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Hip Surgery CorrectivePhase 3NCT02717728

Effectiveness of Fascia Iliaca Nerve Block for Post Hip Arthroscopy

A Phase 3 study testing Drug group Fascia iliaca nerve block in people with Hip Surgery Corrective and Anesthesia; Functional, run by Boston Children's Hospital at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

There is currently no standard of care or best practice for managing post-operative pain for patients undergoing hip arthroscopy. Perioperative pain with these procedures can be substantial. Read more about this study

Who is it for?
Ages 12 to 35 years
What is being tested?
Drug group Fascia iliaca nerve block
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
1 siteUnited States
Study dates
Dec 2020to Dec 2021
Phase
Phase 3
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 12 to 35 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Patient age at surgery is 12-35.
  • Able to provide informed consent and/or assent.
  • Diagnosis is Femoro-acetabular impingement (FAI) and/or labral tear.
  • Surgery will involve and be limited to hip arthroscopy and osteoplasty of the acetabular rim or femoral head/neck junction.
  • Surgery will be performed by Dr. Yi-Meng Yen.
  • Admission status: 24 hour admission to hospital.
  • No contraindication to study procedures

Who cannot join

  • Hip revision surgery
  • Underlying neurologic disorder affecting pain perception.
  • Underlying neurocognitive disorder or developmental delay affecting ability to convey feelings of pain to medical staff.
  • Underlying opioid use or addiction.
  • Significant concomitant hip pathology.
  • Active infection over catheter site.
Show all 12Show fewer
  • History of chronic pain (not localized to the hip) requiring consistent opioid consumption for greater than or equal to 6 months within year prior to surgery.
  • Allergy to local anesthetics
  • Allergy to fentanyl
  • Allergy to midazolam
  • Allergy to morphine
  • American Society of Anesthesia class 3 or higher.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Boston Children's Hospital

    Boston, Massachusetts, 02115

Other trials in United States

About this study

Official title: Effectiveness of Fascia Iliaca Nerve Block for Post Hip Arthroscopy Pain Management: A Randomized Double-blind, Placebo Controlled Study

There is currently no standard of care or best practice for managing post-operative pain for patients undergoing hip arthroscopy. Perioperative pain with these procedures can be substantial. It has been shown that up to 90% of patients in the Post-anesthesia care unit (PACU) following hip arthroscopy report pain scores of 7/10. Poor pain management following hip fracture surgery directly results in increased time spent in high cost health care areas and delayed time to ambulation. Continuous regional anesthesia following hip arthroplasty has been shown to reduce narcotic consumption and related side-effects (reduction of post-operative pain, delirium, and length of stay).

The purpose of this research is to evaluate the effectiveness of a fascia iliaca nerve block in reducing post-operative pain within the first 24 hours following hip arthroscopy. Additionally, the pharmacokinetics of the drug ropivacaine will be studied via laboratory analysis of blood samples. Ultimately, the objective of this research is to develop a standard of care or best practice for the management of post-operative pain following hip arthroscopy. This study will include the entire age range of patients who are seen for hip arthroscopy at Boston Children's Hospital, for which there is a 35 year age limit. Both sexes will be included in the study.

Read more

The study design will be real catheter versus a sham catheter(control). All subjects will receive general anesthesia. The catheters (real or sham) will be administered after the induction of general anesthesia and before the beginning of the surgery until 24 hours after recorded PACU admittance time. The anesthesia team placing the block will not be blinded. The orthopaedic surgeon (Dr. Yen) and all evaluators will be blinded to the absence or presence of a real catheter. In the case of a sham catheter, the anesthesia team will rig a pump to look like it is dispensing local anesthesia.

To determine the pharmacokinetics of ropivicaine during standard fascia iliaca block, following induction of general anesthesia, a large bore IV catheter will be inserted for the purpose of blood draws (all patients).

Read the detailed description

This study will be a randomized, double-blinded, placebo controlled study. All patients who are scheduled to undergo a hip arthroscopy with Dr. Yen who meet the inclusion/exclusion criteria will be approached and informed consent and assent when indicated would be obtained.Attending surgeon, anesthesia care team, PACU nursing staff, inpatient ward nursing staff and evaluators will be blinded to study group. Regional Anesthesia team and pharmacy staff will be not blinded to assignment of patient group but will have no additional contact with patient after provision of sham or actual perineural catheter. the study design will be real catheter versus a sham catheter, or control. All subjects will receive general anesthesia. The catheters (real or sham) will be administered after the induction of general anesthesia and before the beginning of the surgery until 24 hours after recorded PACU admittance time. The anesthesia team placing the block will not be blinded. The orthopaedic surgeon (Dr. Yen) and all evaluators will be blinded to the absence or presence of a real catheter. In the case of a sham catheter, the anesthesia team will rig a pump to look like it is dispensing local anesthesia.

