Blocks for Intertrochanteric Fracture Repair Surgery

Intertrochanteric Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04470115
• Other study ID #: 01_2019
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: July 2020
• Source: Military Institute of Medicine, Poland
• Contact: Jakub Klimkiewicz, MD, PhD
• Phone: 0048261816896
• Email: jklimkiewicz[@]wim.mil.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• intratrochanteric fracture

• need for surgery

• contraindications for spinal anesthesia

Exclusion Criteria:

• allergy to local anesthetics

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fractures
• Intertrochanteric Fractures

Intervention

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.
• 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.

Locations

Country	Name	City	State
Poland	Military Institute of Medicine	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Military Institute of Medicine, Poland

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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	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
Secondary	Opioid consumption	Opioid (eg morphine) consumption will be noted	first 24 hours after surgery