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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
36
Hospital for Special Surgery, New York
New York, New York, United States
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
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
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
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
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
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
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
Incidence of Post-dural Puncture Headache
Time frame: Postoperative day 1 and if present, monitored until resolution
Incidence of Transient Neurologic Symptoms
Time frame: Postoperative day 1 and if present, monitored until resolution
Opioid Consumption
Opioid consumption (mg OME) during inpatient stay
Time frame: Duration of stay in recovery room after surgery (average 2 hours)
Opioid Consumption Through First Postoperative Day. Measured in mg OME
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 1 hour after surgery
Incidence of Urinary Catheterization
Time frame: 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)
Time frame: 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.
Time frame: Postoperative day 1
Patient Satisfaction
Yes/no if patients would request the same anesthetic that they received
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 2 hours after PACU admission
Back Pain on POD1
Back pain (yes/no) on POD1
Time frame: Postoperative day 1
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