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NCT Number: NCT02996591

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

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.

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Key information

Conditions

Nerve Block General Anesthesia Nausea Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Nausea and Vomiting Signs and Symptoms Signs and Symptoms, Digestive Spinal Anesthesia Vomiting

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital for Special Surgery, New York

New York, 10021, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Procedure

Midazolam, 2-5 mg IV + Glycopyrrolate, 0.1 mg IV + Ketamine, 10-20 mg + propofol as needed

Drug

45-60 mg of 1.5% mepivacaine for spinal anesthesia

Procedure

LMA insertion + titrated propofol infusion + sevoflurane + ketamine 10 mg/hr for general anesthesia

Procedure

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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).

  2. 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).

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. Incidence of Post-dural Puncture Headache

    Time frame: Postoperative day 1 and if present, monitored until resolution

  8. Incidence of Transient Neurologic Symptoms

    Time frame: Postoperative day 1 and if present, monitored until resolution

  9. Opioid Consumption

    Time frame: Duration of stay in recovery room after surgery (average 2 hours)

    Opioid consumption (mg OME) during inpatient stay

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

    Time frame: Postoperative day 1

  11. 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.

  12. 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.

  13. 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)

  14. Incidence of Urinary Catheterization

    Time frame: Duration of stay in recovery room after surgery (average 2 hours)

  15. Anesthesia-related Postoperative Complications

    Time frame: Surgery start to postoperative day 1

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

  16. 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.

  17. Patient Satisfaction

    Time frame: POD1

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

  18. 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)

  19. 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)

  20. 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.

  21. Back Pain on POD1

    Time frame: Postoperative day 1

    Back pain (yes/no) on POD1

Sponsors and collaborators

Lead sponsor

Hospital for Special Surgery, New York

Other

Registry information

Official study title

Spinal Versus General Anesthesia With Popliteal and Adductor Canal Blocks for Ambulatory Foot and Ankle Surgery: A Double-Blinded Randomized Controlled Trial.

Acronym: LMA vs Spinal

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Dec 19, 2016
Registry last updated
Nov 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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