Suprainguinal Fascia Iliaca Compartment Block in Direct Anterior Approach to Total Hip Arthroplasty

NCT05237479 | Withdrawn DMC

• 1 other identifier: 2021-13705
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this study is to determine whether or not a suprainguinal fascia iliaca compartment nerve block is effective at improving postoperative pain control in patients receiving an anterior approach hip replacement surgery. In general, postoperative pain control has a significant impact on earlier ambulation, initiation of physical therapy, better functional recovery, and overall patient satisfaction. The hypothesis is that providing patients with this nerve block will decrease opioid requirements in patients undergoing this surgery as compared to patients that do not receive the block.

Conditions

Anesthesia, Local; Block

Outcome Measures

Primary Outcomes (2)

• Morphine Milligram Equivalent (MME)

  Morphine Milligram Equivalent use in PACU

  In PACU (1-2 hours postoperatively)

• Morphine Milligram Equivalent (MME)

  Morphine Milligram Equivalent use post-op

  24 hours postoperatively

Secondary Outcomes (8)

• Sensory and Motor Distribution of LFCN, FN and ON

  Preoperatively prior to surgery

• Sensory and Motor Distribution of LFCN, FN and ON

  Postoperatively 24 hours after surgery

• Length of Hospital Stay

  Up to 7 days

• Patient satisfaction of acute postoperative pain management experience

  24 hours post discharge

• Pain scores in PACU

  PACU stay

Study Arms (2)

Control Group

PLACEBO COMPARATOR

DAA THA under spinal anesthesia ( standard of care at Montefiore)

Other: Placebo

Intervention Group

ACTIVE COMPARATOR

DAA THA under spinal anesthesia and a preoperative supra-inguinal fascia iliac compartment block (S-FICB)

Procedure: Suprainguinal fascia ilica block

Interventions

Suprainguinal fascia ilica block PROCEDURE

Patients who have been randomized to Group B Intervention will receive a preoperative S-FICB using 35ml of 0.5% ropivacaine under ultrasound guidance by the regional anesthesia block team once patient has been marked by surgeon. Sensory \& motor distribution of the LFCN, FN, \& ON will be assessed by the regional anesthesia team in the preop area for patients randomized to the control group prior to surgery. Patients who received a S-FICB in preop, approximately 15 minutes after the block, sensory \& motor distribution of LFCN, FN, \& ON will be assessed by the regional anesthesia block team prior to going to the operating room. All patients, regardless of group allocation, will be followed by the acute pain service team on postoperative day one to assess sensory \& motor distribution of LFCN, FN, \& ON \& adjustment of pain medication regimens. All patients will receive a call from a research assistant blinded to group allocation 24 hours post-discharge for a patient satisfaction survey.

Intervention Group

Placebo OTHER

The sensory and motor distribution of the LFCN, FN, and ON will be assessed by the regional anesthesia team in the preop area for patients randomized to the control group prior to surgery.

Control Group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing primary elective total hip arthroplasty under direct anterior surgical approach
• ASA Class I-III
• Age \> 18 years old

You may not qualify if:

• Patient refusal
• Inability to understand and sign an informed consent
• Infection at the injection site
• Allergy or hypersensitivity to ropivacaine or other amide local anesthetics
• Contraindication or patient refusal to get spinal anesthesia
• Thrombocytopenia (Platelets \< 100, 000)
• Coagulopathy (INR \> 1.4)
• Use of anticoagulant drugs that have not been discontinued in an appropriate amount of time - according to American Society of Regional Anesthesia guidelines, prior to surgery
• End-Stage Renal Disease
• ASA Class IV-V
• Patients on chronic opioid therapy on most days for \> 3 months \[19\].
• BMI\>40

Sponsors & Collaborators

• Montefiore Medical Center: lead

Related Publications (20)

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MeSH Terms

Conditions

Bites and Stings

Condition Hierarchy (Ancestors)

Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Study Officials

• Sofia steinberg, DO

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: On the day of surgery, a sealed envelope with group allocation (Group A- Control vs. Group B - Intervention) will be opened by a team member not involved with data collection. A separate anesthesia team consisting of an anesthesiologist and certified nurse anesthetist will be responsible for the spinal anesthetic and monitored anesthesia care for both groups in the operating room A separate acute pain service team will follow the patients in both groups on postoperative day 1 and evaluate sensory and motor distribution of LFCN, FN, and ON for both groups A research assistant blinded to the allocation of both groups will collect data from the EMR for analysis. In addition, a research assistant blinded to the allocation of both groups will call patients via telephone 24 hours post-discharge for a patient satisfaction survey.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2022
• First Posted: February 14, 2022
• Study Start: June 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: October 4, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share