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

Browse trials for

• Nausea 822
• Vomiting 1,100
• Postoperative Nausea and Vomiting 609

Keywords

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

Nausea

822 studies on the registry are indexed under Nausea; 104 are open to participants now.

This study's enrollment of 36 is below the median of 115 across 703 interventional studies indexed under Nausea.

Lead sponsor

Hospital for Special Surgery, New York is the lead sponsor of 217 studies on the registry; 39 are open to participants now.

Of its 27 completed or terminated interventional studies of FDA-regulated products, 20 (74%) have results posted.

Study arms

• 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.

  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.

  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

Interventions

• Procedure25 mL of 0.25% bupivacaine plus 2 mg preservative-free (PF) dexamethasone / 30 ml for popliteal nerve block
• Procedure10 mL of 0.25% bupivacaine plus 2 mg preservative-free (PF) dexamethasone / 30 ml for adductor canal nerve block
• DrugMidazolam, 2-5 mg IV + Glycopyrrolate, 0.1 mg IV + Ketamine, 10-20 mg + propofol as needed
• Procedure45-60 mg of 1.5% mepivacaine for spinal anesthesia
• ProcedureLMA insertion + titrated propofol infusion + sevoflurane + ketamine 10 mg/hr for general anesthesia

Primary outcomes

1. Time Until Patient is Ready for Discharge From Post-Anesthesia Care Unit (PACU) to Home.

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

   Time frame: Duration of stay in recovery room after surgery

Secondary outcomes

1. Numerical Rating Scale (NRS) Pain Scores at 1 Hour Postop

   NRS Pain scores at 1 hour after surgery. Rated on a scale of 0 (no pain) to 10 (worst pain imaginable).

   Time frame: 1 hour after PACU admission

2. Numerical Rating Scale Pain Scores at 2 Hours Postop

   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).

   Time frame: 2 hours after PACU admission

3. Numerical Rating Scale Pain Scores on Postoperative Day (POD) 1

   Numerical Rating Scale Pain from 0-10. 0 being no pain at all. 10 being the worst pain imaginable.

   Time frame: 24 hours after surgery

4. Postoperative Discomfort and Needs (Post-op Pain, Sore Throat, Back Pain, Nausea, Cold, Hunger, Thirst)

   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.

   Time frame: 1 hour after surgery

5. Postoperative Discomfort and Needs (Post-op Pain, Sore Throat, Back Pain, Nausea, Cold, Hunger, Thirst)

   Rating the Nausea/Vomiting of patients post-operatively.

   Time frame: 2 hours after surgery

6. Postoperative Discomfort and Needs (Post-op Pain, Sore Throat, Back Pain, Nausea, Cold, Hunger, Thirst)

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

   Time frame: Postoperative day 1

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

   Opioid consumption (mg OME) during inpatient stay

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

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

    Time frame: Postoperative day 1

11. Non-opioid Analgesic Consumption

    The number of patients who took non-opioid analgesic medication for post-operative pain between hospital discharge and postoperative day 1.

    Time frame: Hospital discharge to postoperative day 1

12. Opioid-Related Symptom Distress Scale (ORSDS) Score

    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.

    Time frame: 2 hours after surgery

13. Cognitive Recovery

    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)

    Time frame: 1 hour after surgery

14. Incidence of Urinary Catheterization

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

15. Anesthesia-related Postoperative Complications

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

    Time frame: Surgery start to postoperative day 1

16. Assessment of Patient Blinding to Group Assignment

    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.

    Time frame: Postoperative day 1

17. Patient Satisfaction

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

    Time frame: POD1

18. Cognitive Recovery at 2 Hours Post-operative

    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)

    Time frame: 2 hours after PACU admission

19. Cognitive Recovery on POD1

    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)

    Time frame: Postoperative day 1

20. Nausea Intensity

    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.

    Time frame: 2 hours after PACU admission

21. Back Pain on POD1

    Back pain (yes/no) on POD1

    Time frame: Postoperative day 1

Baseline characteristics

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. PubMed 29847387 ↗

Study documents

• Informed consent form · Dec 19, 2016
• Protocol and statistical analysis plan · Jan 18, 2017

Documents are hosted by the registry — open the source record to download them.