search
Back to results

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

Primary Purpose

Hip Fractures, Anesthesia, Spinal, Anesthesia, General

Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Rocuronium
Sugammadex
Normal saline
Sponsored by
Loyola University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Fractures

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Loyola University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Neuromuscular Blockade

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Time to complete reduction of the fracture
Time necessary for complete reduction in the operating room.

Secondary Outcome Measures

Surgical Operative Conditions
The surgeon's opinion of the operative conditions, as measured using a 4 point likert scale.
Estimated Blood Loss
Final estimated blood loss in mL for the procedure
Total operating room time
Total number of minutes spent in the operating room
Time to extubation
Total time from intubation to extubation
Intraoperative fentanyl use
Total amount (in mcg) of intravenous fentanyl used during the procedure

Full Information

First Posted
May 1, 2017
Last Updated
August 17, 2019
Sponsor
Loyola University
search

1. Study Identification

Unique Protocol Identification Number
NCT03226080
Brief Title
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

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Study terminated with IRB on 20Feb2019 due to lack of enrollment.
Study Start Date
July 19, 2017 (Actual)
Primary Completion Date
August 2019 (Anticipated)
Study Completion Date
August 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Loyola University

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures, Anesthesia, Spinal, Anesthesia, General, Neuromuscular Blockade

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigatorOutcomes Assessor
Masking Description
The investigators, surgeons, intraoperative anesthesiology providers, and patients will be blinded.
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Neuromuscular Blockade
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Rocuronium
Intervention Description
The neuromuscular blockade group will receive intravenous rocuronium
Intervention Type
Drug
Intervention Name(s)
Sugammadex
Intervention Description
The neuromuscular blockade group will receive intravenous sugammadex for reversal of residual rocuronium
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
Normal saline will be administered as a placebo in equal volume for the placebo group
Primary Outcome Measure Information:
Title
Time to complete reduction of the fracture
Description
Time necessary for complete reduction in the operating room.
Time Frame
Measured once Post-Op Day #0 in the recovery room
Secondary Outcome Measure Information:
Title
Surgical Operative Conditions
Description
The surgeon's opinion of the operative conditions, as measured using a 4 point likert scale.
Time Frame
Measured once Post-Op Day #0 in the recovery room
Title
Estimated Blood Loss
Description
Final estimated blood loss in mL for the procedure
Time Frame
Measured once Post-Op Day #0 in the recovery room
Title
Total operating room time
Description
Total number of minutes spent in the operating room
Time Frame
Measured once Post-Op Day #0 in the recovery room
Title
Time to extubation
Description
Total time from intubation to extubation
Time Frame
Measured once Post-Op Day #0 in the recovery room
Title
Intraoperative fentanyl use
Description
Total amount (in mcg) of intravenous fentanyl used during the procedure
Time Frame
Measured once Post-Op Day #0 in the recovery room

