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

Ketamine

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.

Intervention / Treatment

  • 25 mL of 0.25% bupivacaine plus 2 mg preservative-free (PF) dexamethasone / 30 ml for popliteal nerve block (PROCEDURE)
    N/A
  • 10 mL of 0.25% bupivacaine plus 2 mg preservative-free (PF) dexamethasone / 30 ml for adductor canal nerve block (PROCEDURE)
    N/A
  • Midazolam, 2-5 mg IV + Glycopyrrolate, 0.1 mg IV + Ketamine, 10-20 mg + propofol as needed (DRUG)
    N/A
  • 45-60 mg of 1.5% mepivacaine for spinal anesthesia (PROCEDURE)
    N/A
  • LMA insertion + titrated propofol infusion + sevoflurane + ketamine 10 mg/hr for general anesthesia (PROCEDURE)
    N/A

Condition or Disease

  • Nerve Block
  • General Anesthesia
  • Spinal Anesthesia
  • Pain
  • Postoperative Nausea and Vomiting

Phase

  • Phase 4

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 18 Years to 75 Years
    Enrollment: 36 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    DOUBLE:
    • Participant
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Jan 01, 2017 ACTUAL
    Primary Completion: May 01, 2017 ACTUAL
    Completion Date: May 01, 2017 ACTUAL
    Study First Posted: Dec 19, 2016 ESTIMATED
    Results First Posted: Nov 12, 2019 ACTUAL
    Last Updated: Nov 07, 2019

    Sponsors / Collaborators

    Lead Sponsor: Hospital for Special Surgery, New York
    Lead sponsor is responsible party
    Responsible Party: N/A

    Location

    New York, New York, USA

    Participant Groups

    • 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.

    • 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.

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Maximum Age: 75
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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

    Primary Outcomes

    • Modified Aldrete Scoring System and Marshall and Chung Postanesthesia Discharge Scoring System, measured in time until discharge criteria is met (in minutes)

    Secondary Outcomes

    • 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 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 from 0-10. 0 being no pain at all. 10 being the worst pain imaginable.

    • 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.

    • Rating the Nausea/Vomiting of patients post-operatively.

    • Leiden Perioperative Care Patient Satisfaction questionnaire (LPPSq). From 1-5. 1 being not at all. 5 being extremely.

    • Incidence of Post-dural Puncture Headache Postoperative day 1 and if present, monitored until resolution
    • Incidence of Transient Neurologic Symptoms Postoperative day 1 and if present, monitored until resolution

    • Opioid consumption (mg OME) during inpatient stay

    • Opioid Consumption Through First Postoperative Day. Measured in mg OME 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. 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.

    • 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 Duration of stay in recovery room after surgery (average 2 hours)

    • Measuring any anesthesia-related post-op complications that occured (yes or no)

    • 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.

    • Yes/no if patients would request the same anesthetic that they received

    • 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)

    • 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 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 (yes/no) on POD1

    More Details

    NCT Number: NCT02996591
    Acronym: LMA vs Spinal
    Other IDs: 2016-0499
    Study URL: https://clinicaltrials.gov/study/NCT02996591
    Last updated: Sep 29, 2023