Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This single-center open label study compares the outcomes of surgical repair of intratrochanteric fracture under general anesthetic or peripheral nerve blocks.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| General anesthesia | Active Comparator | Patients will receive general endotracheal anesthesia with propofol, fentanyl, sevoflurane and rocuronium. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Opioid consumption |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jakub Klimkiewicz, MD, PhD | Contact | 0048261816896 | jklimkiewicz@wim.mil.pl | |
| Mateusz Gutowski, MD | Contact | 0048261816896 | mgutowski@wim.mil.pl |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Military Institute of Medicine | Recruiting | Warsaw | 04-141 | Poland |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
Not provided
Not provided
| ID | Term |
|---|---|
| D000768 | Anesthesia, General |
| ID | Term |
|---|---|
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. |
|
Opioid (eg morphine) consumption will be noted
| first 24 hours after surgery |
| D007869 |
| Leg Injuries |