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Spinal Versus General Anesthesia With Popliteal and Adductor Canal Blocks for Ambulatory Foot and Ankle Surgery. (LMA vs Spinal)

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ClinicalTrials.gov Identifier: NCT02996591
Recruitment Status : Completed
First Posted : December 19, 2016
Results First Posted : November 12, 2019
Last Update Posted : November 12, 2019
Sponsor:
Information provided by (Responsible Party):
Hospital for Special Surgery, New York

Tracking Information
First Submitted Date  ICMJE December 2, 2016
First Posted Date  ICMJE December 19, 2016
Results First Submitted Date  ICMJE June 15, 2018
Results First Posted Date  ICMJE November 12, 2019
Last Update Posted Date November 12, 2019
Actual Study Start Date  ICMJE January 2017
Actual Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 7, 2019)
Time Until Patient is Ready for Discharge From Post-Anesthesia Care Unit (PACU) to Home. [ Time Frame: Duration of stay in recovery room after surgery ]
Modified Aldrete Scoring System and Marshall and Chung Postanesthesia Discharge Scoring System, measured in time until discharge criteria is met (in minutes)
Original Primary Outcome Measures  ICMJE
 (submitted: December 14, 2016)
Readiness for discharge to home [ Time Frame: Duration of stay in recovery room after surgery (average 2 hours) ]
Modified Aldrete Scoring System and Marshall and Chung Postanesthesia Discharge Scoring System
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 7, 2019)
  • Numerical Rating Scale (NRS) Pain Scores at 1 Hour Postop [ Time Frame: 1 hour after PACU admission ]
    NRS Pain scores at 1 hour after surgery. Rated on a scale of 0 (no pain) to 10 (worst pain imaginable).
  • Numerical Rating Scale Pain Scores at 2 Hours Postop [ Time Frame: 2 hours after PACU admission ]
    Numerical rating scale pain score as reported by the patient at 2 hours post-operatively. Rated on a scale of 0 (no pain) to 10 (worst pain imaginable).
  • Numerical Rating Scale Pain Scores on Postoperative Day (POD) 1 [ Time Frame: 24 hours after surgery ]
    Numerical Rating Scale Pain from 0-10. 0 being no pain at all. 10 being the worst pain imaginable.
  • Postoperative Discomfort and Needs (Post-op Pain, Sore Throat, Back Pain, Nausea, Cold, Hunger, Thirst) [ Time Frame: 1 hour after surgery ]
    Leiden Perioperative Care Patient Satisfaction questionnaire (LPPSq) score. Performed at 1 hour postoperatively. To what degree did patients have the following symptoms. Rated 1-5, 1 being not at all. 5 being extremely.
  • Postoperative Discomfort and Needs (Post-op Pain, Sore Throat, Back Pain, Nausea, Cold, Hunger, Thirst) [ Time Frame: 2 hours after surgery ]
    Rating the Nausea/Vomiting of patients post-operatively.
  • Postoperative Discomfort and Needs (Post-op Pain, Sore Throat, Back Pain, Nausea, Cold, Hunger, Thirst) [ Time Frame: Postoperative day 1 ]
    Leiden Perioperative Care Patient Satisfaction questionnaire (LPPSq). From 1-5. 1 being not at all. 5 being extremely.
  • Incidence of Post-dural Puncture Headache [ Time Frame: Postoperative day 1 and if present, monitored until resolution ]
  • Incidence of Transient Neurologic Symptoms [ Time Frame: Postoperative day 1 and if present, monitored until resolution ]
  • Opioid Consumption [ Time Frame: Duration of stay in recovery room after surgery (average 2 hours) ]
    Opioid consumption (mg OME) during inpatient stay
  • Opioid Consumption Through First Postoperative Day. Measured in mg OME [ Time Frame: Postoperative day 1 ]
  • Non-opioid Analgesic Consumption [ Time Frame: Hospital discharge to postoperative day 1 ]
    The number of patients who took non-opioid analgesic medication for post-operative pain between hospital discharge and postoperative day 1.
