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

NCT02996591 | Completed Phase 4 Results

• 1 other identifier: 2016-0499
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (21)

• Numerical Rating Scale (NRS) Pain Scores at 1 Hour Postop

  1 hour after PACU admission

• Numerical Rating Scale Pain Scores at 2 Hours Postop

  2 hours after PACU admission

• Numerical Rating Scale Pain Scores on Postoperative Day (POD) 1

  24 hours after surgery

• Postoperative Discomfort and Needs (Post-op Pain, Sore Throat, Back Pain, Nausea, Cold, Hunger, Thirst)

  1 hour after surgery

• Postoperative Discomfort and Needs (Post-op Pain, Sore Throat, Back Pain, Nausea, Cold, Hunger, Thirst)

  2 hours after surgery

Study Arms (2)

Spinal anesthesia with popliteal and adductor canal blocks.

ACTIVE COMPARATOR

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

General anesthesia with popliteal and adductor canal blocks.

ACTIVE COMPARATOR

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

Interventions

25 mL of 0.25% bupivacaine plus 2 mg preservative-free (PF) dexamethasone / 30 ml for popliteal nerve block PROCEDURE

General anesthesia with popliteal and adductor canal blocks.; Spinal anesthesia with popliteal and adductor canal blocks.

10 mL of 0.25% bupivacaine plus 2 mg preservative-free (PF) dexamethasone / 30 ml for adductor canal nerve block PROCEDURE

General anesthesia with popliteal and adductor canal blocks.; Spinal anesthesia with popliteal and adductor canal blocks.

Midazolam, 2-5 mg IV + Glycopyrrolate, 0.1 mg IV + Ketamine, 10-20 mg + propofol as needed DRUG

General anesthesia with popliteal and adductor canal blocks.; Spinal anesthesia with popliteal and adductor canal blocks.

45-60 mg of 1.5% mepivacaine for spinal anesthesia PROCEDURE

Spinal anesthesia with popliteal and adductor canal blocks.

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

General anesthesia with popliteal and adductor canal blocks.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

Hospital for Special Surgery, New York

New York, New York, 10021, United States

Location

Related Publications (1)

• 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.

  PMID: 29847387 DERIVED

MeSH Terms

Conditions

Pain; Postoperative Nausea and Vomiting

Interventions

Bupivacaine; Dexamethasone; Midazolam; Glycopyrrolate; Ketamine; Propofol; Health Services Needs and Demand; Mepivacaine; Anesthesia, Spinal; Sevoflurane; Anesthesia, General

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Nausea; Signs and Symptoms, Digestive; Vomiting

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quaternary Ammonium Compounds; Onium Compounds; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Health Services Research; Health Planning; Health Care Economics and Organizations; Delivery of Health Care; Health Care Quality, Access, and Evaluation; Piperidines; Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Results Point of Contact

• Title: George Birch
• Organization: Hospital for Special Surgery

birchg@hss.edu

2127747377

Study Officials

• Jacques YaDeau, MD

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2016
• First Posted: December 19, 2016
• Study Start: January 1, 2017
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: November 12, 2019
• Results First Posted: November 12, 2019

Record last verified: 2019-11

Locations

US (1)