Blocks for Intertrochanteric Fracture Repair Surgery

NCT04470115 | Unknown

• 1 other identifier: 01_2019
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Intertrochanteric Fractures

Keywords

intratrochanteric fracture; general anesthesia; femoral nerve block; lateral femoral cutaneous nerve block

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Pain score after surgery

  first 24 hours after surgery

• Opioid consumption

  first 24 hours after surgery

Study Arms (2)

General anesthesia

ACTIVE COMPARATOR

Patients will receive general endotracheal anesthesia with propofol, fentanyl, sevoflurane and rocuronium.

Other: General anesthesia

Regional anesthesia

EXPERIMENTAL

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

Interventions

General anesthesia OTHER

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.

General anesthesia

Regional anesthesia- femoral and lateral femoral cutaneous nerve blocks OTHER

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.

Regional anesthesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• allergy to local anesthetics

Sponsors & Collaborators

• Military Institute od Medicine National Research Institute: lead

Study Sites (1)

Military Institute of Medicine

Warsaw, 04-141, Poland

RECRUITING

MeSH Terms

Conditions

Hip Fractures

Interventions

Anesthesia, General

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Central Study Contacts

Jakub Klimkiewicz, MD, PhD

CONTACT

0048261816896; jklimkiewicz@wim.mil.pl

Mateusz Gutowski, MD

CONTACT

0048261816896; mgutowski@wim.mil.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 1, 2020
• First Posted: July 14, 2020
• Study Start: January 1, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: July 14, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)