General Anesthesia, Nerve Block, Pain, Postoperative Nausea and Vomiting, Spinal Anesthesia
Conditions
Keywords
Nerve Block, General Anesthesia, Spinal Anesthesia, Pain, Postoperative Nausea and Vomiting
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.
Interventions
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
PROCEDURE25 mL of 0.25% bupivacaine plus 2 mg preservative-free (PF) dexamethasone / 30 ml for popliteal nerve block
Sponsors
Hospital for Special Surgery, New York
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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. |
| Postoperative Discomfort and Needs (Post-op Pain, Sore Throat, Back Pain, Nausea, Cold, Hunger, Thirst) | 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. |
| 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 | 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. |
| 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. |
| 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). |
| Incidence of Urinary Catheterization | Duration of stay in recovery room after surgery (average 2 hours) | — |
| 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. |
| Patient Satisfaction | POD1 | Yes/no if patients would request the same anesthetic that they received |
| 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) |
| 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 |
| 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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: 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.
25 mL of 0.25% bupivacaine plus 2 mg preservative-free (PF) dexamethasone / 30 ml for popliteal nerve block
10 mL of 0.25% bupivacaine plus 2 mg preservative-free (PF) dexamethasone / 30 ml for adductor canal nerve block
Midazolam, 2-5 mg IV + Glycopyrrolate, 0.1 mg IV + Ketamine, 10-20 mg + propofol as needed
45-60 mg of 1.5% mepivacaine for | 18 |
| 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.
25 mL of 0.25% bupivacaine plus 2 mg preservative-free (PF) dexamethasone / 30 ml for popliteal nerve block
10 mL of 0.25% bupivacaine plus 2 mg preservative-free (PF) dexamethasone / 30 ml for adductor canal nerve block
Midazolam, 2-5 mg IV + Glycopyrrolate, 0.1 mg IV + Ketamine, 10-20 mg + propofol as needed
LMA insertion + titrated propofol infusion + sevoflurane + ketamine 10 mg/hr for general anesthesia | 18 |
| Total | 36 |
Baseline characteristics
| Characteristic | Spinal Anesthesia With Popliteal and Adductor Canal Blocks. | General Anesthesia With Popliteal and Adductor Canal Blocks. | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 0 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants | 18 Participants | 32 Participants |
| Age, Continuous | 55 years STANDARD_DEVIATION 13 | 47 years STANDARD_DEVIATION 11 | 51 years STANDARD_DEVIATION 12 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 16 Participants | 17 Participants | 33 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) White | 17 Participants | 16 Participants | 33 Participants |
| Region of Enrollment United States | 18 Participants | 18 Participants | 36 Participants |
| Sex: Female, Male Female | 13 Participants | 13 Participants | 26 Participants |
| Sex: Female, Male Male | 5 Participants | 5 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 18 |
| other Total, other adverse events | 0 / 18 | 0 / 18 |
| serious Total, serious adverse events | 0 / 18 | 0 / 18 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Spinal Anesthesia With Popliteal and Adductor Canal Blocks. | Time Until Patient is Ready for Discharge From Post-Anesthesia Care Unit (PACU) to Home. | 81 Minutes |
| General Anesthesia With Popliteal and Adductor Canal Blocks. | Time Until Patient is Ready for Discharge From Post-Anesthesia Care Unit (PACU) to Home. | 43.5 Minutes |