  1. General Anesthesia a) Induction (IV): i. propofol: 2-4 mg/kg [9] ii. fentanyl: 2 mcg/kg administered iii. decadron: 4 mg as an antiemetic b) Airway: i. Airway management will be chosen by the anesthesiologist in charge of the case.
  2. Maintenance of anesthesia i. Sevoflurane 1.1 minimum alveolar concentration (MAC) ii. If heart rate or blood pressure increase > 20% above baseline (tachycardia as determined the morning of surgery in the holding area), anesthesiologist will administer1 microgram/kg fentanyl as bolus. May repeat as often as every 10 minutes. Maximum 8 doses. iii. With patient movement, anesthesiologist will administer propofol 1 mg/kg intravenous push. May repeat every 5 minutes as necessary.
  3. Emergence i. Discontinue isoflurane ii. Zofran 4 mg IV iii. Ketorolac 0.5 mg/kg IV; max dose 30 mg.
  4. Perineural Catheter:
  • Actual and sham will be hooked to infusion pump and receptacle
  • Pharmacy will label the infusion pumps, and will cover these labels in such a way that the cover can be immediately at any point if needed.
  • Regional anesthesia team will double check the correct direction of the stopcock of the tubing set.
  1. Drug Group: i. Fascia Iliaca Catheter placement
  2. Administrator: Regional Anesthesiologist
  3. Minimum of three years anesthesia training
  4. Cannot be blinded, but will not contact/communicate with patient after surgery
  5. Appropriate laterality identified
  6. Site prepared using aseptic technique
  7. Localization of target site beneath fascia iliaca plane using portable ultrasound
  8. Aseptic preparation of probe with sterile sheath
  9. 38mm linear probe (BK Medical, USA)
  10. 15 MHz frequency
  11. Needle: 18g x 10mm echogenic enhanced needle
  12. 20G catheter inserted 3 cm beyond needle tip ii. Local anesthetic bolus <!-- -->
  13. Ropivacaine 0.5 ml/kg total in divided doses
  14. Aspirate every 5 ml
  15. Administered via needle iii. Dressing:
  16. Liquid adhesive to skin 2. Sorbaview dressing (2x2) applied directly over catheter on skin 3. Catheter coiled once on top sorbaview and clear plastic dressing applied over sorbaview 4. 3x3 gauze taped over dressing to cover insertion site 5. Catheter labeled: "Fascia Iliaca Catheter" b) Control Group i. Fascia Iliaca Catheter placement
  17. Administrator: Regional Anesthesiologist
  18. Minimum of three years anesthesia training
  19. Cannot be blinded, but will not contact/communicate with patient after surgery 2. Appropriate laterality of surgery identified 3. Site prepared using aseptic technique 4. Localization of target site beneath fascia iliaca plane using portable ultrasound
  20. Aseptic preparation of probe with sterile sheath b. 38mm linear probe (BK Medical, USA) c. 15 MHz frequency 5. 20 g catheter tip laid at appropriate insertion site ii. Dressing:
  21. Liquid adhesive to skin 2. Sorbaview dressing (2x2) applied directly over catheter on skin 3. Catheter coiled once on top sorbaview and clear plastic dressing applied over sorbaview 4. 3x3 gauze taped over dressing to hide insertion site 5. Catheter labeled: "Fascia Iliaca Catheter"
  22. Infusion
  23. Pharmacy to prepare and label all infusion syringes b) Actual content (ropivacaine 0.1%) to be covered but immediately available in case of need to know. Violation of blinding to be obvious when tubing set removed. A non-blinded member of the study team will remove the set.
  24. Drug Group: Ropivacaine 0.1% ii. Control: Ropivacaine 0.1% to plastic bag c) Device: bodyguard infusion pump d) Rate: 0.3 ml/kg/hr; max 15 to start within the first hour after the block is placed.
  25. Infusion bag to be changed out as needed by nursing staff per usual routine (depends on volume of bag, weight of patient)
  26. Surgical Procedure
  27. Hip arthroscopy performed i. Pre-operative:
  28. Patient padded, per usual method
  29. Range Of Motion check by Yen and/or surgical staff
  30. Patient placed in traction device
  31. Xrays taken (AP pelvis, Dunn, frog leg, false profile). Must get view of lesion.
  32. Leg prepped/draped in normal fashion
  33. At conclusion of surgical procedure, patients in both groups to receive standard local anesthetic infiltration i. 20 cc total
  34. 10 ml 0.2% ropivacaine intra-articular into hip joint
  35. 5 ml 0.2% ropivacaine to each trochlear site (x2) Post-operative Methods All patients will remain in the hospital for a minimum of 24 hours following surgery per Dr. Yen's normal hip arthroscopy standard of care. A blinded observer will record pain scores at 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, and 24 hours postoperatively. Pain scores will be measures at rest by an 11-point numeric rating scale (NRS) ranging from 0-10, where 0 is no pain and 10 is worst pain imaginable. All patients should complete the study and have measurements at each time point. Patient demographics including age and gender as well as surgical characteristics including length of surgery, estimated blood loss, and surgery type will be recorded. Blinded observers will also record the time until patients require additional morphine, the amount of morphine consumed at each time it was requested, and whether the patient reported nausea or experienced vomiting within the first 24 hours post-operatively.
  36. PACU a) Time 0 = PACU arrival time b) Pain scores: i. Obtained by trained, blinded nurse observers ii. Recorded per policy with minimum evaluation every 15 minutes iii. Recorded using 11 point numeric rating scale (NRS) 1. 0 = no pain; 10 = severe pain c) PCA (patient controlled analgesia) available and initiated upon arrival to PACU i. Opioid: morphine ii. Bolus dose: 0.025 mg/kg; lockout 10 minutes iii. Hourly limit: 0.15 mg/kg/hr iv. Nurse rescue bolus: 0.05 mg/kg; lockout 60 minutes 1. To be administered for NRS > 7 v. continuous hourly infusion = 0
  37. Inpatient Wards
  38. Nurses will evaluate pain per usual practice. Documented minimum every 4 hours. i. pain scores >7, nurse will administer: nurse rescue bolus via PCA ii. No dermatome test to prevent the introduction of bias by inadvertently un-blinding subjects.

