Single Shot Versus OnQ Pump in Extremity Fractures
Condition: Pain; Fracture
MeSH terms: Fractures, Bone
Study type: Interventional
Phase: Phase 4

Summary: 
      Peripheral nerve blocks have been well studied in the literature with generally good results
      for controlling post operative pain following orthopaedic surgery. Regional anesthesia has
      many benefits. It provides excellent intraoperative anesthesia and muscle relaxation as well
      as analgesia that continues into the post-operative period. These regional blocks are also
      effective in controlling pain in the immediate post-operative period. However, as the block
      wears off, patients begin experiencing increased pain. Compared to patients treated without
      regional blocks, these patients will often experience a "rebound pain"--pain occurring 12-24
      hours after surgery that is subjectively worse than that in patients treated without regional
      blocks. Therefore, the investigators propose to use a continuous infusion of anesthetic in
      order to provide sustained pain control post-operatively. Preoperatively, patients will be
      randomized into a single shot peripheral nerve block versus a continuous infusion of
      peripheral nerve block. Post-operatively, pain will be assessed using the Visual Analogue
      Scale (1-100) prior to being discharged from PACU. Time to discharge and amount of pain
      medication taken will be recorded. Patients will be contacted at certain time intervals
      postoperatively to assess their pain scale and pain medication intake. Patients will be seen
      for routine post-operative follow-up visits where they will be assessed for satisfaction,
      pain, residual neurological symptoms, and signs of infection.
    

Detailed description: 
      Purpose The purpose of this randomized prospective study will be to compare post-operative
      pain control after extremity fracture fixation surgery between patients who receive single
      shot versus continuous peripheral nerve blocks.

      Scientific or Scholarly Rationale Peripheral nerve blocks have been well studied in the
      literature with generally good results for controlling post operative pain following
      orthopaedic surgery 1-4. Regional anesthesia has many benefits. It provides excellent
      intraoperative anesthesia and muscle relaxation as well as analgesia that continues into the
      post-operative period. Airway manipulations are avoided, post-operative nausea and vomiting
      are diminished, post-anesthesia care unit stay are shortened, and fewer nursing interventions
      in the post-anesthesia care unit are required5-6.

      Patients who have operative fixation of extremity fractures (ankle, wrist, forearm) are
      typically ambulatory patients. However, many become hospitalized overnight secondary to
      inadequate pain control, increasing hospital costs. Goldstein et al. showed that patients who
      underwent popliteal blocks after ankle fracture fixation demonstrated significantly better
      pain control immediately postoperatively7. The need for overnight hospitalization secondary
      to pain is decreased, as are nonsurgical operating room times.

      Despite the success of regional anesthesia, a phenomenon known as "rebound pain" has been
      shown to occur as the original block wears off7-9. Patients with blocks will experience
      significantly increased pain compared to those without blocks approximately 12-24 hours after
      surgery. This can be controlled with early narcotic administration but can be a source of
      significant discomfort to a patient if not recognized and treated in time. A few studies have
      shown that continuous infusions of various numbing agents are efficacious in prolonged pain
      control, even in the ambulatory setting10-12. Nevertheless, no studies have thus performed a
      randomized prospective control trial studying the efficacy of continuous infusion therapy on
      pain control following extremity fracture surgery.

      Aims

        1. To determine the effectiveness of continuously infused regional anesthetic for pain
           control in extremity fracture surgery

        2. To determine the effect of rebound pain on patient satisfaction of surgery Description
           of study and study procedure Consent All patients being treated with open reduction
           internal fixation for foot, ankle, tibia, elbow, forearm and wrist fractures at New York
           University Medical Center, NYU-Hospital for Joint Diseases will be asked to participate
           in this study. At the patients preoperative office visit, they will be asked to
           participate in the study and provided a copy of the consent form at that time which they
           can take home with them. All questions will be answered and they will be asked verbally
           if they will consent to being a part of the study. Patients will then have the
           opportunity to either sign the written consent forms or wait till the surgical date to
           think about the study and any additional questions they may have. At the time of
           surgery, patients will be consented for surgery. If the patient did not give written
           consent at the preoperative visit, they will be asked if they have any questions about
           the study. All questions will again be answered. They will then be asked verbally if
           they are willing to participate in the study, if they respond yes, then written consent
           will be obtained at that time.

      Randomization Patients will then be randomized (using an online randomizer, similar to a flip
      of a coin) to one of two anesthetic protocols: regional block with single dose of anesthetic
      versus regional block with continuous infusion using an OnQ pump. If for some reason, the
      anesthesiologist feels that a patient would benefit from one type of anesthesia over another,
      the patient will be removed from the study and given that type of anesthesia.

      Intervention Patients will be randomized to one of two anesthetic protocols: general
      anesthesia/sedation with a single shot, peripheral nerve block versus general
      anesthesia/sedation with a continuous, peripheral nerve block.

