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Pertrochanteric FractureNCT05079087

Pericapsular Nerve Group Block for Positional Pain and Postoperative Analgesia in Hip Fractures

A study testing Pericapsular nerve group blockade and Midazolam Ketamine arm in people with Pertrochanteric Fracture and Pain, Postoperative, run by Azienda Sanitaria dell'Alto Adige at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The aims of this study are: Evaluate the effectiveness of the pericapsulare blockade of the femoral nerve, the accessory obturator nerve and the obturator nerve in patients with pertrochanteric fractures of the femur, during the pre-operative period for patient positioning manoeuvres (sitting position for performing… Read more about this study

Who is it for?
Any age
Conditions the study is for
Pertrochanteric Fracture, Pain, Postoperative
What is being tested?
Pericapsular nerve group blockade and Midazolam Ketamine arm
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 Apr 2021to 1 Nov 2022
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Patients with a peritrocanteric femur fracture admitted to the orthopaedic ward

Who cannot join

  • Patient refusal
  • Lack of informed consent
  • Pathological skin alterations
  • Intertrigo at the puncture site level.
  • Allergy to any of the drugs
  • Coagulopathy
  • Sepsis
  • Use of direct oral anticoagulatns (DOACs)

Trial locations and contacts

1 site in 1 country.

Italy1 site, 1 recruiting
  • Azienda sanitaria Allo Adige ospedale di Merano

    Meran, Bolzano, 39012

    PAOLO SERAGLIO, MD, 00390473267570, paolomarioenrico.seraglio@sabes.it

    Ivo Regli, MD PhD

    Recruiting

Other trials in Italy

About this study

Official title: Pericapsular Nerve Group Block for Positional Pain and Postoperative Analgesia

The aims of this study are:

  • Evaluate the effectiveness of the pericapsulare blockade of the femoral nerve, the accessory obturator nerve and the obturator nerve in patients with pertrochanteric fractures of the femur, during the pre-operative period for patient positioning manoeuvres (sitting position for performing spinal anaesthesia, mobilisation on the operating bed, etc.);
  • Evaluate the consumption of opioids or hypnotics in the perioperative period, which are more responsible for the incidence of delirium in the elderly patient;
  • Evaluate the duration and quality of postoperative analgesia and well-being.
Read the detailed description

Pertrochanteric femoral fracture is a frequent orthopaedic emergency in the elderly and is associated with significant morbidity and mortality. Surgical reduction and subsequent fixation is the definitive therapy for most patients. Recent clinical studies show that early treatment within the first 48 hours significantly reduced mortality and major complication (pulmonary embolism, sepsis, cardiac events, renal and respiratory failure). Even though, data regarding the anaesthesiology method best suited for this intervention are somewhat controversialthe Italian Society for Anaesthesiology, Analgesia Reanimation and intensive care recommends spinal anaesthesia as the standard procedure. In addition, the Association of Anaesthetists of Great Britain and Ireland recommend this approach.

Patient mobilisation for the administration of spinal anaesthesia as well as post-operative care require effective perioperative pain management. In current practice, this is achieved by the administration of systemic analgosedative treatment. Ideally, the use of opioids or ketamine should be minimized since their side effects are major morbidity factors. Peripheral nerve blocked can be an efficient to foster pre- and postoperative analgesia and therefore minimize the need for opioids.

Currently, the psoas compartment block is considered to be the most reliable peripheral nerve block for analgesia in pertrochanteric femoral fractures, although it is technically rather difficult to perform and could be associated with serious side effects. Alternative approaches, such as the femoral nerve block, the Iata band block or the 3-in-1 block often do not possess a sufficient reliable analgesic effect in this kind of injury. Thus so far, peripheral nerve blocks are not routinely applied in clinical practice in most cases.

The anterior capsule of the hip joint is the most innervated area of the entire joint.

The nerves involved are:

  • The obturatorial nerve
  • The accessory nerve of the obturator
  • The femoral nerve Adequate anaesthesia for pertrochanteric femoral facture requires the blockage of all three nerves. In 2018, Gíron-Arango et al., developed a novel ultrasound guided approach for the blockade these nerves, the Pericapsular nerve group (PENG) block. The investigators consider this peripheral nerve block a potentially beneficial technique to implement in the treatment of per trochanteric femur fracture patients.

Patients with a pertochanteric femoral fracture admitted to the orthopaedics department for surgical treatment will be asked whether they are willing to participate to the study. After transfer of the patient to Anaesthesiology, before performing any additional analgesic measures, the NRS at rest and on the movement of the affected limb (extension of 20°) will be evaluated. The 4AT test for the assessment of delirium will be performed to obtain a baseline value. The participants will be randomly assigned to two groups. Due to the fact that these patients need swift treatment for their injury, our randomisation is based on alternating assignments to the two groups based on the time patients sign their informed consent for study participation. The investigators have no indication that this randomisation procedure could lead to a bias. The first group will consist of patients that undergo PENG block administering a mixture of Ropivacaine 0.5% + Dexamethasone 4 mg in a volume of 20 ml before performing the spinal anaesthesia. There is one report indicating that a 1:1 mixture of ropivacaine 0.75% with 4mg/mL dexamethasone could pose a risk due to crystal formation. However, in our clinical practice, where the investigators mix 0.5% in a 1:20 ratio, thus producing an injection containing 30-times less dexamethasone, the investigators did never experience problems with crystallisation. This is extensively backed by literature. In any case, the patients will be informed about the off-label nature of perineural dexamethasone during the anaesthesiologic visit.

