During anesthetic and surgery procedures
Secondary	Degree of patient satisfaction	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)	At the end of surgery
Secondary	Duration of surgery	minutes	During surgery
Secondary	Postoperative pain score	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")	1, 3, 6, 12, 24, 36, 48 hours after the end of surgery
Secondary	Amount of analgesic drugs administered	Paracetamol use, mg; Morphine use, mg; Ketorolac use, mg.	1, 3, 6, 12, 24, 36, 48 hours after the end of surgery
Secondary	Assessment of mental state	It will be evaluated through the mini mental state evaluation	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.
Secondary	Beginning of physical rehabilitation	number of day	Immediately after the surgery
Secondary	Anesthetic and surgery complications	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	During anesthetic and surgery procedures
Secondary	Clinical complications	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	Immediately after the surgery
Secondary	Duration of hospitalization	Duration (day) of hospital stay	Up to one month