  • Opioid-Related Symptom Distress Scale (ORSDS) Score [ Time Frame: 2 hours after surgery ]
    Opioid-related symptom distress scale. The ORSDS measures patient opioid-related symptoms on a 4-point scale that evaluates 3 symptom distress dimension (severity, frequency, and bothersomeness) for 12 opioid-related symptoms. Scores range from 0-4, and the mean of the 12 answers is the ORSDS score. Higher values indicate worse opioid-related symptoms.
  • Cognitive Recovery [ Time Frame: 1 hour after surgery ]
    Postoperative Quality Recovery Scale Cognitive Domain questionnaire. Asked at 1 hour post-operatively. Either yes (return to pre-operative cognitive function levels) or no (not yet returned to pre-operative function levels)
  • Incidence of Urinary Catheterization [ Time Frame: Duration of stay in recovery room after surgery (average 2 hours) ]
  • Anesthesia-related Postoperative Complications [ Time Frame: Surgery start to postoperative day 1 ]
    Measuring any anesthesia-related post-op complications that occured (yes or no)
  • Assessment of Patient Blinding to Group Assignment [ Time Frame: Postoperative day 1 ]
    Patients will be asked whether they believe they were in the general anesthesia or spinal anesthesia group. These responses are then validated using the Bang Blinding Index, which either confirms or refutes the validity of the blinding. The scale runs from -1 to 1, with a score of 0 indicating complete blinding, -1 indicating opposite guessing of groups, and 1 indicating a complete lack of blinding.
  • Patient Satisfaction [ Time Frame: POD1 ]
    Yes/no if patients would request the same anesthetic that they received
  • Cognitive Recovery at 2 Hours Post-operative [ Time Frame: 2 hours after PACU admission ]
    Postoperative Quality Recovery Scale Cognitive Domain questionnaire. Asked at 2 hour post-operatively. Either yes (return to pre-operative cognitive function levels) or no (not yet returned to pre-operative function levels)
  • Cognitive Recovery on POD1 [ Time Frame: Postoperative day 1 ]
    Postoperative Quality Recovery Scale Cognitive Domain questionnaire. Asked on postoperative day 1. Either yes (return to pre-operative cognitive function levels) or no (not yet returned to pre-operative function levels)
  • Nausea Intensity [ Time Frame: 2 hours after PACU admission ]
    Nausea intensity ranked on NRS score following PACU admission to 2 hours after discharge. Scored from 0-10. 0 Being no nausea, 10 being worst nausea imaginable.
  • Back Pain on POD1 [ Time Frame: Postoperative day 1 ]
    Back pain (yes/no) on POD1
Original Secondary Outcome Measures  ICMJE
 (submitted: December 14, 2016)
  • Numerical rating scale pain scores [ Time Frame: 1 hour after surgery, 2 hours after surgery ]
  • Patient satisfaction with perioperative care [ Time Frame: Postoperative day 1 ]
    Leiden Perioperative Care Patient Satisfaction questionnaire (LPPSq)
  • Postoperative Discomfort and Needs (Post-op Pain, Sore Throat, Back Pain, Nausea, Cold, Hunger, Thirst) [ Time Frame: 1 hour after surgery, 2 hours after surgery, postoperative day 1 ]
    Leiden Perioperative Care Patient Satisfaction questionnaire (LPPSq)
  • Numerical rating scale nausea and vomiting [ Time Frame: 1 hour after surgery, 2 hours after surgery, postoperative day 1 ]
  • Incidence of Post-dural Puncture Headache [ Time Frame: Postoperative day 1 and if present, monitored until resolution ]
  • Incidence of Transient Neurologic Symptoms [ Time Frame: Postoperative day 1 and if present, monitored until resolution ]
  • Opioid Consumption [ Time Frame: Duration of stay in recovery room after surgery (average 2 hours), postoperative day 1 ]
  • Non-opioid analgesic consumption [ Time Frame: Duration of stay in recovery room after surgery (average 2 hours), postoperative day 1 ]
  • Side effects [ Time Frame: 2 hours after surgery ]
    Opioid-related symptom distress scale
  • Cognitive recovery [ Time Frame: 1 hour after surgery, 2 hours after surgery, postoperative day 1 ]
    Postoperative Quality Recovery Scale Cognitive Domain
  • Incidence of Urinary Catheterization [ Time Frame: Duration of stay in recovery room after surgery (average 2 hours) ]
  • Anesthesia-related Postoperative Complications [ Time Frame: Duration of stay in recovery room after surgery (average 2 hours), postoperative day 1 ]
  • Assessment of patient blinding to group assignment [ Time Frame: Postoperative day 1 ]
    Patients will be asked whether they believe they were in the general anesthesia or spinal anesthesia group.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Spinal Versus General Anesthesia With Popliteal and Adductor Canal Blocks for Ambulatory Foot and Ankle Surgery.
