Blocks for Intertrochanteric Fracture Repair Surgery

Femoral Nerve Block Together With Lateral Femoral Cutaneous Nerve Block and Sedation as Anesthesia Among High Risk Patients With Intertrochanteric Fracture Repair Surgery

This single-center open label study compares the outcomes of surgical repair of intratrochanteric fracture under general anesthetic or peripheral nerve blocks.

Study Overview

• Status: Unknown
• Conditions: Intertrochanteric Fractures
• Intervention / Treatment: Other: General anesthesia; Other: Regional anesthesia- femoral and lateral femoral cutaneous nerve blocks

Detailed Description

This single-center open label study compares the outcomes of surgical repair of intratrochanteric fracture under general anesthetic or peripheral nerve blocks.

Patients are high risk individuals scheduled for intratrochanteric fracture repair, with contraindications to spinal anesthesia. One group will receive general endotracheal anesthetic, the other femoral and lateral femoral cutaneous nerve with deep sedation.

Mortality, morbidity (major cardiovascular incidents,delirium, pneumonia), pain scores and opioid consumption will be recorded.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jakub Klimkiewicz, MD, PhD; Phone Number: 0048261816896; Email: jklimkiewicz@wim.mil.pl
• Study Contact Backup: Name: Mateusz Gutowski, MD; Phone Number: 0048261816896; Email: mgutowski@wim.mil.pl

Study Locations

• Poland
  • Warsaw, Poland, 04-141
    • Recruiting
    • Military Institute of Medicine
    • Contact: Jakub Klimkiewicz, MD, PhD; Phone Number: 0048261816896; Email: jklimkiewicz@wim.mil.pl
    • Contact: Mateusz Gutowski, MD; Phone Number: 0048261816896; Email: mgutowski@wim.mil.pl
    • Principal Investigator: Jakub Klimkiewicz, MD, PhD
    • Principal Investigator: Mateusz Gutowski, MD
    • Sub-Investigator: Bartosz Rustecki, MD, PhD
    • Sub-Investigator: Dymitr Kochanowski, MD
    • Sub-Investigator: Anna Klimkiewicz, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• intratrochanteric fracture
• need for surgery
• contraindications for spinal anesthesia

Exclusion Criteria:

• allergy to local anesthetics

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: General anesthesia; Patients will receive general endotracheal anesthesia with propofol, fentanyl, sevoflurane and rocuronium.	Other: General anesthesia; Patients will receive general endotracheal anesthesia with typical drugs used (propofol, fentanyl, sevoflurane). the exact dose of the drug will be on the discretion of anesthesia provider, according to good clinical practice.
Experimental: Regional anesthesia; Patients will receive femoral and lateral femoral cutaneous nerves block under ultrasonographical guidance before operation.During surgical procedure they will receive deep sedation with propofol.	Other: Regional anesthesia- femoral and lateral femoral cutaneous nerve blocks; The femoral nerve (FN) is identified with ultrasound. The needle is inserted in-plane, from lateral to medial. We administer 15 to 17ml of local anesthetic (0.5 to 0.75% ropivacaine). After good anesthetic spread on FN we identify lateral femoral cutaneous nerve (LFCN) in its expected location 2-3 cm below inguinal ligament, laterally to sartorius muscle and inject usually 4 to 5 ml of local anesthetic. Oxygen 2-3 l/min is given via face mask to maintain Sp02 and the block is followed by sedation. Sedation is achieved with boluses of propofol to enable procedure and maintain patient in comfort. We aim to keep the depth of sedation at Ramsay sedation scale of 4. Whether it is possible we use loud verbal stimulus, if it is not we use gently glabella tap to assess depth of sedation. Patient is breathing spontaneously during the whole surgery. After surgical field is prepared, surgeon infiltrates expected entry points of intramedullary nail system with 0,5% lidocaine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients surviving 30 days after the surgery.	Numbers of survivors will be assessed on 30th day after the surgery. The result will be displayed as a percentage of examined group.	30 days from the day of the surgery.
Percentage of patients suffering from major cardiovascular event during 30 days after the surgery.	Occurence of stroke or acute coronary syndrome will be assessed during period of 30 postoperative days. The result will be displayed as a percentage of examined group.	30 days from the day of the surgery.
Percentage of patients suffering from postoperative delirium during 7 days after the surgery.	Occurence of postoperative delirium will be assessed during 7 days after the surgery. The result will be displayed as a percentage of examined group.	7 days after the surgery.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain score after surgery	Patients will be asked about their pain ranks 6 and 24 hours after surgery. The NRS score will be used (0 to 10) where 0 is no pain and 10 is extremely severe pain.	first 24 hours after surgery
Opioid consumption	Opioid (eg morphine) consumption will be noted	first 24 hours after surgery

Collaborators and Investigators

• Sponsor: Military Institute of Medicine, Poland

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: July 1, 2020
• First Submitted That Met QC Criteria: July 12, 2020
• First Posted (Actual): July 14, 2020

Study Record Updates

• Last Update Posted (Actual): July 14, 2020
• Last Update Submitted That Met QC Criteria: July 12, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: general anesthesia; femoral nerve block; intratrochanteric fracture; lateral femoral cutaneous nerve block
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Fractures, Bone; Hip Fractures; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 01_2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No