The PENG-block will be administered under ultrasound (US) guidance with a low frequency curvilinear probe. The probe will be placed parallel to the inguinal crease at the level of the anterior superior iliac spine. Scanning will be done with gradual caudal movement of the probe. After the anterior inferior iliac spine (AIIS) is visible, the probe will be turned slightly medial until the hyperechoic continuous shadow of the superior pubic ramus is visible. The Psoas muscle with its prominent tendon will be identified just above the pubic ramus. The target is the plane between the 2 structures. While aligning the pubic ramus in the center of the image and targeting the pubic ramus just medial to the AIIS, a 22 Go 10 cm needle will be introduced and 20 ml of anesthetic solution administered. The participants are informed about the specifics of the PENG blocks and the risks (which are minor) during the anesthesiologic visit.

Patients in the second group will undergo sedation and analgesic treatment with Ketamine and Midazolam titrated to the best Verbal Rating Score without respiratory and cardiovascular depressant effect. 30 minutes after the PENG block or the drug treatment, immediately before mobilization for the spinal anaesthesia, the assessment of NRS at rest and on movement of the affected limb (extension of 20°) will be repeated.

Spinal anaesthesia will be performed using 2.5mL isobaric bupivacaine 0.5% applying state of the art care.

After surgical intervention in postoperative care, patients do not receive fix systemic analgesia as post-operative pain should be covered by the PENG block. However, in the post-operative are they will receive Paracetamol, Metamizole and Buprenorphine if necessary. Once they are transferred to the orthopaedics department, patients analgesia will be managed according to the orthopaedics department standardized protocols. In any case, post-operative opiate consumption will be recorded. To assess post-operative pain management performance in the two groups, the NRS at rest and on movement of the affected limb (extension of 20°) will be evaluated 18 hours after the PENG block. In order to avoid too much discomfort for the patients and to not induce unnecessary inflammation in the surgical area, the investigators refrain of doing too many measurements. The investigators expect that the the 18 hours measurement together with the evaluation of post-operative opiate use will give us a clear image of post-operative pain control. Also, 18 hours after, the 4AT test will be performed to quantify symptoms of delirium. Furthermore, the occurrence of PONV and patient satisfaction on a VAS-Scale will be evaluated.

The primary endpoint is the NRS variations during movement of the affected limp (extension of 20°) before and 30 minutes as well as 18 hours after performing the PENG block or analgosedation. Secondary endpoints are occurrence of delirium quantified by the 4AT test, if and who much and which rescue opiate was used, occurrence of PONV and patient satisfaction expressed on a VAS-Scale.

Being tested
Pericapsular nerve group blockade, Midazolam Ketamine arm
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pericapsular nerve group blockadeProcedure or surgery

    Also called PENG block

    The PENG-block will be administered under ultrasound (US) guidance with a low frequency curvilinear probe. The probe will be placed parallel to the inguinal crease at the level of the anterior superior iliac spine. Scanning will be done with gradual caudal movement of the probe. After the anterior inferior iliac spine (AIIS) is visible, the probe will be turned slightly medial until the hyperechoic continuous shadow of the superior pubic ramus is visible. The Psoas muscle with its prominent tendon will be identified just above the pubic ramus. The target is the plane between the 2 structures. While aligning the pubic ramus in the center of the image and targeting the pubic ramus just medial to the AIIS, a 22 Go 10 cm needle will be introduced and 20 ml of anesthetic solution administered.

  • Midazolam Ketamine armDrug

    Also called Analgosedation treatment

    Patients in the second group will undergo sedation and analgesic treatment with Ketamine and Midazolam titrated to the best Verbal Rating Score without respiratory and cardiovascular depressant effect.

Study groups in NCT05079087
Study groupRoleWhat they receive
PENG BLOCK armExperimentalThe first arm will consist of patients that undergo PENG block administering a mixture of Ropivacaine 0.5% + Dexamethasone 4 mg in a volume of 20 ml before performing the spinal anaesthesia.
Receives: Procedure: Pericapsular nerve group blockade
Ketamine- Midazolam armActive comparatorThe second arm consist in Patients that will undergo sedation and analgesic treatment with Ketamine and Midazolam titrated to the best Verbal Rating Score without respiratory and cardiovascular depressant effect.
Receives: Drug: Midazolam Ketamine arm

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of the numerical rating scale for pain (NRS) during movement of the affected limb (extension of 20°) 30 minutes after the PENG block

    Measured: Change in NRS pre and 18 hours post performing the PENG block

Secondary outcomes (4)
  1. Delirium

    Change in score of the rapid assessment test for delirium screening

    Measured: Changne in score of the 4 AT rapid clinical test pre and 18 hours post performing block

  2. Rescue opiate use

    Evaluate the use of opioids in the postoperative period.

    Measured: During the first 24 hours after discharge from the recovery room

  3. PONV

    Record the occurrence of nausea or vomiting

    Measured: During the first 24 hours after discharge from the recovery room

  4. Questionnaire on patient satisfaction

    Evaluate subjective patient satisfaction

    Measured: From the beginning of the surgical procedure until 24 hours after discharge from the recovery room

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2021
  2. Study start1 Apr 2021
  3. Primary completion1 Apr 2022 (estimated)
  4. Study completion1 Nov 2022 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05079087
Sponsor's protocol ID
01
Status last verified
Oct 2021
First submitted
4 Mar 2021
Last updated
15 Oct 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Pericapsular nerve group blockade and Midazolam Ketamine arm in people with Pertrochanteric Fracture and Pain, Postoperative, run by Azienda Sanitaria dell'Alto Adige 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 1 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: status not confirmed, as of the sponsor's last update on 15 Oct 2021. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Paolo Seraglio, MD (00390473267570, paolomarioenrico.seraglio@sabes.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of the numerical rating scale for pain (NRS) during movement of the affected limb (extension of 20°) 30 minutes after the PENG block (time frame: Change in NRS pre and 18 hours post performing the PENG block). 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 15 Oct 2021.

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