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Hip FracturesNCT03885739

Continuous Pericapsular Nerve Group Block in Hip Fracture Patients

A study testing Continuous Pericapsular Nerve Group block in people with Hip Fractures, run by Adriana Margarita Cadavid at 1 site in Colombia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Background- Despite clinical guidelines favoring surgical repair of hip fracture (HF) within 48 hours of injury, patients may wait considerable periods of time for their turn in the operating room. In this context, continuous nerve blocks are an attractive alternative for pain management. Read more about this study

Who is it for?
Ages 18 to 95 years
Conditions the study is for
Hip Fractures
What is being tested?
Continuous Pericapsular Nerve Group block
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteColombia
Study dates
1 Oct 2018to 15 Jan 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 95 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults
  • Acute hip fractures
  • Severe pain
  • Patients, or their legal representatives, provided written informed consent for procedure.

Who cannot join

  • Women in pregnancy
  • Trauma score greater than or equal to 16
  • Incomplete data

Trial locations and contacts

1 site in 1 country.

Colombia1 site
  • hospital universitario San Vicente Fundacion

    Medellín, Antioquia

Other trials in Colombia

About this study

Background- Despite clinical guidelines favoring surgical repair of hip fracture (HF) within 48 hours of injury, patients may wait considerable periods of time for their turn in the operating room. In this context, continuous nerve blocks are an attractive alternative for pain management. However, the ideal block technique is not yet defined. Recently a new ultrasound-guided approach for selective blockade of the articular branches to the hip, the PENG (Pericapsular Nerve Group) block, has been proposed with potentials advantages for perioperative hip fracture analgesia.

Objective- To describe the analgesic efficacy and feasibility of continuous Pericapsular Nerve Group block (CPENGB) in patients with HF.

Design-Interventional study. Setting-Academic Level 3 center. Methods- Two experienced anesthesiologist completed 15 sonographically guided Pericapsular Nerve Group (PENG) injections and catheter insertion in patients with severe pain awaiting HF surgery. Each injection consisted of 20 mL of local anesthetics followed by a 0.1% bupivacaine continuous infusion at a constant rate of 8 ml per hour. Pain at rest and on 15° leg lift of the fractured leg were assessed before procedure, 10 and 30 minutes after block performance, and each 24 hours until surgery. A reduction of severe or moderate dynamic pain to mild pain or no pain, and a pain relief of 2 (moderate) were clinically significant findings. To determine feasibility time and number of attempts to perform the procedure were measured.

Read the detailed description

Methods: 15 sonography-guided PENG injections and catheter placement were performed in consecutive HF patients who were admitted to a single level 3 center and who report severe pain despite a standardized analgesia protocol. Patients were assessed by the Pain Service as part of a multidisciplinary care pathway and CPENGB was offered as a component of a multimodal analgesic regimen. All patients, or their legal representatives, provided written informed consent for procedure. Demographic and clinical characteristics were reviewed. To determine feasibility, time to perform the procedure was recorded, number of attempts and complications. To assess pain control, patient reported pain scores were used and the amount of morphine intravenous equivalent consumption (MIVEC) before and after block. Patients were asked to rate the severity of their pain on a 4-point numeric rating scale (Verbal Rating Scale with four response categories, VRS-4): 1) no pain, 2) mild pain, 3) moderate pain, and 4) severe pain or ''worst pain imaginable''. Pain at rest and on movement (pain on 15° leg lift of the fractured leg) were evaluated at baseline and at different times after procedure (10 minutes, 30 minutes, 24 hours and 48 hours after procedure) while the catheter was in situ. Pain relief [PR, 0 (none), 1 (slight), 2 (moderate), 3 (lots), 4 (complete)] was recorded at 30 minutes after procedure. A reduction of severe dynamic pain to mild pain or no pain, according to verbal report of patients, and a pain relief of 2 (moderate) were clinically significant findings. Type of fracture (extra or intracapsular), periprocedural complications, the presence of analgesic-related adverse effects and bromage score (30 minutes after catheter placement and each 24 hours during routine medical round) were also recorded. Complications were assessed until first orthopedic review (at 3-6 week postoperative). Procedure: All procedures were performed by two anesthesiology co-investigators who had more that 5 years of experience performing regional techniques in clinical practice and who underwent one prior training PENG blocks to standardize the approach. Injections were performed using a curvilinear low-frequency ultrasound probe (3.5- to 5-MHz). The lateral border of iliopsoas tendon in an oblique axial plane at level of iliopectineal eminence provides target for needle placement. Toggling the transducer was necessary to optimize visualization of the iliopsoas tendon secondary to anisotropy. Injections were performed using an 18-gauge Tuohy needle under sterile conditions. Following negative aspiration, a test injection was performed using 10 ml 1% lidocaine in 3-mL increments while observing in real time for ensure adequate peritendinous fluid spread of local anesthesia. Then, 10 mL 0.25% bupivacaine was administered and a 20-G polyamide catheter (connect to a filter) was advanced into the space. The end point of the catheter placement was the direct visualization of microbubbles in a peritendinous distribution using a bolus of agitated saline applied through threaded catheter connected to not purged filter. After catheter placement patients received a 0.1% bupivacaine continuous infusion at a constant rate of 8 ml per hour. If needed per anesthesiologist discretion, rescue bolus was administrated and continuous infusion rate was increased until adequate analgesia was noted. In addition, patients received a standardized analgesia protocol (preoperatively and later in the ward) consisting of 1 g paracetamol orally 2-3 times a day and opioid rescue analgesia as needed if pain moderate or severe was reported (0.05-0.1 mg/kg of intravenous morphine, or hydromorphone or tramadol equivalent, 4-6 times a day). Patients in who there were other possible causes of pain (per example: multiples traumatic lesions) received an opioid regimen by schedule plus rescue doses or intravenous patient-controlled analgesia under standardized protocols.