Pharmacokinetic Methods To determine the pharmacokinetics of ropivicaine during standard fascia iliaca block [10-13].

  1. Following induction of general anesthesia, a large bore IV catheter will be inserted for the purpose of blood draws (all patients)
  2. Blood Sampling (all patients)
  3. Volume 2ml
  4. Time = zero defined as immediately following bolus of ropivicaine or sham equivalent
  5. First hour: collected at 5, 10, 15, 30, 35, and 60 minutes.
  6. Analysis:
  7. Internal lab
  8. Blood samples will be centrifuged to separate the plasma and stored at -20 degrees C until assay. Plasma ropivacaine levels analyzed by gas chromatography
Being tested
Drug group Fascia iliaca nerve block, Control group sham nerve block

What participants receive

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

  • Drug group Fascia iliaca nerve blockProcedure or surgery

    Device: Fascia Iliaca Catheter. Placement: Site prepared using aseptic technique.

    Device: Portable ultrasound: Localization of target site. Aseptic preparation of probe with sterile sheath. 18g x 10mm echogenic enhanced needle, 20G catheter inserted 3 cm beyond needle tip.

    Drug: Local anesthetic bolus: Ropivacaine 0.2% 0.5 ml/kg total in divided doses Device: Dressing Drug: Infusion of Ropivacaine 0.1%, rate: 0.3 ml/kg/hr; to start within the first hour after the block is placed. Infusion will be maintained for 24hs.

  • Control group sham nerve blockProcedure or surgery

    Device: Fascia Iliaca Catheter placement: Site prepared using aseptic technique.

    Device: portable ultrasound: Localization of target site. Aseptic preparation of probe with sterile sheath.

    Device: Dressing

    Drug: Infusion of Ropivacaine 0.1%, rate: 0.3 ml/kg/hr; to start within the first hour after the block is placed. Infusion will be maintained for 24hs.

