Hip ArthroplastyNCT04506450
Peripheral Nerve Block vs Spinal Anesthesia in Hip Surgery
A study testing Peripheral nerve block and Spinal anesthesia in people with Hip Arthroplasty, run by Università Politecnica delle Marche at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Hip Arthroplasty
- What is being tested?
- Peripheral nerve block and Spinal anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2019to 1 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Italy1 site
Ospedali Riuniti di Ancona - Università politecnica delle marche
Ancona, 60126
About this study
Official title: Peripheral Nerve Block vs Spinal Anesthesia in Hip Surgery: a Randomized Study
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.
Read more
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
Read the 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
- Being tested
- Peripheral nerve block, Spinal anesthesia
- Keywords
- Regional anesthesia, Hip arthroplasty, Nerve block, Lumbar plexus block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral nerve blockProcedure or surgery
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 anesthesiaProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Peripheral nerve block |
| Spinal anesthesia | Active comparator | The participant will receive a combination of spinal anesthesia and lumbar plexus block Receives: Procedure: Spinal anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: During anesthetic and surgery procedures
Secondary outcomes (15)
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
Measured: Up to 20 minutes
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
Measured: Up to 20 minutes after the end of the anesthetic procedure
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.
Measured: Up to 20 minutes after the end of the anesthetic procedure
Amount ephedrine administered during the perioperative period
Ephedrine use, mg.
Measured: During anesthetic and surgery procedures
Amount atrophine administered during the perioperative period
Atropine use, mg.
Measured: During anesthetic and surgery procedures
Amount Fluids administered during the perioperative period
All fluids administered, ml.
Measured: During anesthetic and surgery procedures
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)
Measured: At the end of surgery
Duration of surgery
minutes
Measured: During surgery
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")
Measured: 1, 3, 6, 12, 24, 36, 48 hours after the end of surgery
Amount of analgesic drugs administered
Paracetamol use, mg; Morphine use, mg; Ketorolac use, mg.
Measured: 1, 3, 6, 12, 24, 36, 48 hours after the end of surgery
Assessment of mental state
It will be evaluated through the mini mental state evaluation
Measured: 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.
Beginning of physical rehabilitation
number of day
Measured: Immediately after the surgery
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
Measured: During anesthetic and surgery procedures
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
Measured: Immediately after the surgery
Duration of hospitalization
Duration (day) of hospital stay
Measured: Up to one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2020
- Study start1 Jan 2019
- Primary completion1 Dec 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università Politecnica delle Marche
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diego Tavoletti, Università Politecnica delle Marche
- Investigators
- Diego Tavoletti, MD, Principal investigator, Ospedali riuniti di Ancona-Università politecnica delle Marche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04506450
- Sponsor's protocol ID
- 721
- Status last verified
- Aug 2020
- First submitted
- 6 Aug 2020
- Last updated
- 10 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripheral Nerve Block vs Spinal Anesthesia in Hip Surgery: a Randomized Study
- ClinicalTrials.gov ID
- NCT04506450
- Acronym / sponsor ID
- 721
- Conditions
- Hip Arthroplasty
- Keywords
- Regional anesthesia, Hip arthroplasty, Nerve block, Lumbar plexus block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Università Politecnica delle MarcheUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 10 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peripheral nerve block | Active comparator | Procedure: Peripheral nerve blockThe participant will receive a combination of lumbar plexus block, sciatic nerve block, lateral femoral cutaneous nerve block and lateral branch of iliohypogastric nerve block |
| Spinal anesthesia | Active comparator | Procedure: Spinal anesthesiaThe participant will receive a combination of spinal anesthesia and lumbar plexus block |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- Subject inability to provide adequate informed consent
- Study refusal
- Age younger than 18 years
- Contraindication to regional anesthesia
- Allergy to local anesthetics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peripheral nerve blockIn 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 or surgery | Peripheral nerve block |
| Spinal anesthesiaIn 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. | Procedure or surgery | Spinal anesthesia |
Primary outcome
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
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
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
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
15 secondary outcomes
Change in the onset time of the nerve block
Time frame: Up to 20 minutes
Change in the degree of the sensory block
Time frame: Up to 20 minutes after the end of the anesthetic procedure
Change of the Motor block degree
Time frame: Up to 20 minutes after the end of the anesthetic procedure
Amount ephedrine administered during the perioperative period
Time frame: During anesthetic and surgery procedures
Amount atrophine administered during the perioperative period
Time frame: During anesthetic and surgery procedures
Amount Fluids administered during the perioperative period
Time frame: During anesthetic and surgery procedures
Degree of patient satisfaction
Time frame: At the end of surgery
Duration of surgery
Time frame: During surgery
Postoperative pain score
Time frame: 1, 3, 6, 12, 24, 36, 48 hours after the end of surgery
Amount of analgesic drugs administered
Time frame: 1, 3, 6, 12, 24, 36, 48 hours after the end of surgery
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.
Beginning of physical rehabilitation
Time frame: Immediately after the surgery
Anesthetic and surgery complications
Time frame: During anesthetic and surgery procedures
Clinical complications
Time frame: Immediately after the surgery
Duration of hospitalization
Time frame: Up to one month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diego Tavoletti, MD principal investigator
Ospedali riuniti di Ancona-Università politecnica delle Marche
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peripheral nerve block and Spinal anesthesia in people with Hip Arthroplasty, run by Università Politecnica delle Marche at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of the systolic blood pressure (time frame: During anesthetic and surgery procedures). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2020; AzTrials last refreshed its copy on 29 Oct 2026.