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

Pain Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02996591
• Other study ID #: 2016-0499
• Status: Completed
• Phase: Phase 4
• Start date: January 2017
• Est. completion date: May 2017

Study information

• Verified date: November 2019
• Source: Hospital for Special Surgery, New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• General Anesthesia
• Nausea
• Nerve Block
• Pain
• Postoperative Nausea and Vomiting
• Spinal Anesthesia
• Vomiting

Intervention

Procedure:
• 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

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

• LMA insertion + titrated propofol infusion + sevoflurane + ketamine 10 mg/hr for general anesthesia

Locations

Country	Name	City	State
United States	Hospital for Special Surgery, New York	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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)	Duration of stay in recovery room after surgery
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).	1 hour after PACU admission
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).	2 hours after PACU admission
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.	24 hours after surgery
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.	1 hour after surgery
Secondary	Postoperative Discomfort and Needs (Post-op Pain, Sore Throat, Back Pain, Nausea, Cold, Hunger, Thirst)	Rating the Nausea/Vomiting of patients post-operatively.	2 hours after surgery
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.	Postoperative day 1
Secondary	Incidence of Post-dural Puncture Headache		Postoperative day 1 and if present, monitored until resolution
Secondary	Incidence of Transient Neurologic Symptoms		Postoperative day 1 and if present, monitored until resolution
Secondary	Opioid Consumption	Opioid consumption (mg OME) during inpatient stay	Duration of stay in recovery room after surgery (average 2 hours)
Secondary	Opioid Consumption Through First Postoperative Day. Measured in mg OME		Postoperative day 1
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.	Hospital discharge to postoperative day 1
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.	2 hours after surgery
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)	1 hour after surgery
Secondary	Incidence of Urinary Catheterization		Duration of stay in recovery room after surgery (average 2 hours)
Secondary	Anesthesia-related Postoperative Complications	Measuring any anesthesia-related post-op complications that occured (yes or no)	Surgery start to postoperative day 1
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.	Postoperative day 1
Secondary	Patient Satisfaction	Yes/no if patients would request the same anesthetic that they received	POD1
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)	2 hours after PACU admission
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)	Postoperative day 1
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.	2 hours after PACU admission
Secondary	Back Pain on POD1	Back pain (yes/no) on POD1	Postoperative day 1