Official Title  ICMJE Spinal Versus General Anesthesia With Popliteal and Adductor Canal Blocks for Ambulatory Foot and Ankle Surgery: A Double-Blinded Randomized Controlled Trial.
Brief Summary

The purpose of this study is to determine if there is a difference in patient outcomes with general anesthesia versus spinal anesthesia when given in addition to popliteal and adductor canal nerve blocks for foot and ankle surgery. Popliteal and adductor canal nerve blocks are injections of local anesthetic agents near nerves in the back and front of the knee going to the foot and ankle that provide numbness during and after surgery. These peripheral nerve blocks offer good pain control and reduce the need for opioids (opioids are pain medications such as morphine, Dilaudid, and oxycodone). General anesthesia involves the flow of oxygen and anesthesia gas through a tube which, along with additional intravenous medications, causes unconsciousness and unawareness of sensations during surgery. Spinal anesthesia involves an injection of local anesthetic in the lower back, which causes numbness below the waist. In addition to spinal anesthesia, a sedative is typically given intravenously to cause relaxation and sleepiness throughout surgery.

General, spinal, and nerve block anesthesia are all routinely used for surgery at the Hospital for Special Surgery. General or spinal anesthesia is typically used in addition to peripheral nerve blocks during foot and ankle surgery to 1) allow the surgeons to use a thigh tourniquet to reduce bleeding, 2) provide anesthesia earlier, and 3) prevent unwanted movement. However, it is unclear whether general or spinal anesthesia provides better patient outcomes when given with peripheral nerve blocks. Some reports show that on its own, spinal anesthesia has advantages over general anesthesia in terms of side effects such as nausea and pain. However, these advantages may also be gained from combining peripheral nerve blocks with general anesthesia. Spinal anesthesia can be associated with headache and backache, although headache and backache can also happen after operations performed with general anesthesia. A previous study at the Hospital for Special Surgery showed low rates of nausea among patients who received nerve blocks with spinal anesthesia, and no nausea among patients who received a nerve block with general anesthesia. Therefore, the primary aim of this study is to determine if, as a treatment, either general or spinal anesthesia has advantages over the other treatment in terms of readiness for discharge, side effects, pain and patient satisfaction in an ambulatory foot and ankle population.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Nerve Block
  • General Anesthesia
  • Spinal Anesthesia
  • Pain
  • Postoperative Nausea and Vomiting
Intervention  ICMJE
  • Procedure: 25 mL of 0.25% bupivacaine plus 2 mg preservative-free (PF) dexamethasone / 30 ml for popliteal nerve block
  • Procedure: 10 mL of 0.25% bupivacaine plus 2 mg preservative-free (PF) dexamethasone / 30 ml for adductor canal nerve block
  • Drug: Midazolam, 2-5 mg IV + Glycopyrrolate, 0.1 mg IV + Ketamine, 10-20 mg + propofol as needed
  • Procedure: 45-60 mg of 1.5% mepivacaine for spinal anesthesia
  • Procedure: LMA insertion + titrated propofol infusion + sevoflurane + ketamine 10 mg/hr for general anesthesia
Study Arms  ICMJE
  • Active Comparator: Spinal anesthesia with popliteal and adductor canal blocks.
    Ultrasound (US) guided sciatic nerve blocks in the popliteal fossa and adductor canal block with 25 mL and 10 mL, respectively, of 0.25% bupivacaine (plus 2 mg preservative-free (PF) dexamethasone / 30 ml), performed under procedural IV sedation protocol. IV sedation protocol: midazolam, 2-5 mg IV + Glycopyrrolate, 0.1 mg IV + Ketamine, 10-20 mg, + propofol as needed. Spinal protocol: 45-60 mg 1.5% mepivacaine, depending on the expected case duration (45 mg for cases with projected duration 1-2 hours, 60 mg for cases with projected duration 2-3 hours). Intraoperative sedation maintained with propofol infusion and ketamine, 10 mg/hr.