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
16983459
Citation
Johnell O, Kanis JA. An estimate of the worldwide prevalence and disability associated with osteoporotic fractures. Osteoporos Int. 2006 Dec;17(12):1726-33. doi: 10.1007/s00198-006-0172-4. Epub 2006 Sep 16.
Results Reference
background
PubMed Identifier
22713634
Citation
Neuman MD, Silber JH, Elkassabany NM, Ludwig JM, Fleisher LA. Comparative effectiveness of regional versus general anesthesia for hip fracture surgery in adults. Anesthesiology. 2012 Jul;117(1):72-92. doi: 10.1097/ALN.0b013e3182545e7c.
Results Reference
background
PubMed Identifier
16299013
Citation
Roche JJ, Wenn RT, Sahota O, Moran CG. Effect of comorbidities and postoperative complications on mortality after hip fracture in elderly people: prospective observational cohort study. BMJ. 2005 Dec 10;331(7529):1374. doi: 10.1136/bmj.38643.663843.55. Epub 2005 Nov 18.
Results Reference
background
PubMed Identifier
25955981
Citation
Chu CC, Weng SF, Chen KT, Chien CC, Shieh JP, Chen JY, Wang JJ. Propensity Score-matched Comparison of Postoperative Adverse Outcomes between Geriatric Patients Given a General or a Neuraxial Anesthetic for Hip Surgery: A Population-based Study. Anesthesiology. 2015 Jul;123(1):136-47. doi: 10.1097/ALN.0000000000000695.
Results Reference
background
PubMed Identifier
25922465
Citation
Basques BA, Bohl DD, Golinvaux NS, Samuel AM, Grauer JG. General versus spinal anaesthesia for patients aged 70 years and older with a fracture of the hip. Bone Joint J. 2015 May;97-B(5):689-95. doi: 10.1302/0301-620X.97B5.35042.
Results Reference
background
PubMed Identifier
11118174
Citation
Rodgers A, Walker N, Schug S, McKee A, Kehlet H, van Zundert A, Sage D, Futter M, Saville G, Clark T, MacMahon S. Reduction of postoperative mortality and morbidity with epidural or spinal anaesthesia: results from overview of randomised trials. BMJ. 2000 Dec 16;321(7275):1493. doi: 10.1136/bmj.321.7275.1493.
Results Reference
background
PubMed Identifier
27496656
Citation
Bulka CM, Terekhov MA, Martin BJ, Dmochowski RR, Hayes RM, Ehrenfeld JM. Nondepolarizing Neuromuscular Blocking Agents, Reversal, and Risk of Postoperative Pneumonia. Anesthesiology. 2016 Oct;125(4):647-55. doi: 10.1097/ALN.0000000000001279.
Results Reference
background
PubMed Identifier
27537929
Citation
Stewart PA, Liang SS, Li QS, Huang ML, Bilgin AB, Kim D, Phillips S. The Impact of Residual Neuromuscular Blockade, Oversedation, and Hypothermia on Adverse Respiratory Events in a Postanesthetic Care Unit: A Prospective Study of Prevalence, Predictors, and Outcomes. Anesth Analg. 2016 Oct;123(4):859-68. doi: 10.1213/ANE.0000000000001513.
Results Reference
background
PubMed Identifier
20657202
Citation
Chang CC, Lin HC, Lin HW, Lin HC. Anesthetic management and surgical site infections in total hip or knee replacement: a population-based study. Anesthesiology. 2010 Aug;113(2):279-84. doi: 10.1097/ALN.0b013e3181e2c1c3.
Results Reference
background
PubMed Identifier
27380106
Citation
Zorrilla-Vaca A, Grant MC, Mathur V, Li J, Wu CL. The Impact of Neuraxial Versus General Anesthesia on the Incidence of Postoperative Surgical Site Infections Following Knee or Hip Arthroplasty: A Meta-Analysis. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):555-63. doi: 10.1097/AAP.0000000000000437.
Results Reference
background
PubMed Identifier
17000823
Citation
Mauermann WJ, Shilling AM, Zuo Z. A comparison of neuraxial block versus general anesthesia for elective total hip replacement: a meta-analysis. Anesth Analg. 2006 Oct;103(4):1018-25. doi: 10.1213/01.ane.0000237267.75543.59.
Results Reference
background
PubMed Identifier
16632842
Citation
Minville V, Fourcade O, Grousset D, Chassery C, Nguyen L, Asehnoune K, Colombani A, Goulmamine L, Samii K. Spinal anesthesia using single injection small-dose bupivacaine versus continuous catheter injection techniques for surgical repair of hip fracture in elderly patients. Anesth Analg. 2006 May;102(5):1559-63. doi: 10.1213/01.ane.0000218421.18723.cf.
Results Reference
background
PubMed Identifier
8448099
Citation
Mazze RI, Fujinaga M. Postdural puncture headache after continuous spinal anesthesia with 18-gauge and 20-gauge needles. Reg Anesth. 1993 Jan-Feb;18(1):47-51.
Results Reference
background
PubMed Identifier
8104724
Citation
Holmstrom B, Laugaland K, Rawal N, Hallberg S. Combined spinal epidural block versus spinal and epidural block for orthopaedic surgery. Can J Anaesth. 1993 Jul;40(7):601-6. doi: 10.1007/BF03009695.
Results Reference
background
PubMed Identifier
18277234
Citation
Marsh JL, Slongo TF, Agel J, Broderick JS, Creevey W, DeCoster TA, Prokuski L, Sirkin MS, Ziran B, Henley B, Audige L. Fracture and dislocation classification compendium - 2007: Orthopaedic Trauma Association classification, database and outcomes committee. J Orthop Trauma. 2007 Nov-Dec;21(10 Suppl):S1-133. doi: 10.1097/00005131-200711101-00001.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs