Clinical trial NCT03226080: GA/Spinal vs. GA/Spinal/NMB for Operative Repair of Hip Fracture
Official title: Combined General and Spinal Anesthesia vs. Combined General and Spinal Anesthesia With Neuromuscular Blockade for Operative Repair of Hip Fractures
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Hip Fractures
Anesthesia, Spinal
Anesthesia, General
Neuromuscular Blockade
Lead sponsor: Loyola University
Sponsor class: OTHER
First posted: 2017-07-21
Enrollment: 0
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 84 patient under GA with spinal anesthesia will be block randomized to either neuromuscular blockade or placebo. Randomization will be tracked by the research pharmacist at Loyola University
Primary purpose: TREATMENT

Brief summary: Surgical repair of hip fractures may be performed with various anesthetic techniques, but are most commonly completed under general anesthesia (GA) or neuraxial anesthesia (NA). Numerous prospective and retrospective studies demonstrate improved morbidity and mortality when NA is used; however, many surgeons prefer the use of GA with neuromuscular blockade (NMB) due to the perception of better operative conditions. This study aims to compare the operative conditions obtained from the use of combined GA and spinal with NMB vs. the use of GA with spinal without NMB. 84 patients will all receive a single shot spinal and GA and then will be randomized to receive either NMB or placebo. The fracture reduction time will be measured.

Detailed description: Eighty-four ASA I-IV patients presenting for operative repair of an unstable intertrochanteric femur fracture will be enrolled. This will include fractures classified according to the Orthopaedic Trauma Association / Arbeitsgemeinschaft fur Osteosynthesisfragen (OTA/AO) classification system as 31A2.2, 31A2.3, 31A3.1, 31A3.2, and 31A3.3.15 After consent and upon arrival to the operating room, patients will be monitored and then sedated with midazolam, fentanyl, and ketamine as necessary per standard practice to facilitate lateral positioning. Patients will be positioned with the operative side down for the spinal blockade. Under sterile conditions, spinal anesthesia will be induced with 10mg (1.2mL) of hyperbaric 0.75% bupivicaine as per standard practice. The patient will then be given a standard general anesthetic induction consisting of propofol, succinylcholine, fentanyl, and lidocaine. The patient will be intubated and anesthesia will be maintained with desflurane in oxygen and air. At the time of incision, the patient will be randomized to one of two groups. The surgeon and the anesthesiologist will be blinded to the patient's randomization status. Group 1 (NMB) will be given IV rocuronium 0.6mg/kg in a volume of 10cc. Group 2 (placebo) will be given 10cc normal saline. The anesthesia practitioner will test a Train of Four (TOF) and confirm a return of twitches prior to administering the study intervention. The nerve stimulator will then be disconnected until the conclusion of the case. Hemodynamic changes which suggest light anesthesia will be treated with additional fentanyl in 50mcg increments and/or increasing the desflurane concentration. Any hypotension directly attributed to the anesthetic by the anesthetic practitioner will be managed using a phenylephrine bolus and/or infusion as per standard anesthetic practice. Surgery will be performed by one of three fellowship trained orthopedic trauma surgeons, and fixation of these fractures will be with a single type of cephalomedullary implant (Synthes TFN-A, West Chester, PA). These three surgeons employ an identical bed, patient position, and traction technique (sterile skeletal traction) for these procedures. A percutaneous reduction will first be attempted. If unsuccessful, an open reduction will then be pursued. Following adequate reduction, fixation with the cephalomedullary implant will then be completed. Once skin closure has been initiated, to reverse any NMB, sugammadex 200mg in 2ml will be given to those patients randomized to the NMB group, and 2mL normal saline for the placebo group. At the discretion of the attending anesthesiologist, a nerve stimulator may be reapplied not less than 5 minutes after NMB reversal (or saline) is given. Once the attending surgeon has evaluated the final radiographs, all patients will have their anesthetics discontinued and will be extubated after emergence from anesthesia.

Eligibility criteria: Inclusion Criteria:

* ASA I-IV Age 55 or older Scheduled for operative repair of isolated intertrochanteric hip fracture

Exclusion Criteria:

* Inability to consent/refusal Allergy to any of the study medications Multiple traumatic injuries Contraindication to neuraxial or general anesthesia Pregnancy

Primary outcomes:
measure: Time to complete reduction of the fracture
timeFrame: Measured once Post-Op Day #0 in the recovery room
Secondary outcomes:
measure: Surgical Operative Conditions
timeFrame: Measured once Post-Op Day #0 in the recovery room
measure: Estimated Blood Loss
timeFrame: Measured once Post-Op Day #0 in the recovery room
measure: Total operating room time
timeFrame: Measured once Post-Op Day #0 in the recovery room
measure: Time to extubation
timeFrame: Measured once Post-Op Day #0 in the recovery room
measure: Intraoperative fentanyl use
timeFrame: Measured once Post-Op Day #0 in the recovery room
Other outcomes:
Locations:
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
Study officials:
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