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

Study Overview
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Brief Summary
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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.

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

Conditions
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Nerve Block, General Anesthesia, Spinal Anesthesia, Pain, Postoperative Nausea and Vomiting

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Spinal anesthesia with popliteal and adductor canal blocks.<br>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<br> <br> Procedure: 10 mL of 0.25% bupivacaine plus 2 mg preservative-free (PF) dexamethasone / 30 ml for adductor canal nerve block<br> <br> Drug: Midazolam, 2-5 mg IV + Glycopyrrolate, 0.1 mg IV + Ketamine, 10-20 mg + propofol as needed<br> <br> Procedure: 45-60 mg of 1.5% mepivacaine for spinal anesthesia<br> <br> |
| Active Comparator: General anesthesia with popliteal and adductor canal blocks.<br>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<br> <br> Procedure: 10 mL of 0.25% bupivacaine plus 2 mg preservative-free (PF) dexamethasone / 30 ml for adductor canal nerve block<br> <br> Drug: Midazolam, 2-5 mg IV + Glycopyrrolate, 0.1 mg IV + Ketamine, 10-20 mg + propofol as needed<br> <br> Procedure: LMA insertion + titrated propofol infusion + sevoflurane + ketamine 10 mg/hr for general anesthesia<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Duration of stay in recovery room after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 1 hour after PACU admission | 
| 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). | 2 hours after PACU admission | 
| 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. | 24 hours after surgery | 
| 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. | 1 hour after surgery | 
| Postoperative Discomfort and Needs (Post-op Pain, Sore Throat, Back Pain, Nausea, Cold, Hunger, Thirst) | Rating the Nausea/Vomiting of patients post-operatively. | 2 hours after surgery | 
| 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. | Postoperative day 1 | 
| 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 | Opioid consumption (mg OME) during inpatient stay | Duration of stay in recovery room after surgery (average 2 hours) | 
| Opioid Consumption Through First Postoperative Day. Measured in mg OME |  | Postoperative day 1 | 
| 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. | Hospital discharge to postoperative day 1 | 
| 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. | 2 hours after surgery | 
| 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) | 1 hour after surgery | 
| Incidence of Urinary Catheterization |  | Duration of stay in recovery room after surgery (average 2 hours) | 
| Anesthesia-related Postoperative Complications | Measuring any anesthesia-related post-op complications that occured (yes or no) | Surgery start to postoperative day 1 | 
| 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. | Postoperative day 1 | 
| Patient Satisfaction | Yes/no if patients would request the same anesthetic that they received | POD1 | 
| 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) | 2 hours after PACU admission | 
| 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) | Postoperative day 1 | 
| 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. | 2 hours after PACU admission | 
| Back Pain on POD1 | Back pain (yes/no) on POD1 | Postoperative day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nerve Block, General Anesthesia, Spinal Anesthesia, Pain, Postoperative Nausea and Vomiting