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

Phase 4

Completed

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

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

Registration Number: NCT02996591

Lead Sponsor: Hospital for Special Surgery, New York

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 available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 36

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Spinal anesthesia with popliteal and adductor canal blocks.	10 mL of 0.25% bupivacaine plus 2 mg preservative-free (PF) dexamethasone / 30 ml for adductor canal nerve block	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.
Spinal anesthesia with popliteal and adductor canal blocks.	Midazolam, 2-5 mg IV + Glycopyrrolate, 0.1 mg IV + Ketamine, 10-20 mg + propofol as needed	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.
General anesthesia with popliteal and adductor canal blocks.	25 mL of 0.25% bupivacaine plus 2 mg preservative-free (PF) dexamethasone / 30 ml for popliteal nerve block	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.
Spinal anesthesia with popliteal and adductor canal blocks.	25 mL of 0.25% bupivacaine plus 2 mg preservative-free (PF) dexamethasone / 30 ml for popliteal nerve block	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.
Spinal anesthesia with popliteal and adductor canal blocks.	45-60 mg of 1.5% mepivacaine for spinal anesthesia	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.
General anesthesia with popliteal and adductor canal blocks.	Midazolam, 2-5 mg IV + Glycopyrrolate, 0.1 mg IV + Ketamine, 10-20 mg + propofol as needed	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.
General anesthesia with popliteal and adductor canal blocks.	LMA insertion + titrated propofol infusion + sevoflurane + ketamine 10 mg/hr for general anesthesia	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.
General anesthesia with popliteal and adductor canal blocks.	10 mL of 0.25% bupivacaine plus 2 mg preservative-free (PF) dexamethasone / 30 ml for adductor canal nerve block	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.

Primary Outcome Measures

Name	Time	Method
Time Until Patient is Ready for Discharge From Post-Anesthesia Care Unit (PACU) to Home.	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 Outcome Measures

Name	Time	Method
Numerical Rating Scale (NRS) Pain Scores at 1 Hour Postop	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 on Postoperative Day (POD) 1	24 hours after surgery	Numerical Rating Scale Pain from 0-10. 0 being no pain at all. 10 being the worst pain imaginable.
Opioid-Related Symptom Distress Scale (ORSDS) Score	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.
Incidence of Transient Neurologic Symptoms	Postoperative day 1 and if present, monitored until resolution
Opioid Consumption	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	Postoperative day 1
Non-opioid Analgesic Consumption	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.
Anesthesia-related Postoperative Complications	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	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.
Cognitive Recovery at 2 Hours Post-operative	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)
Incidence of Urinary Catheterization	Duration of stay in recovery room after surgery (average 2 hours)
Postoperative Discomfort and Needs (Post-op Pain, Sore Throat, Back Pain, Nausea, Cold, Hunger, Thirst)	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	Postoperative day 1 and if present, monitored until resolution
Numerical Rating Scale Pain Scores at 2 Hours Postop	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).
Cognitive Recovery	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)
Patient Satisfaction	POD1	Yes/no if patients would request the same anesthetic that they received
Cognitive Recovery on POD1	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	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	Postoperative day 1	Back pain (yes/no) on POD1