Conditions
Hip Fractures
Being tested
Continuous Pericapsular Nerve Group block
Medical subject headings
Hip Fractures

What participants receive

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

  • Continuous Pericapsular Nerve Group blockOther

    Continuous Pericapsular Nerve Group block to standardize the approach. Injections were performed using a curvilinear low-frequency ultrasound probe (3.5- to 5-MHz). The lateral border of iliopsoas tendon in an oblique axial plane at level of iliopectineal eminence provides target for needle placement. Toggling the transducer was necessary to optimize visualization of the iliopsoas tendon secondary to anisotropy. Injections were performed using an 18-gauge Tuohy needle under sterile conditions. Then, 10 mL 0.25% bupivacaine was administered and a 20-G polyamide catheter (connect to a filter) was advanced into the space. The end point of the catheter placement was the direct visualization of microbubbles in a peritendinous distribution using a bolus of agitated saline applied through threaded catheter connected to not purged filter. After catheter placement patients received a 0.1% bupivacaine continuous infusion at a constant rate.

Study groups in NCT03885739
Study groupRoleWhat they receive
Patients with hip fractureOther15 consecutive HF patients who were admitted to a single level 3 center and who report severe pain despite a standardized analgesia protocol. Patients were assessed by the Pain Service as part of a multidisciplinary care pathway and a Continuous Pericapsular Nerve Group blocks was offered as a component of a multimodal analgesic regimen.
Receives: Other: Continuous Pericapsular Nerve Group block

What is being measured

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

  1. Verbal Rating Scale with four response categories, VRS-4

    Patients were asked to rate the severity of their pain on a 4-point numeric rating scale VRS-4: 1) no pain, 2) mild pain, 3) moderate pain, and 4) severe pain or ''worst pain imaginable''. Pain at rest and on movement (pain on 15° leg lift of the fractured leg)

    Measured: Before procedure

  2. Verbal Rating Scale with four response categories, VRS-4

    Patients were asked to rate the severity of their pain on a 4-point numeric rating scale VRS-4: 1) no pain, 2) mild pain, 3) moderate pain, and 4) severe pain or ''worst pain imaginable''. Pain at rest and on movement (pain on 15° leg lift of the fractured leg)

    Measured: 10 minutes after procedure

  3. Verbal Rating Scale with four response categories, VRS-4

    Patients were asked to rate the severity of their pain on a 4-point numeric rating scale VRS-4: 1) no pain, 2) mild pain, 3) moderate pain, and 4) severe pain or ''worst pain imaginable''. Pain at rest and on movement (pain on 15° leg lift of the fractured leg)

    Measured: 30 minutes after procedure

  4. Verbal Rating Scale with four response categories, VRS-4

    Patients were asked to rate the severity of their pain on a 4-point numeric rating scale VRS-4: 1) no pain, 2) mild pain, 3) moderate pain, and 4) severe pain or ''worst pain imaginable''. Pain at rest and on movement (pain on 15° leg lift of the fractured leg)

    Measured: 24 hours after procedure

  5. Verbal Rating Scale with four response categories, VRS-4

    Patients were asked to rate the severity of their pain on a 4-point numeric rating scale VRS-4: 1) no pain, 2) mild pain, 3) moderate pain, and 4) severe pain or ''worst pain imaginable''. Pain at rest and on movement (pain on 15° leg lift of the fractured leg)

    Measured: 48 hours after procedure

Timeline

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

  1. First posted22 Mar 2019
  2. Study start1 Oct 2018
  3. Primary completion15 Jan 2019
  4. Study completion15 Jan 2019

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
Not applicable
Intervention model
Single group
Model description
interventional study.
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03885739
Sponsor's protocol ID
UdeA1004
Status last verified
May 2023
First submitted
27 Feb 2019
Last updated
15 May 2023
Results posted
No
Data monitoring committee
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 Continuous Pericapsular Nerve Group block in people with Hip Fractures, run by Adriana Margarita Cadavid at 1 site in Colombia.

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 3 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 15 May 2023. 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 Colombia. 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?

Verbal Rating Scale with four response categories, VRS-4 (time frame: Before procedure). The study lists 5 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 15 May 2023; AzTrials last refreshed its copy on 6 Nov 2026.

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