Secondary
Anesthesia-related Postoperative Complications
Measuring any anesthesia-related post-op complications that occured (yes or no)
Time frame: Surgery start to postoperative day 1
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Spinal Anesthesia With Popliteal and Adductor Canal Blocks. | Anesthesia-related Postoperative Complications | Yes | 0 Participants |
| Spinal Anesthesia With Popliteal and Adductor Canal Blocks. | Anesthesia-related Postoperative Complications | No | 18 Participants |
| General Anesthesia With Popliteal and Adductor Canal Blocks. | Anesthesia-related Postoperative Complications | Yes | 0 Participants |
| General Anesthesia With Popliteal and Adductor Canal Blocks. | Anesthesia-related Postoperative Complications | No | 18 Participants |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Spinal Anesthesia With Popliteal and Adductor Canal Blocks. | Assessment of Patient Blinding to Group Assignment | .588 Bang blinding index |
| General Anesthesia With Popliteal and Adductor Canal Blocks. | Assessment of Patient Blinding to Group Assignment | .722 Bang blinding index |
p-value: 0.038Regression, Logistic
p-value: <0.001Bang Blinding Index
Secondary
Back Pain on POD1
Back pain (yes/no) on POD1
Time frame: Postoperative day 1
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Spinal Anesthesia With Popliteal and Adductor Canal Blocks. | Back Pain on POD1 | No | 16 Participants |
| Spinal Anesthesia With Popliteal and Adductor Canal Blocks. | Back Pain on POD1 | Yes | 2 Participants |
| General Anesthesia With Popliteal and Adductor Canal Blocks. | Back Pain on POD1 | No | 14 Participants |
| General Anesthesia With Popliteal and Adductor Canal Blocks. | Back Pain on POD1 | Yes | 3 Participants |
Secondary
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Spinal Anesthesia With Popliteal and Adductor Canal Blocks. | Cognitive Recovery | No | 3 Participants |
| Spinal Anesthesia With Popliteal and Adductor Canal Blocks. | Cognitive Recovery | Yes | 14 Participants |
| General Anesthesia With Popliteal and Adductor Canal Blocks. | Cognitive Recovery | No | 4 Participants |
| General Anesthesia With Popliteal and Adductor Canal Blocks. | Cognitive Recovery | Yes | 13 Participants |
Secondary
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Spinal Anesthesia With Popliteal and Adductor Canal Blocks. | Cognitive Recovery at 2 Hours Post-operative | No | 1 Participants |
| Spinal Anesthesia With Popliteal and Adductor Canal Blocks. | Cognitive Recovery at 2 Hours Post-operative | Yes | 16 Participants |
| General Anesthesia With Popliteal and Adductor Canal Blocks. | Cognitive Recovery at 2 Hours Post-operative | No | 4 Participants |
| General Anesthesia With Popliteal and Adductor Canal Blocks. | Cognitive Recovery at 2 Hours Post-operative | Yes | 13 Participants |
Secondary
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Spinal Anesthesia With Popliteal and Adductor Canal Blocks. | Cognitive Recovery on POD1 | No | 3 Participants |
| Spinal Anesthesia With Popliteal and Adductor Canal Blocks. | Cognitive Recovery on POD1 | Yes | 14 Participants |
| General Anesthesia With Popliteal and Adductor Canal Blocks. | Cognitive Recovery on POD1 | No | 2 Participants |
| General Anesthesia With Popliteal and Adductor Canal Blocks. | Cognitive Recovery on POD1 | Yes | 15 Participants |
Secondary
Incidence of Post-dural Puncture Headache
Time frame: Postoperative day 1 and if present, monitored until resolution
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Spinal Anesthesia With Popliteal and Adductor Canal Blocks. | Incidence of Post-dural Puncture Headache | Yes | 4 Participants |
| Spinal Anesthesia With Popliteal and Adductor Canal Blocks. | Incidence of Post-dural Puncture Headache | No | 14 Participants |
