Effectiveness of Fascia Iliaca Nerve Block for Post Hip Arthroscopy

NCT02717728 | Withdrawn Phase 3 DMC FDA Drug

• 1 other identifier: IRB-P00021561
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Hip Surgery Corrective; Anesthesia; Functional

Outcome Measures

Primary Outcomes (1)

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

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

Secondary Outcomes (4)

• The investigators will collect postoperative pain scores using the 11 point numeric rating scale in each group, to compare the efficacy of each group

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

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

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

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

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

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

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

Study Arms (2)

Drug group Fascia iliaca nerve block

ACTIVE COMPARATOR

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

Control group sham nerve block

SHAM COMPARATOR

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

Interventions

Drug group Fascia iliaca nerve block PROCEDURE

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.

Drug group Fascia iliaca nerve block

Control group sham nerve block PROCEDURE

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.

Control group sham nerve block

Eligibility Criteria

• Age: 12 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (6)

• 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.

  PMID: 14742340 BACKGROUND

• 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.

  PMID: 22498045 RESULT

• 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.

  PMID: 12791436 RESULT

• 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.

  PMID: 24157979 RESULT

• 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.

  PMID: 19122076 RESULT

• 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.

  PMID: 23334780 RESULT

Study Officials

• Yi-Meng Yen, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Karen Boretsky

Study Record Dates

• First Submitted: January 26, 2016
• First Posted: March 24, 2016
• Study Start: December 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: January 28, 2022

Record last verified: 2022-01

Locations

US (1)