- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02996591
Spinal Versus General Anesthesia With Popliteal and Adductor Canal Blocks for Ambulatory Foot and Ankle Surgery. (LMA vs Spinal)
Spinal Versus General Anesthesia With Popliteal and Adductor Canal Blocks for Ambulatory Foot and Ankle Surgery: A Double-Blinded Randomized Controlled Trial.
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 Overview
Status
Intervention / Treatment
- 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
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10021
- Hospital for Special Surgery, New York
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time Until Patient is Ready for Discharge From Post-Anesthesia Care Unit (PACU) to Home.
Time Frame: Duration of stay in recovery room after surgery
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Modified Aldrete Scoring System and Marshall and Chung Postanesthesia Discharge Scoring System, measured in time until discharge criteria is met (in minutes)
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Duration of stay in recovery room after surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Numerical Rating Scale (NRS) Pain Scores at 1 Hour Postop
Time Frame: 1 hour after PACU admission
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NRS Pain scores at 1 hour after surgery.
Rated on a scale of 0 (no pain) to 10 (worst pain imaginable).
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1 hour after PACU admission
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Numerical Rating Scale Pain Scores at 2 Hours Postop
Time Frame: 2 hours after PACU admission
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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).
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2 hours after PACU admission
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Numerical Rating Scale Pain Scores on Postoperative Day (POD) 1
Time Frame: 24 hours after surgery
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Numerical Rating Scale Pain from 0-10.
0 being no pain at all. 10 being the worst pain imaginable.
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24 hours after surgery
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Postoperative Discomfort and Needs (Post-op Pain, Sore Throat, Back Pain, Nausea, Cold, Hunger, Thirst)
Time Frame: 1 hour after surgery
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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.
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1 hour after surgery
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Postoperative Discomfort and Needs (Post-op Pain, Sore Throat, Back Pain, Nausea, Cold, Hunger, Thirst)
Time Frame: 2 hours after surgery
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Rating the Nausea/Vomiting of patients post-operatively.
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2 hours after surgery
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Postoperative Discomfort and Needs (Post-op Pain, Sore Throat, Back Pain, Nausea, Cold, Hunger, Thirst)
Time Frame: Postoperative day 1
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Leiden Perioperative Care Patient Satisfaction questionnaire (LPPSq).
From 1-5. 1 being not at all. 5 being extremely.
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Postoperative day 1
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Incidence of Post-dural Puncture Headache
Time Frame: Postoperative day 1 and if present, monitored until resolution
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Postoperative day 1 and if present, monitored until resolution
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Incidence of Transient Neurologic Symptoms
Time Frame: Postoperative day 1 and if present, monitored until resolution
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Postoperative day 1 and if present, monitored until resolution
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Opioid Consumption
Time Frame: Duration of stay in recovery room after surgery (average 2 hours)
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Opioid consumption (mg OME) during inpatient stay
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Duration of stay in recovery room after surgery (average 2 hours)
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Opioid Consumption Through First Postoperative Day. Measured in mg OME
Time Frame: Postoperative day 1
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Postoperative day 1
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Non-opioid Analgesic Consumption
Time Frame: Hospital discharge to postoperative day 1
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The number of patients who took non-opioid analgesic medication for post-operative pain between hospital discharge and postoperative day 1.
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Hospital discharge to postoperative day 1
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Opioid-Related Symptom Distress Scale (ORSDS) Score
Time Frame: 2 hours after surgery
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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.
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2 hours after surgery
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Cognitive Recovery
Time Frame: 1 hour after surgery
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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)
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1 hour after surgery
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Incidence of Urinary Catheterization
Time Frame: Duration of stay in recovery room after surgery (average 2 hours)
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Duration of stay in recovery room after surgery (average 2 hours)
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Anesthesia-related Postoperative Complications
Time Frame: Surgery start to postoperative day 1
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Measuring any anesthesia-related post-op complications that occured (yes or no)
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Surgery start to postoperative day 1
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Assessment of Patient Blinding to Group Assignment
Time Frame: Postoperative day 1
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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.
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Postoperative day 1
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Patient Satisfaction
Time Frame: POD1
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Yes/no if patients would request the same anesthetic that they received
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POD1
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Cognitive Recovery at 2 Hours Post-operative
Time Frame: 2 hours after PACU admission
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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)
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2 hours after PACU admission
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Cognitive Recovery on POD1
Time Frame: Postoperative day 1
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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)
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Postoperative day 1
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Nausea Intensity
Time Frame: 2 hours after PACU admission
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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.
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2 hours after PACU admission
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Back Pain on POD1
Time Frame: Postoperative day 1
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Back pain (yes/no) on POD1
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Postoperative day 1
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Collaborators and Investigators
Investigators
- Principal Investigator: Jacques YaDeau, MD, Hospital for Special Surgery, New York
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Signs and Symptoms, Digestive
- Nausea
- Vomiting
- Postoperative Nausea and Vomiting
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Muscarinic Antagonists
- Cholinergic Antagonists
- Cholinergic Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anesthetics, Dissociative
- Anesthetics, Intravenous
- Anesthetics, General
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Anti-Inflammatory Agents
- Platelet Aggregation Inhibitors
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Protease Inhibitors
- Tranquilizing Agents
- Psychotropic Drugs
- Hypnotics and Sedatives
- Adjuvants, Anesthesia
- Anti-Anxiety Agents
- GABA Modulators
- GABA Agents
- Anesthetics, Local
- Anesthetics, Inhalation
- Ketamine
- Dexamethasone
- Dexamethasone acetate
- BB 1101
- Anesthetics
- Midazolam
- Propofol
- Sevoflurane
- Bupivacaine
- Glycopyrrolate
- Mepivacaine
Other Study ID Numbers
- 2016-0499
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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