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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04470115
Enrollment
100
Registered
2020-07-14
Start date
2019-01-01
Completion date
2021-12-31
Last updated
2020-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intertrochanteric Fractures

Keywords

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

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.

Interventions

OTHERGeneral 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.

OTHERRegional 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.

Sponsors

Military Institute od Medicine National Research Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* allergy to local anesthetics

Design outcomes

Primary

MeasureTime frameDescription
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.
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.

Secondary

MeasureTime frameDescription
Pain score after surgeryfirst 24 hours after surgeryPatients 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.
Opioid consumptionfirst 24 hours after surgeryOpioid (eg morphine) consumption will be noted

Countries

Poland

Contacts

Primary ContactJakub Klimkiewicz, MD, PhD
jklimkiewicz@wim.mil.pl0048261816896
Backup ContactMateusz Gutowski, MD
mgutowski@wim.mil.pl0048261816896

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026