GA/Spinal vs. GA/Spinal/NMB for Operative Repair of Hip Fracture

NCT ID: NCT03226080

Last Updated: 2019-08-20

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-19
• Study Completion Date: 2020-08-31

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.

Conditions

Hip Fractures; Anesthesia, Spinal; Anesthesia, General; Neuromuscular Blockade

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Placebo

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 9mg (1.2mL) of hyperbaric 0.75% bupivacaine as per standard practice. The patient will then be given a standard general anesthetic induction consisting of propofol, succinylcholine, fentanyl, and lidocaine. At the time of incision, this group will be given 10cc normal saline. Once skin closure has been initiated, 2mL normal saline will be administered.

Group Type: PLACEBO_COMPARATOR

Normal saline

Intervention Type: DRUG

Normal saline will be administered as a placebo in equal volume for the placebo group

Neuromuscular Blockade

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 9mg (1.2mL) of hyperbaric 0.75% bupivacaine as per standard practice. The patient will then be given a standard general anesthetic induction consisting of propofol, succinylcholine, fentanyl, and lidocaine. At the time of incision, this group will be given IV rocuronium 0.6mg/kg in a volume of 10cc. Once skin closure has been initiated, sugammadex 200mg in 2ml will be administered.

Group Type: ACTIVE_COMPARATOR

Rocuronium

Intervention Type: DRUG

The neuromuscular blockade group will receive intravenous rocuronium

Sugammadex

Intervention Type: DRUG

The neuromuscular blockade group will receive intravenous sugammadex for reversal of residual rocuronium

Interventions

Rocuronium

The neuromuscular blockade group will receive intravenous rocuronium

Intervention Type: DRUG

Sugammadex

The neuromuscular blockade group will receive intravenous sugammadex for reversal of residual rocuronium

Intervention Type: DRUG

Normal saline

Normal saline will be administered as a placebo in equal volume for the placebo group

Intervention Type: DRUG

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

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Loyola University

OTHER

Sponsor Role: lead

Responsible Party

Scott Byram MD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Loyola University Medical Center

Maywood, Illinois, United States

Countries

United States

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Other Identifiers

209397

Identifier Type: -

Identifier Source: org_study_id