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Hip ArthroscopyNCT02882633

Lumbar Plexus Block vs Fascia Iliaca Block After Hip Arthroscopy

A study testing 30ml bolus of bupivacaine in people with Hip Arthroscopy and Nerve Block, run by University of Pennsylvania at 1 site in United States.

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

The purpose of this study is to compare lumbar plexus block to fascia iliac block done in adult patients who have undergone hip arthroscopy surgery. Visual analogue scores, opioid consumption, and quality of recovery 48 hours post operatively will be used for comparison. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hip Arthroscopy, Nerve Block
What is being tested?
30ml bolus of bupivacaine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteUnited States
Study dates
Nov 2015to May 2018
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult patients18 years and older scheduled for hip arthroscopy surgery
  • American Society of Anesthesiologists (ASA) physical status I -III
  • Mentally competent and able to give consent for enrollment in the study

Who cannot join

  • Chronic opioid use (use of any opioid daily or on most days of the week for more than 3 months)
  • Diagnosed peripheral neuropathy in the surgical lower extremity
  • Allergy to study medications
  • BMI >42

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Lumbar Plexus Block vs Fascia Iliaca Block After Hip Arthroscopy: A Non-inferiority Study

The purpose of this study is to compare lumbar plexus block to fascia iliac block done in adult patients who have undergone hip arthroscopy surgery. Visual analogue scores, opioid consumption, and quality of recovery 48 hours post operatively will be used for comparison.

Read the detailed description

If the patient is willing to participate and signs the consent, he/she will be randomized to one of the two treatment groups:

  1. Lumbar Plexus Block
  2. Fascia Iliaca Block

The patient will undergo general anesthesia as by the attending anesthesiologist assigned to the case. No intraoperative restrictions will be required for this study. Once in the PACU, the patient will be assessed and if their pain score is ≥ 4 on the NRS, the patient will be randomized to a lumbar plexus block or fascia iliaca block.

Patients will be monitored during block performance with standard ASA monitors. All patients will receive 2 L of oxygen via a nasal cannula. Sedatives will be titrated to effect. Midazolam 1-2 mg, and fentanyl 50-100 mcg will be used for sedation.

The fascia iliaca block will be performed in a standard fashion as described2. The patient will be placed in a supine position. The ipsilateral groin will be prepped and cleaned with chlorhexidine. An ultrasound machine with a linear transducer covered with a sterile tegaderm will be utilized. The transducer is placed inferior to the inguinal ligament until the femoral artery is located. The probe is then moved laterally until the Sartorius muscle is seen. A skin wheal with 3ml of 1% lidocaine is made and a 2-inch blunt tip needle is inserted in plane. The needle is seen to pierce the fascia iliaca and 1-2 ml of 0.25% Preservative Free bupivacaine with 1:200,000 epinephrine is injected to confirm correct needle placement between the fascia iliaca and iliopsoas muscle. An injection will be deemed adequate if local anesthetic is seen to separate these two layers in a medial to lateral direction. A total of 30ml of the above solution will be injected.

The lumbar plexus block will be performed with the patient placed in a lateral position with the operative side facing up. An ultrasound machine with a curved transducer covered with a sterile tegaderm will be utilized. The ipsilateral hip and knee will be flexed to 90 degrees. The anatomy for the LP block will be localized using a modified transverse scan of the lumbar paravertebral area (PMTS). This technique is well described by Karmarkar et al.7 The target vertebral level will be identified by locating the lumbosacral junction (the gap of L5-S1) using a paramedian sagittal scan and then counting cranially to locate both the lamina and the transverse process of L3-L5. The transducer is then placed 4 cm lateral to the midline at the L3-4 level and directed medially to insonate the intervertebral foramen through the lumbar intervertebral space. A skin wheal is made at this site with 1% lidocaine. and a 4 inch blunt tip needle is introduced 4 cm lateral to the midline and just medial of the transducer after connecting it to a nerve stimulator set at 1.00 mA. The needle is slowly advanced under ultrasound guidance until engaged in the psoas compartment and a quadriceps twitch is elicited. The nerve stimulator is turned down until the twitch is abolished at 0.3mA or less. 1-2cmlof 0.25% Preservative free Bupivacaine with 1:200,000 epinephrine is injected slowly after negative aspiration. A total of 30ml will be injected. Spread will be confirmed with ultrasound.

All patients will receive prophylaxis for postoperative nausea and vomiting (PONV) during surgery. The protocol for prophylaxis against PONV includes administration of 4 mg of dexamethasone after induction of anesthesia and 4 mg of ondansetron 20 minutes before recovery from anesthesia. Dexamethasone is withheld if the patient has poorly controlled diabetes mellitus (DM). Uncontrolled DM will be defined as random blood glucose above 250 mg/dl.

Being tested
30ml bolus of bupivacaine
Keywords
lumbar plexus block, fascia iliac block, quality of recovery score, pain score

What participants receive

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

  • 30ml bolus of bupivacaineDrug

    Also called Marcaine, Sensorcaine

    Local anesthetic

Study groups in NCT02882633
Study groupRoleWhat they receive
Lumbar Plexus BlockActive comparatorSubjects will receive single shot local anesthetic, 30 ml bolus of bupivacaine, given preoperatively to help with postoperative pain
Receives: Drug: 30ml bolus of bupivacaine
Fascia Iliac BlockActive comparatorSubjects will receive single shot local anesthetic, 30 ml bolus of bupivacaine, given preoperatively to help with postoperative pain
Receives: Drug: 30ml bolus of bupivacaine

What is being measured

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

  1. Pain Score Change

    Change in pain scores, as measured by the Visual Analog Scale (0-10). 10 is worst imaginable pain and 0 means no pain at all.

    Measured: Change from baseline through 15 minutes

  2. Amount of Opiate Consumption

    Participants need for pain relief as measured by opiate consumption

    Measured: While in PACU. An average length of stay for Lumbar Plexus Block group was 165.04 min and 139.72 min for Fascia Iliaca Block group.

Secondary outcomes (1)
  1. Quality of Recovery

    Score of QoR survey to determine recovery status. 0-18 where 0 is the worst and 18 is the best feeling.

    Measured: Change from baseline through 24 hours

Timeline

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

  1. First posted30 Aug 2016 (estimated)
  2. Study startNov 2015
  3. Primary completionMay 2018
  4. Study completionMay 2018

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
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02882633
Sponsor's protocol ID
822547Upenn
Status last verified
May 2019
First submitted
16 Aug 2016
Last updated
11 Jun 2019
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing 30ml bolus of bupivacaine in people with Hip Arthroscopy and Nerve Block, run by University of Pennsylvania at 1 site in United States.

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 3 inclusion and 4 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 11 Jun 2019. 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 United States. 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?

Yes. Results are posted in the registry (first posted 11 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Pain Score Change (time frame: Change from baseline through 15 minutes). The study lists 2 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 11 Jun 2019.

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