    Interventions:
    • Procedure: 25 mL of 0.25% bupivacaine plus 2 mg preservative-free (PF) dexamethasone / 30 ml for popliteal nerve block
    • Procedure: 10 mL of 0.25% bupivacaine plus 2 mg preservative-free (PF) dexamethasone / 30 ml for adductor canal nerve block
    • Drug: Midazolam, 2-5 mg IV + Glycopyrrolate, 0.1 mg IV + Ketamine, 10-20 mg + propofol as needed
    • Procedure: 45-60 mg of 1.5% mepivacaine for spinal anesthesia
  • Active Comparator: General anesthesia with popliteal and adductor canal blocks.
    Ultrasound (US) guided sciatic nerve blocks in the popliteal fossa and adductor canal block with 25 mL and 10 mL, respectively, of 0.25% bupivacaine (plus 2 mg preservative-free (PF) dexamethasone / 30 ml), performed under procedural IV sedation protocol. IV sedation protocol: midazolam, 2-5 mg IV + Glycopyrrolate, 0.1 mg IV + Ketamine, 10-20 mg, + propofol as needed. General anesthesia protocol: After induction with propofol and insertion of the LMA, anesthesia maintained with titrated propofol infusion, sevoflurane, ketamine 10 mg/hr.
    Interventions:
    • Procedure: 25 mL of 0.25% bupivacaine plus 2 mg preservative-free (PF) dexamethasone / 30 ml for popliteal nerve block
    • Procedure: 10 mL of 0.25% bupivacaine plus 2 mg preservative-free (PF) dexamethasone / 30 ml for adductor canal nerve block
    • Drug: Midazolam, 2-5 mg IV + Glycopyrrolate, 0.1 mg IV + Ketamine, 10-20 mg + propofol as needed
    • Procedure: LMA insertion + titrated propofol infusion + sevoflurane + ketamine 10 mg/hr for general anesthesia
Publications * YaDeau JT, Fields KG, Kahn RL, LaSala VR, Ellis SJ, Levine DS, Paroli L, Luu TH, Roberts MM. Readiness for Discharge After Foot and Ankle Surgery Using Peripheral Nerve Blocks: A Randomized Controlled Trial Comparing Spinal and General Anesthesia as Supplements to Nerve Blocks. Anesth Analg. 2018 Sep;127(3):759-766. doi: 10.1213/ANE.0000000000003456.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 14, 2016)
36
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2017
Actual Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 18-75 aged patients
  • American Society of Anesthesiologists (ASA) Physical Status classification 1-3
  • Elective foot and ankle day surgery procedures, lasting between 1 and 3 hours as per surgeon, performed by 3 co-investigator surgeons.
  • Planned for combined popliteal and adductor canal block
  • No contraindications for spinal or LMA general anesthesia

Exclusion Criteria:

  • Incapable of providing informed consent
  • Contraindications for regional or LMA anesthesia (anticoagulation, infection at injection site)
  • Anticipated difficult airway
  • BMI>40
  • Anticipated surgical procedure time less than 1 hour or more than 3 hours
  • Hx of severe postoperative nausea and vomiting
  • ASA >3
  • Peripheral neuropathy affecting the operative extremity
  • Pregnant or nursing women
  • Chronic opioid use (daily use of opioids one month prior to surgery/ patients requiring chronic pain interventions)
  • Prone position
  • Obstructive sleep apnea with planned admission overnight to the hospital
  • Known allergy/sensitivity to any study medications
  • Planned admission after surgery
  • Non-English speaking
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02996591
Other Study ID Numbers  ICMJE 2016-0499
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hospital for Special Surgery, New York
Study Sponsor  ICMJE Hospital for Special Surgery, New York
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jacques YaDeau, MD Hospital for Special Surgery, New York
PRS Account Hospital for Special Surgery, New York
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP