Blocks for Intertrochanteric Fracture Repair Surgery

NCT ID: NCT04470115

Last Updated: 2020-07-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2021-12-31

Brief Summary

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

Conditions

Intertrochanteric Fractures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

General anesthesia

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

Group Type: ACTIVE_COMPARATOR

General anesthesia

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Regional anesthesia- femoral and lateral femoral cutaneous nerve blocks

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• allergy to local anesthetics

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Military Institute od Medicine National Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Jakub Klimkiewicz

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Military Institute of Medicine

Warsaw, , Poland

Site Status: RECRUITING

Countries

Poland

Central Contacts

Jakub Klimkiewicz, MD, PhD

Role: CONTACT

jklimkiewicz@wim.mil.pl

0048261816896

Mateusz Gutowski, MD

Role: CONTACT

mgutowski@wim.mil.pl

0048261816896

Facility Contacts

Jakub Klimkiewicz, MD, PhD

Role: primary

jklimkiewicz@wim.mil.pl

0048261816896

Mateusz Gutowski, MD

Role: backup

mgutowski@wim.mil.pl

0048261816896

Other Identifiers

01_2019

Identifier Type: -

Identifier Source: org_study_id