| General Anesthesia With Popliteal and Adductor Canal Blocks. | Incidence of Post-dural Puncture Headache | Yes | 3 Participants |
| General Anesthesia With Popliteal and Adductor Canal Blocks. | Incidence of Post-dural Puncture Headache | No | 14 Participants |
Secondary
Incidence of Transient Neurologic Symptoms
Time frame: Postoperative day 1 and if present, monitored until resolution
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Spinal Anesthesia With Popliteal and Adductor Canal Blocks. | Incidence of Transient Neurologic Symptoms | Normal | 18 Participants |
| Spinal Anesthesia With Popliteal and Adductor Canal Blocks. | Incidence of Transient Neurologic Symptoms | Transient Neurological Symptoms | 0 Participants |
| General Anesthesia With Popliteal and Adductor Canal Blocks. | Incidence of Transient Neurologic Symptoms | Normal | 18 Participants |
| General Anesthesia With Popliteal and Adductor Canal Blocks. | Incidence of Transient Neurologic Symptoms | Transient Neurological Symptoms | 0 Participants |
Secondary
Incidence of Urinary Catheterization
Time frame: Duration of stay in recovery room after surgery (average 2 hours)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Spinal Anesthesia With Popliteal and Adductor Canal Blocks. | Incidence of Urinary Catheterization | Yes | 0 Participants |
| Spinal Anesthesia With Popliteal and Adductor Canal Blocks. | Incidence of Urinary Catheterization | No | 18 Participants |
| General Anesthesia With Popliteal and Adductor Canal Blocks. | Incidence of Urinary Catheterization | Yes | 0 Participants |
| General Anesthesia With Popliteal and Adductor Canal Blocks. | Incidence of Urinary Catheterization | No | 18 Participants |
Secondary
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Spinal Anesthesia With Popliteal and Adductor Canal Blocks. | Nausea Intensity | 0 score on a scale |
| General Anesthesia With Popliteal and Adductor Canal Blocks. | Nausea Intensity | 0 score on a scale |
Secondary
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Spinal Anesthesia With Popliteal and Adductor Canal Blocks. | Non-opioid Analgesic Consumption | yes | 12 Participants |
| Spinal Anesthesia With Popliteal and Adductor Canal Blocks. | Non-opioid Analgesic Consumption | No | 6 Participants |
| General Anesthesia With Popliteal and Adductor Canal Blocks. | Non-opioid Analgesic Consumption | yes | 12 Participants |
| General Anesthesia With Popliteal and Adductor Canal Blocks. | Non-opioid Analgesic Consumption | No | 5 Participants |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Spinal Anesthesia With Popliteal and Adductor Canal Blocks. | Numerical Rating Scale (NRS) Pain Scores at 1 Hour Postop | 0 units on a scale | Standard Deviation 0 |
| General Anesthesia With Popliteal and Adductor Canal Blocks. | Numerical Rating Scale (NRS) Pain Scores at 1 Hour Postop | 1.8 units on a scale | Standard Deviation 2.1 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Spinal Anesthesia With Popliteal and Adductor Canal Blocks. | Numerical Rating Scale Pain Scores at 2 Hours Postop | .4 units on a scale | Standard Deviation 1.3 |
| General Anesthesia With Popliteal and Adductor Canal Blocks. | Numerical Rating Scale Pain Scores at 2 Hours Postop | .9 units on a scale | Standard Deviation 1.6 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Spinal Anesthesia With Popliteal and Adductor Canal Blocks. | Numerical Rating Scale Pain Scores on Postoperative Day (POD) 1 | 1 score on a scale | Standard Deviation 1.6 |
| General Anesthesia With Popliteal and Adductor Canal Blocks. | Numerical Rating Scale Pain Scores on Postoperative Day (POD) 1 | 1 score on a scale | Standard Deviation 1.7 |
Secondary
Opioid Consumption
Opioid consumption (mg OME) during inpatient stay
Time frame: Duration of stay in recovery room after surgery (average 2 hours)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Spinal Anesthesia With Popliteal and Adductor Canal Blocks. | Opioid Consumption | 2.2 mg OME | Standard Deviation 7.3 |
| General Anesthesia With Popliteal and Adductor Canal Blocks. | Opioid Consumption | 5 mg OME | Standard Deviation 7 |
Secondary
Opioid Consumption Through First Postoperative Day. Measured in mg OME
Time frame: Postoperative day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Spinal Anesthesia With Popliteal and Adductor Canal Blocks. | Opioid Consumption Through First Postoperative Day. Measured in mg OME | 8.3 mg OME | Standard Deviation 10.3 |
| General Anesthesia With Popliteal and Adductor Canal Blocks. | Opioid Consumption Through First Postoperative Day. Measured in mg OME | 11 mg OME | Standard Deviation 12.3 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Spinal Anesthesia With Popliteal and Adductor Canal Blocks. | Opioid-Related Symptom Distress Scale (ORSDS) Score | .3 units on a scale | Standard Deviation 0.2 |
| General Anesthesia With Popliteal and Adductor Canal Blocks. | Opioid-Related Symptom Distress Scale (ORSDS) Score | .3 units on a scale | Standard Deviation 0.3 |
Secondary
Patient Satisfaction
Yes/no if patients would request the same anesthetic that they received
Time frame: POD1
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Spinal Anesthesia With Popliteal and Adductor Canal Blocks. | Patient Satisfaction | Yes | 18 Participants |
| Spinal Anesthesia With Popliteal and Adductor Canal Blocks. | Patient Satisfaction | No | 0 Participants |
| General Anesthesia With Popliteal and Adductor Canal Blocks. | Patient Satisfaction | Yes | 17 Participants |
| General Anesthesia With Popliteal and Adductor Canal Blocks. | Patient Satisfaction | No | 0 Participants |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Spinal Anesthesia With Popliteal and Adductor Canal Blocks. | Postoperative Discomfort and Needs (Post-op Pain, Sore Throat, Back Pain, Nausea, Cold, Hunger, Thirst) | Back Pain | 1.1 score on a scale | Standard Deviation 0.3 |
| Spinal Anesthesia With Popliteal and Adductor Canal Blocks. | Postoperative Discomfort and Needs (Post-op Pain, Sore Throat, Back Pain, Nausea, Cold, Hunger, Thirst) | Cold | 1.3 score on a scale | Standard Deviation 0.6 |
| Spinal Anesthesia With Popliteal and Adductor Canal Blocks. | Postoperative Discomfort and Needs (Post-op Pain, Sore Throat, Back Pain, Nausea, Cold, Hunger, Thirst) | Sore Throat | 1.2 score on a scale | Standard Deviation 0.4 |
| Spinal Anesthesia With Popliteal and Adductor Canal Blocks. | Postoperative Discomfort and Needs (Post-op Pain, Sore Throat, Back Pain, Nausea, Cold, Hunger, Thirst) | Hunger | 1.4 score on a scale | Standard Deviation 0.7 |
| Spinal Anesthesia With Popliteal and Adductor Canal Blocks. | Postoperative Discomfort and Needs (Post-op Pain, Sore Throat, Back Pain, Nausea, Cold, Hunger, Thirst) | Vomiting | 1 score on a scale | Standard Deviation 0 |
| Spinal Anesthesia With Popliteal and Adductor Canal Blocks. | Postoperative Discomfort and Needs (Post-op Pain, Sore Throat, Back Pain, Nausea, Cold, Hunger, Thirst) | Thirst | 2.3 score on a scale | Standard Deviation 1 |
| Spinal Anesthesia With Popliteal and Adductor Canal Blocks. | Postoperative Discomfort and Needs (Post-op Pain, Sore Throat, Back Pain, Nausea, Cold, Hunger, Thirst) | Pain | 1.4 score on a scale | Standard Deviation 0.7 |
| General Anesthesia With Popliteal and Adductor Canal Blocks. | Postoperative Discomfort and Needs (Post-op Pain, Sore Throat, Back Pain, Nausea, Cold, Hunger, Thirst) | Thirst | 2.2 score on a scale | Standard Deviation 1 |
| General Anesthesia With Popliteal and Adductor Canal Blocks. | Postoperative Discomfort and Needs (Post-op Pain, Sore Throat, Back Pain, Nausea, Cold, Hunger, Thirst) | Pain | 1.5 score on a scale | Standard Deviation 0.6 |
| General Anesthesia With Popliteal and Adductor Canal Blocks. | Postoperative Discomfort and Needs (Post-op Pain, Sore Throat, Back Pain, Nausea, Cold, Hunger, Thirst) | Sore Throat | 1.5 score on a scale | Standard Deviation 0.6 |
| General Anesthesia With Popliteal and Adductor Canal Blocks. | Postoperative Discomfort and Needs (Post-op Pain, Sore Throat, Back Pain, Nausea, Cold, Hunger, Thirst) | Back Pain | 1.2 score on a scale | Standard Deviation 0.6 |
| General Anesthesia With Popliteal and Adductor Canal Blocks. | Postoperative Discomfort and Needs (Post-op Pain, Sore Throat, Back Pain, Nausea, Cold, Hunger, Thirst) | Vomiting | 1 score on a scale | Standard Deviation 0 |
| General Anesthesia With Popliteal and Adductor Canal Blocks. | Postoperative Discomfort and Needs (Post-op Pain, Sore Throat, Back Pain, Nausea, Cold, Hunger, Thirst) | Cold | 1 score on a scale | Standard Deviation 0 |
| General Anesthesia With Popliteal and Adductor Canal Blocks. | Postoperative Discomfort and Needs (Post-op Pain, Sore Throat, Back Pain, Nausea, Cold, Hunger, Thirst) | Hunger | 1.7 score on a scale | Standard Deviation 0.7 |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Spinal Anesthesia With Popliteal and Adductor Canal Blocks. | Postoperative Discomfort and Needs (Post-op Pain, Sore Throat, Back Pain, Nausea, Cold, Hunger, Thirst) | Back Pain | 1.1 score on a scale | Standard Deviation 0.2 |
| Spinal Anesthesia With Popliteal and Adductor Canal Blocks. | Postoperative Discomfort and Needs (Post-op Pain, Sore Throat, Back Pain, Nausea, Cold, Hunger, Thirst) | Cold | 1.1 score on a scale | Standard Deviation 0.3 |
| Spinal Anesthesia With Popliteal and Adductor Canal Blocks. | Postoperative Discomfort and Needs (Post-op Pain, Sore Throat, Back Pain, Nausea, Cold, Hunger, Thirst) | Sore Throat | 1.2 score on a scale | Standard Deviation 0.4 |
| Spinal Anesthesia With Popliteal and Adductor Canal Blocks. | Postoperative Discomfort and Needs (Post-op Pain, Sore Throat, Back Pain, Nausea, Cold, Hunger, Thirst) | Hunger | 1.4 score on a scale | Standard Deviation 0.7 |
| Spinal Anesthesia With Popliteal and Adductor Canal Blocks. | Postoperative Discomfort and Needs (Post-op Pain, Sore Throat, Back Pain, Nausea, Cold, Hunger, Thirst) | Vomiting | 1 score on a scale | Standard Deviation 0 |
| Spinal Anesthesia With Popliteal and Adductor Canal Blocks. | Postoperative Discomfort and Needs (Post-op Pain, Sore Throat, Back Pain, Nausea, Cold, Hunger, Thirst) | Thirst | 2.1 score on a scale | Standard Deviation 1.2 |
| Spinal Anesthesia With Popliteal and Adductor Canal Blocks. | Postoperative Discomfort and Needs (Post-op Pain, Sore Throat, Back Pain, Nausea, Cold, Hunger, Thirst) | Pain | 1.2 score on a scale | Standard Deviation 0.5 |
| General Anesthesia With Popliteal and Adductor Canal Blocks. | Postoperative Discomfort and Needs (Post-op Pain, Sore Throat, Back Pain, Nausea, Cold, Hunger, Thirst) | Thirst | 1.8 score on a scale | Standard Deviation 1.2 |
| General Anesthesia With Popliteal and Adductor Canal Blocks. | Postoperative Discomfort and Needs (Post-op Pain, Sore Throat, Back Pain, Nausea, Cold, Hunger, Thirst) | Pain | 1.4 score on a scale | Standard Deviation 0.7 |
| General Anesthesia With Popliteal and Adductor Canal Blocks. | Postoperative Discomfort and Needs (Post-op Pain, Sore Throat, Back Pain, Nausea, Cold, Hunger, Thirst) | Sore Throat | 1.6 score on a scale | Standard Deviation 1.1 |
| General Anesthesia With Popliteal and Adductor Canal Blocks. | Postoperative Discomfort and Needs (Post-op Pain, Sore Throat, Back Pain, Nausea, Cold, Hunger, Thirst) | Back Pain | 1.2 score on a scale | Standard Deviation 0.5 |
| General Anesthesia With Popliteal and Adductor Canal Blocks. | Postoperative Discomfort and Needs (Post-op Pain, Sore Throat, Back Pain, Nausea, Cold, Hunger, Thirst) | Vomiting | 1 score on a scale | Standard Deviation 0 |
| General Anesthesia With Popliteal and Adductor Canal Blocks. | Postoperative Discomfort and Needs (Post-op Pain, Sore Throat, Back Pain, Nausea, Cold, Hunger, Thirst) | Cold | 1.1 score on a scale | Standard Deviation 0.2 |
| General Anesthesia With Popliteal and Adductor Canal Blocks. | Postoperative Discomfort and Needs (Post-op Pain, Sore Throat, Back Pain, Nausea, Cold, Hunger, Thirst) | Hunger | 1.2 score on a scale | Standard Deviation 0.5 |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Spinal Anesthesia With Popliteal and Adductor Canal Blocks. | Postoperative Discomfort and Needs (Post-op Pain, Sore Throat, Back Pain, Nausea, Cold, Hunger, Thirst) | Back Pain | 1.2 score on a scale | Standard Deviation 0.5 |
| Spinal Anesthesia With Popliteal and Adductor Canal Blocks. | Postoperative Discomfort and Needs (Post-op Pain, Sore Throat, Back Pain, Nausea, Cold, Hunger, Thirst) | Cold | 1.4 score on a scale | Standard Deviation 0.8 |
| Spinal Anesthesia With Popliteal and Adductor Canal Blocks. | Postoperative Discomfort and Needs (Post-op Pain, Sore Throat, Back Pain, Nausea, Cold, Hunger, Thirst) | A Sore Throat | 1.2 score on a scale | Standard Deviation 0.5 |
| Spinal Anesthesia With Popliteal and Adductor Canal Blocks. | Postoperative Discomfort and Needs (Post-op Pain, Sore Throat, Back Pain, Nausea, Cold, Hunger, Thirst) | Hunger | 1.9 score on a scale | Standard Deviation 1.2 |
| Spinal Anesthesia With Popliteal and Adductor Canal Blocks. | Postoperative Discomfort and Needs (Post-op Pain, Sore Throat, Back Pain, Nausea, Cold, Hunger, Thirst) | Vomiting | 1 score on a scale | Standard Deviation 0 |
| Spinal Anesthesia With Popliteal and Adductor Canal Blocks. | Postoperative Discomfort and Needs (Post-op Pain, Sore Throat, Back Pain, Nausea, Cold, Hunger, Thirst) | Thirst | 2.7 score on a scale | Standard Deviation 1.2 |
| Spinal Anesthesia With Popliteal and Adductor Canal Blocks. | Postoperative Discomfort and Needs (Post-op Pain, Sore Throat, Back Pain, Nausea, Cold, Hunger, Thirst) | Pain | 1.1 score on a scale | Standard Deviation 0.5 |
| General Anesthesia With Popliteal and Adductor Canal Blocks. | Postoperative Discomfort and Needs (Post-op Pain, Sore Throat, Back Pain, Nausea, Cold, Hunger, Thirst) | Thirst | 2.5 score on a scale | Standard Deviation 1.2 |
| General Anesthesia With Popliteal and Adductor Canal Blocks. | Postoperative Discomfort and Needs (Post-op Pain, Sore Throat, Back Pain, Nausea, Cold, Hunger, Thirst) | Pain | 1.6 score on a scale | Standard Deviation 0.8 |
| General Anesthesia With Popliteal and Adductor Canal Blocks. | Postoperative Discomfort and Needs (Post-op Pain, Sore Throat, Back Pain, Nausea, Cold, Hunger, Thirst) | A Sore Throat | 1.6 score on a scale | Standard Deviation 1.1 |
| General Anesthesia With Popliteal and Adductor Canal Blocks. | Postoperative Discomfort and Needs (Post-op Pain, Sore Throat, Back Pain, Nausea, Cold, Hunger, Thirst) | Back Pain | 1.2 score on a scale | Standard Deviation 0.5 |
| General Anesthesia With Popliteal and Adductor Canal Blocks. | Postoperative Discomfort and Needs (Post-op Pain, Sore Throat, Back Pain, Nausea, Cold, Hunger, Thirst) | Vomiting | 1 score on a scale | Standard Deviation 0 |
| General Anesthesia With Popliteal and Adductor Canal Blocks. | Postoperative Discomfort and Needs (Post-op Pain, Sore Throat, Back Pain, Nausea, Cold, Hunger, Thirst) | Cold | 1.3 score on a scale | Standard Deviation 0.6 |
| General Anesthesia With Popliteal and Adductor Canal Blocks. | Postoperative Discomfort and Needs (Post-op Pain, Sore Throat, Back Pain, Nausea, Cold, Hunger, Thirst) | Hunger | 1.7 score on a scale | Standard Deviation 0.9 |