ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03226080
Recruitment Status : Recruiting
First Posted : July 21, 2017
Last Update Posted : August 14, 2018
Sponsor:
Information provided by (Responsible Party):
Scott Byram MD, Loyola University

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.

Condition or disease Intervention/treatment Phase
Hip Fractures Anesthesia, Spinal Anesthesia, General Neuromuscular Blockade Drug: Rocuronium Drug: Sugammadex Drug: Normal saline Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: The investigators, surgeons, intraoperative anesthesiology providers, and patients will be blinded.
Primary Purpose: Treatment
Official Title: Combined General and Spinal Anesthesia vs. Combined General and Spinal Anesthesia With Neuromuscular Blockade for Operative Repair of Hip Fractures
Actual Study Start Date : July 19, 2017
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Rocuronium

Arm Intervention/treatment
Placebo Comparator: 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.
Drug: Normal saline
Normal saline will be administered as a placebo in equal volume for the placebo group

Active Comparator: 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.
Drug: Rocuronium
The neuromuscular blockade group will receive intravenous rocuronium

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




Primary Outcome Measures :
  1. Time to complete reduction of the fracture [ Time Frame: Measured once Post-Op Day #0 in the recovery room ]
    Time necessary for complete reduction in the operating room.


Secondary Outcome Measures :
  1. Surgical Operative Conditions [ Time Frame: Measured once Post-Op Day #0 in the recovery room ]
    The surgeon's opinion of the operative conditions, as measured using a 4 point likert scale.

  2. Estimated Blood Loss [ Time Frame: Measured once Post-Op Day #0 in the recovery room ]
    Final estimated blood loss in mL for the procedure

  3. Total operating room time [ Time Frame: Measured once Post-Op Day #0 in the recovery room ]
    Total number of minutes spent in the operating room

  4. Time to extubation [ Time Frame: Measured once Post-Op Day #0 in the recovery room ]
    Total time from intubation to extubation

  5. Intraoperative fentanyl use [ Time Frame: Measured once Post-Op Day #0 in the recovery room ]
    Total amount (in mcg) of intravenous fentanyl used during the procedure



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03226080


Contacts
Contact: Scott Byram, MD 7082165988 sbyram@lumc.edu

Locations
United States, Illinois
Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60153
Contact: Scott Byram    708-216-5988    sbyram@lumc.edu   
Sub-Investigator: Michael Ander, MD         
Sub-Investigator: William Lack, MD         
Sub-Investigator: Michael Majewski, MD         
Sub-Investigator: Jonathan Metry, MD         
Sub-Investigator: Eric Pedone, MD         
Sub-Investigator: Lauren Bonzelaar, MD         
Sponsors and Collaborators
Loyola University

Publications:

Responsible Party: Scott Byram MD, Associate Professor, Loyola University
ClinicalTrials.gov Identifier: NCT03226080     History of Changes
Other Study ID Numbers: 209397
First Posted: July 21, 2017    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Hip Fractures
Fractures, Bone
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries
Anesthetics
Rocuronium
Central Nervous System Depressants
Physiological Effects of Drugs
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents