Blocks for Intertrochanteric Fracture Repair Surgery

Not Applicable

• Conditions: Intertrochanteric Fractures
• Interventions: Other: General anesthesia; Other: Regional anesthesia- femoral and lateral femoral cutaneous nerve blocks

• Registration Number: NCT04470115
• Lead Sponsor: Military Institute od Medicine National Research Institute

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.

Study Timeline

• Study Start: 2019-01-01
• Status Verified: 2020-07
• Study First Submitted: 2020-07-01
• Study First Submitted QC: 2020-07-12
• Last Update Submitted: 2020-07-12
• Study First Posted: 2020-07-14
• Last Update Posted: 2020-07-14
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

• allergy to local anesthetics

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
General anesthesia	General anesthesia	Patients will receive general endotracheal anesthesia with propofol, fentanyl, sevoflurane and rocuronium.
Regional anesthesia	Regional anesthesia- femoral and lateral femoral cutaneous nerve blocks	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.

Primary Outcome Measures

Name	Time	Method
Percentage of patients suffering from major cardiovascular event during 30 days after the surgery.	30 days from the day of 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.
Percentage of patients suffering from postoperative delirium during 7 days after the surgery.	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.
Percentage of patients surviving 30 days after the surgery.	30 days from the day of 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.

Secondary Outcome Measures

Name	Time	Method
Opioid consumption	first 24 hours after surgery	Opioid (eg morphine) consumption will be noted
Pain score after surgery	first 24 hours 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.

Trial Locations

Locations (1)

Military Institute of Medicine; 🇵🇱 Warsaw, Poland