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

This study is currently recruiting participants.
Verified July 2017 by Hospital for Special Surgery, New York
Sponsor:
ClinicalTrials.gov Identifier:
NCT02996591
First Posted: December 19, 2016
Last Update Posted: July 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Hospital for Special Surgery, New York
  Purpose

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.


Condition Intervention Phase
Nerve Block General Anesthesia Spinal Anesthesia Pain Postoperative Nausea and Vomiting 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 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Spinal Versus General Anesthesia With Popliteal and Adductor Canal Blocks for Ambulatory Foot and Ankle Surgery: A Double-Blinded Randomized Controlled Trial.

Resource links provided by NLM:


Further study details as provided by Hospital for Special Surgery, New York:

Primary Outcome Measures:
  • Readiness for discharge to home [ Time Frame: Duration of stay in recovery room after surgery (average 2 hours) ]
    Modified Aldrete Scoring System and Marshall and Chung Postanesthesia Discharge Scoring System


Secondary Outcome Measures:
  • Numerical rating scale pain scores [ Time Frame: 1 hour after surgery, 2 hours after surgery ]
  • Patient satisfaction with perioperative care [ Time Frame: Postoperative day 1 ]
    Leiden Perioperative Care Patient Satisfaction questionnaire (LPPSq)

  • Postoperative discomfort and needs (post-op pain, sore throat, back pain, nausea, cold, hunger, thirst) [ Time Frame: 1 hour after surgery, 2 hours after surgery, postoperative day 1 ]
    Leiden Perioperative Care Patient Satisfaction questionnaire (LPPSq)

  • Numerical rating scale nausea and vomiting [ Time Frame: 1 hour after surgery, 2 hours after surgery, 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 [ Time Frame: Duration of stay in recovery room after surgery (average 2 hours), postoperative day 1 ]
  • Non-opioid analgesic consumption [ Time Frame: Duration of stay in recovery room after surgery (average 2 hours), postoperative day 1 ]
  • Side effects [ Time Frame: 2 hours after surgery ]
    Opioid-related symptom distress scale

  • Cognitive recovery [ Time Frame: 1 hour after surgery, 2 hours after surgery, postoperative day 1 ]
    Postoperative Quality Recovery Scale Cognitive Domain

  • Incidence of urinary catheterization [ Time Frame: Duration of stay in recovery room after surgery (average 2 hours) ]
  • Anesthesia-related postoperative complications [ Time Frame: Duration of stay in recovery room after surgery (average 2 hours), postoperative day 1 ]
  • Assessment of patient blinding to group assignment [ Time Frame: Postoperative day 1 ]
    Patients will be asked whether they believe they were in the general anesthesia or spinal anesthesia group.


Estimated Enrollment: 36
Study Start Date: January 2017
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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. 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 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
Active Comparator: 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.
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: LMA insertion + titrated propofol infusion + sevoflurane + ketamine 10 mg/hr for general anesthesia

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02996591


Contacts
Contact: George Birch 212-774-7377 ext 7377 birchg@hss.edu
Contact: Denesy Mancenido 212-774-2602 ext 2606 mancenidod@hss.edu

Locations
United States, New York
Hospital for Special Surgery, New York Recruiting
New York, New York, United States, 10021
Contact: George Birch    212-774-7377 ext 7377    birchg@hss.edu   
Contact: Denesy Mancenido    212-774-2602 ext 2602    mancenidod@hss.edu   
Principal Investigator: Jacques YaDeau, MD         
Sponsors and Collaborators
Hospital for Special Surgery, New York
Investigators
Principal Investigator: Jacques YaDeau, MD Hospital for Special Surgery, New York
  More Information

Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT02996591     History of Changes
Other Study ID Numbers: 2016-0499
First Submitted: December 2, 2016
First Posted: December 19, 2016
Last Update Posted: July 12, 2017
Last Verified: July 2017

Keywords provided by Hospital for Special Surgery, New York:
Nerve Block
General Anesthesia
Spinal Anesthesia
Pain
Postoperative Nausea and Vomiting

Additional relevant MeSH terms:
Nausea
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Anesthetics
Bupivacaine
Propofol
Ketamine
Midazolam
Sevoflurane
Mepivacaine
Dexamethasone acetate
Dexamethasone
BB 1101
Glycopyrrolate
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents