Effectiveness of Fascia Iliaca Nerve Block for Post Hip Arthroscopy

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

Interventions

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.

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.

Sponsors & Collaborators

• Boston Children's Hospital

  lead OTHER

Principal Investigators

• Yi-Meng Yen, MD · Boston Children's Hospital

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

12 Years

Max Age

35 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-12-31

Primary Completion

2021-12-31

Completion

2021-12-31

FDA Drug

Yes

Countries

• United States

Study Locations