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Trial record 20 of 57 for:    Recruiting, Not yet recruiting, Available Studies | Arthroscopy

Effectiveness of Fascia Iliaca Nerve Block for Post Hip Arthroscopy

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ClinicalTrials.gov Identifier: NCT02717728
Recruitment Status : Not yet recruiting
First Posted : March 24, 2016
Last Update Posted : December 4, 2018
Sponsor:
Information provided by (Responsible Party):
Karen Boretsky, Boston Children’s Hospital

Brief 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. 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.

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).


Condition or disease Intervention/treatment Phase
Hip Surgery Corrective Anesthesia; Functional Procedure: Drug group Fascia iliaca nerve block Procedure: Control group sham nerve block Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effectiveness of Fascia Iliaca Nerve Block for Post Hip Arthroscopy Pain Management: A Randomized Double-blind, Placebo Controlled Study
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Active Comparator: Drug group Fascia iliaca nerve block

Device: 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.

Procedure: Drug group Fascia iliaca nerve block

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.


Sham Comparator: Control group sham nerve block

Device: 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.

Procedure: Control group sham nerve block

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.





Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  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 [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: Within the first hour after the fascia iliaca block is placed. ]


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Ages Eligible for Study:   12 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Hip revision surgery
  2. Underlying neurologic disorder affecting pain perception.
  3. Underlying neurocognitive disorder or developmental delay affecting ability to convey feelings of pain to medical staff.
  4. Underlying opioid use or addiction.
  5. Significant concomitant hip pathology.
  6. Active infection over catheter site.
  7. 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.
  8. Allergy to local anesthetics
  9. Allergy to fentanyl
  10. Allergy to midazolam
  11. Allergy to morphine
  12. American Society of Anesthesia class 3 or higher.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02717728


Contacts
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Contact: wasin Luckanavanich, Coordinator 857-218-3272 wasin.luckanavanich@childrens.harvard.edu
Contact: karen r boretsky, md 4128187798 karen.boretsky@childrens.harvard.edu

Locations
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United States, Massachusetts
Boston Children's Hospital Not yet recruiting
Boston, Massachusetts, United States, 02115
Contact: Wasin Luckanavanich, Coordinator    857-218-3272    wasin.Luckanavanich@childrens.harvard.edu   
Sub-Investigator: Karen R Boretsky, MD         
Principal Investigator: Yi-Meng Yen, MD         
Sponsors and Collaborators
Boston Children’s Hospital
Investigators
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Principal Investigator: Yi-Meng Yen, MD Boston Children’s Hospital

Publications of Results:
Other Publications:
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Responsible Party: Karen Boretsky, Dr. Karen Boretsky, Boston Children’s Hospital
ClinicalTrials.gov Identifier: NCT02717728     History of Changes
Other Study ID Numbers: IRB-P00021561
First Posted: March 24, 2016    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents