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

Primary Purpose

Nerve Block, General Anesthesia, Spinal Anesthesia

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
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 spinal anesthesia
LMA insertion + titrated propofol infusion + sevoflurane + ketamine 10 mg/hr for general anesthesia
Sponsored by
Hospital for Special Surgery, New York
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nerve Block focused on measuring Nerve Block, General Anesthesia, Spinal Anesthesia, Pain, Postoperative Nausea and Vomiting

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital for Special Surgery, New York

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Spinal anesthesia with popliteal and adductor canal blocks.

General anesthesia with popliteal and adductor canal blocks.

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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).
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).
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.
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.
Postoperative Discomfort and Needs (Post-op Pain, Sore Throat, Back Pain, Nausea, Cold, Hunger, Thirst)
Rating the Nausea/Vomiting of patients post-operatively.
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.
Incidence of Post-dural Puncture Headache
Incidence of Transient Neurologic Symptoms
Opioid Consumption
Opioid consumption (mg OME) during inpatient stay
Opioid Consumption Through First Postoperative Day. Measured in mg OME
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.
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.
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)
Incidence of Urinary Catheterization
Anesthesia-related Postoperative Complications
Measuring any anesthesia-related post-op complications that occured (yes or no)
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.
Patient Satisfaction
Yes/no if patients would request the same anesthetic that they received
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)
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)
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.
Back Pain on POD1
Back pain (yes/no) on POD1

Full Information

First Posted
December 2, 2016
Last Updated
November 7, 2019
Sponsor
Hospital for Special Surgery, New York
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1. Study Identification

Unique Protocol Identification Number
NCT02996591
Brief Title
Spinal Versus General Anesthesia With Popliteal and Adductor Canal Blocks for Ambulatory Foot and Ankle Surgery.
Acronym
LMA vs Spinal
Official Title
Spinal Versus General Anesthesia With Popliteal and Adductor Canal Blocks for Ambulatory Foot and Ankle Surgery: A Double-Blinded Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital for Special Surgery, New York

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nerve Block, General Anesthesia, Spinal Anesthesia, Pain, Postoperative Nausea and Vomiting
Keywords
Nerve Block, General Anesthesia, Spinal Anesthesia, Pain, Postoperative Nausea and Vomiting

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Spinal anesthesia with popliteal and adductor canal blocks.
Arm Type
Active Comparator
Arm Description
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.
Arm Title
General anesthesia with popliteal and adductor canal blocks.
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
25 mL of 0.25% bupivacaine plus 2 mg preservative-free (PF) dexamethasone / 30 ml for popliteal nerve block
Intervention Type
Procedure
Intervention Name(s)
10 mL of 0.25% bupivacaine plus 2 mg preservative-free (PF) dexamethasone / 30 ml for adductor canal nerve block
Intervention Type
Drug
Intervention Name(s)
Midazolam, 2-5 mg IV + Glycopyrrolate, 0.1 mg IV + Ketamine, 10-20 mg + propofol as needed
Intervention Type
Procedure
Intervention Name(s)
45-60 mg of 1.5% mepivacaine for spinal anesthesia
Intervention Type
Procedure
Intervention Name(s)
LMA insertion + titrated propofol infusion + sevoflurane + ketamine 10 mg/hr for general anesthesia
Primary Outcome Measure Information:
Title
Time Until Patient is Ready for Discharge From Post-Anesthesia Care Unit (PACU) to Home.
Description
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 Outcome Measure Information:
Title
Numerical Rating Scale (NRS) Pain Scores at 1 Hour Postop
Description
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
Title
Numerical Rating Scale Pain Scores at 2 Hours Postop
Description
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
Title
Numerical Rating Scale Pain Scores on Postoperative Day (POD) 1
Description
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
Title
Postoperative Discomfort and Needs (Post-op Pain, Sore Throat, Back Pain, Nausea, Cold, Hunger, Thirst)
Description
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
Title
Postoperative Discomfort and Needs (Post-op Pain, Sore Throat, Back Pain, Nausea, Cold, Hunger, Thirst)
Description
Rating the Nausea/Vomiting of patients post-operatively.
Time Frame
2 hours after surgery
Title
Postoperative Discomfort and Needs (Post-op Pain, Sore Throat, Back Pain, Nausea, Cold, Hunger, Thirst)
Description
Leiden Perioperative Care Patient Satisfaction questionnaire (LPPSq). From 1-5. 1 being not at all. 5 being extremely.
Time Frame
Postoperative day 1
Title
Incidence of Post-dural Puncture Headache
Time Frame
Postoperative day 1 and if present, monitored until resolution
Title
Incidence of Transient Neurologic Symptoms
Time Frame
Postoperative day 1 and if present, monitored until resolution
Title
Opioid Consumption
Description
Opioid consumption (mg OME) during inpatient stay
Time Frame
Duration of stay in recovery room after surgery (average 2 hours)
Title
Opioid Consumption Through First Postoperative Day. Measured in mg OME
Time Frame
Postoperative day 1
Title
Non-opioid Analgesic Consumption
Description
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
Title
Opioid-Related Symptom Distress Scale (ORSDS) Score
Description
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
Title
Cognitive Recovery
Description
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
Title
Incidence of Urinary Catheterization
Time Frame
Duration of stay in recovery room after surgery (average 2 hours)
Title
Anesthesia-related Postoperative Complications
Description
Measuring any anesthesia-related post-op complications that occured (yes or no)
Time Frame
Surgery start to postoperative day 1
Title
Assessment of Patient Blinding to Group Assignment
Description
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
Title
Patient Satisfaction
Description
Yes/no if patients would request the same anesthetic that they received
Time Frame
POD1
Title
Cognitive Recovery at 2 Hours Post-operative
Description
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
Title
Cognitive Recovery on POD1
Description
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
Title
Nausea Intensity
Description
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
Title
Back Pain on POD1
Description
Back pain (yes/no) on POD1
Time Frame
Postoperative day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacques YaDeau, MD
Organizational Affiliation
Hospital for Special Surgery, New York
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital for Special Surgery, New York
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29847387
Citation
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.
Results Reference
derived

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

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