Study groups in NCT02717728
Study groupRoleWhat they receive
Drug group Fascia iliaca nerve blockActive comparatorDevice: Fascia Iliaca Catheter placement Drug: Local anesthetic bolus :Ropivacaine 0.2% 0.5 ml/kg total in divided doses Device: Dressing: Catheter labeled: "Fascia Iliaca Catheter" Drug:Infusion: Ropivacaine 0.1%, rate: 0.3 ml/kg/hr; to start within the first hour after the block is placed. Infusion will be maintained for 24hs.
Receives: Procedure: Drug group Fascia iliaca nerve block
Control group sham nerve blockSham comparatorDevice: Fascia Iliaca Catheter placement (20 g catheter tip laid at appropriate insertion site) Device: Dressing: Catheter labeled: "Fascia Iliaca Catheter" Drug: Infusion: Ropivacaine 0.1% to plastic bag. rate: 0.3 ml/kg/hr; to start within the first hour after the block is placed. Infusion will be maintained for 24hs.
Receives: Procedure: Control group sham nerve block

What is being measured

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

  1. The investigators will measure morphine consumption as the endpoint, to compare the efficacy of each group

    Measured: Within the first 24hs after the fascia iliaca block is placed.

Secondary outcomes (4)
  1. The investigators will collect postoperative pain scores using the 11 point numeric rating scale in each group, to compare the efficacy of each group

    Measured: Within the first 24hs after the fascia iliaca block is placed.

  2. The investigators will collect time to first opioid consumption in each group, To compare the efficacy of each group.

    Measured: Within the first 24hs after the fascia iliaca block is placed.

  3. The investigators will document incidence of postoperative nausea and vomiting in each group.

    Measured: Within the first 24hs after the fascia iliaca block is placed.

  4. The investigators will measure maximum plasma concentrations at specific time intervals of 0.2% ropivacaine administered via a fascia iliaca block.

    Measured: Within the first hour after the fascia iliaca block is placed.

Timeline

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

  1. First posted24 Mar 2016 (estimated)
  2. Study startDec 2020 (estimated)
  3. Primary completionDec 2021 (estimated)
  4. Study completionDec 2021 (estimated)

Why it stopped: lack of funding

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 3
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02717728
Sponsor's protocol ID
IRB-P00021561
Status last verified
Jan 2022
First submitted
26 Jan 2016
Last updated
28 Jan 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Paut O, Schreiber E, Lacroix F, Meyrieux V, Simon N, Lavrut T, Camboulives J, Bruguerolle B. High plasma ropivacaine concentrations after fascia iliaca compartment block in children. Br J Anaesth. 2004 Mar;92(3):416-8. doi: 10.1093/bja/aeh066. Epub 2004 Jan 22.

    PubMed 14742340
  • Ward JP, Albert DB, Altman R, Goldstein RY, Cuff G, Youm T. Are femoral nerve blocks effective for early postoperative pain management after hip arthroscopy? Arthroscopy. 2012 Aug;28(8):1064-9. doi: 10.1016/j.arthro.2012.01.003. Epub 2012 Apr 11.

    PubMed 22498045
  • Morrison SR, Magaziner J, McLaughlin MA, Orosz G, Silberzweig SB, Koval KJ, Siu AL. The impact of post-operative pain on outcomes following hip fracture. Pain. 2003 Jun;103(3):303-311. doi: 10.1016/S0304-3959(02)00458-X.

    PubMed 12791436
  • Smith HS, Laufer A. Opioid induced nausea and vomiting. Eur J Pharmacol. 2014 Jan 5;722:67-78. doi: 10.1016/j.ejphar.2013.09.074. Epub 2013 Oct 21.

    PubMed 24157979
  • Marino J, Russo J, Kenny M, Herenstein R, Livote E, Chelly JE. Continuous lumbar plexus block for postoperative pain control after total hip arthroplasty. A randomized controlled trial. J Bone Joint Surg Am. 2009 Jan;91(1):29-37. doi: 10.2106/JBJS.H.00079.

    PubMed 19122076
  • Rashiq S, Vandermeer B, Abou-Setta AM, Beaupre LA, Jones CA, Dryden DM. Efficacy of supplemental peripheral nerve blockade for hip fracture surgery: multiple treatment comparison. Can J Anaesth. 2013 Mar;60(3):230-43. doi: 10.1007/s12630-012-9880-8. Epub 2013 Jan 19.

    PubMed 23334780

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Drug group Fascia iliaca nerve block in people with Hip Surgery Corrective and Anesthesia; Functional, run by Boston Children's Hospital 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 7 inclusion and 12 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: withdrawn, as of the sponsor's last update on 28 Jan 2022. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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?

The investigators will measure morphine consumption as the endpoint, to compare the efficacy of each group (time frame: Within the first 24hs after the fascia iliaca block is placed.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02717728, which also lists 6 linked publications.

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 28 Jan 2022.

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