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NCT Number: NCT04506450

Peripheral Nerve Block vs Spinal Anesthesia in Hip Surgery

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

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Key information

Conditions

Hip Arthroplasty

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ospedali Riuniti di Ancona - Università politecnica delle marche

Ancona, 60126, Italy

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  1. Change in the onset time of the nerve block

    Time frame: Up to 20 minutes

    Sensitivity to the lower limbs will be assessed by pinprick test and cold test after the end of the anesthetic procedure

  2. Change in the degree of the sensory block

    Time frame: Up to 20 minutes after the end of the anesthetic procedure

    Sensitivity to the lower limbs will be assessed by pinprick test and cold test after the end of the anesthetic procedure

  3. Change of the Motor block degree

    Time frame: Up to 20 minutes after the end of the anesthetic procedure

    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.

  4. Amount ephedrine administered during the perioperative period

    Time frame: During anesthetic and surgery procedures

    Ephedrine use, mg.

  5. Amount atrophine administered during the perioperative period

    Time frame: During anesthetic and surgery procedures

    Atropine use, mg.

  6. Amount Fluids administered during the perioperative period

    Time frame: During anesthetic and surgery procedures

    All fluids administered, ml.

  7. Degree of patient satisfaction

    Time frame: At the end of surgery

    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)

  8. Duration of surgery

    Time frame: During surgery

    minutes

  9. Postoperative pain score

    Time frame: 1, 3, 6, 12, 24, 36, 48 hours after the end of surgery

    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")

  10. Amount of analgesic drugs administered

    Time frame: 1, 3, 6, 12, 24, 36, 48 hours after the end of surgery

    Paracetamol use, mg; Morphine use, mg; Ketorolac use, mg.

  11. Assessment of mental state

    Time frame: 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.

    It will be evaluated through the mini mental state evaluation

  12. Beginning of physical rehabilitation

    Time frame: Immediately after the surgery

    number of day

  13. Anesthetic and surgery complications

    Time frame: During anesthetic and surgery procedures

    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

  14. Clinical complications

    Time frame: Immediately after the surgery

    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

  15. Duration of hospitalization

    Time frame: Up to one month

    Duration (day) of hospital stay

Sponsors and collaborators

Lead sponsor

Università Politecnica delle Marche

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Aug 10, 2020
Registry last updated
Aug 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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