      All anesthesia will be provided by an attending anesthesiologist with or without an
      anesthesiology resident/CRNA. Patients will have standard ASA monitors placed (pulse
      oximeter, blood pressure, EKG) and an intravenous line started. Sedation will be given using
      a combination of midazolam (1-4 mg) and fentanyl (25-100 mcg). Patients in both groups will
      receive an ultrasound-guided peripheral nerve block. The block will be either an
      infraclavicular brachial plexus block or a popliteal nerve block, depending on the location
      of the fracture. The appropriate region will be prepped with a chlorohexidine solution on the
      appropriate surgical side and the appropriate site will be visualized under ultrasound. For
      the group receiving a single shot block, a 22 gauge, 3.5 inch needle will be used and 20cc of
      2% lidocaine with 1:200,000 epinephrine + 20 cc of 0.5% bupivacaine with 1:300,000
      epinephrine will be injected around the nerve after confirming negative aspiration every 5
      cc. For those receiving a continuous infusion, a 17 gauge Tuohy needle will be used and 20cc
      of 2% lidocaine with epinephrine + 20 cc of 0.5% bupivacaine with 1:300,000 epinephrine will
      be injected around the nerve after confirming negative aspiration every 5cc. Once the
      injection is complete, an indwelling catheter will be placed with its tip location confirmed
      and then secured at the skin.

      After placement of the regional block, general anesthesia/sedation will be administered and
      maintained at the discretion of the anesthesiologist. Induction of anesthesia will involve IV
      propofol (2mg/kg) and fentanyl (1-2mcg/kg). Neuromuscular blockade will be used at the
      discretion of the anesthesiologist and will be reversed appropriately. Anesthetic maintenance
      will involve inhalational agents, IV agents, air, and oxygen. Fentanyl will be the only
      intraoperative analgesic used and will be dosed as determined by the anesthesiologist.

      After completion of the surgery, patients will be taken to the PACU where those with
      continuous catheters will have an OnQ pump attached to it. The patient will begin receiving a
      continuous infusion of 0.2% ropivacaine through the catheter at a rate of 8 cc/hr. The
      patient will be discharged home with the catheter for 48 hours. The study participant will
      self-discontinue the catheter in 2 days. This involves removing the tegaderm dressing and
      gently pulling the catheter out from under the skin. A bandage may then be applied. Germaine
      Cuff, the investigators anesthesiology RN, will be available via phone to answer any
      questions study participants may have regarding discontinuation of the catheter. Breakthrough
      pain while in the PACU will be treated with IV fentanyl and PO Percocet as needed.

      Postoperatively, all patients will be discharged home with a prescription for Percocet 5/325
      with instructions to take 1-2 tabs every 4-6hrs as needed for pain.

      Data collection Location and type of surgical procedure, duration of procedure, and duration
      of intravenous sedation will also be recorded. Total time in the operating room will also be
      noted. Time admitted to PACU, time clinically ready for discharge, time actually discharge,
      PACU medications for nausea/vomiting and PACU meds for pain will all be recorded prior to
      discharge.

      Post-operative pain will be assessed using the Visual Analogue Scale (0-100) prior to being
      discharged from PACU. Time to discharge and amount of pain medication taken in the PACU will
      be recorded.

      Patients will be contacted 8 hours, 12 hours, 24 hours, 48 hours and 72hrs after surgery by
      the operative surgeon or research coordinator to assess their pain scale and pain medication
      intake. Patients will be seen for routine post-operative follow-up visits at two, six,
      twelve, twenty-four, and fifty-two weeks. At these times, patients will be assessed for pain,
      residual neurological symptoms, and signs of infection. Patients will also be asked if they
      were satisfied with their postoperative pain control. Total duration of study will be
      fifty-two weeks. Data collection documents will be distributed to the patients at time of
      surgery to assist in patient understanding.
    

Intervention name(s): Ankle SSB; Ankle OnQ; DR SSB; DR OnQ
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): general anesthesia/sedation with a single shot; Primary predictor variable: single shot block, a 22 gauge, 3.5 inch needle will be used and 20cc of 2% lidocaine with 1:200,000 epinephrine + 20cc of 0.5% bupivacaine with 1:300,000 epinephrine will be injected around the nerve after confirming negative aspiration every 5 cc.; versus regional block with continuous infusion using an OnQ pump. 17 gauge Tuohy needle will be used and 20cc of 2% lidocaine with epinephrine +20cc of 0.5% bupivacaine with1:300,000epinephrine will be injected around the nerve after confirming negative aspiration every 5cc.; general anesthesia/sedationwith a single shot; general anesthesia/sedation with a single shot; Primary predictor variable: single shot block, a 22 gauge, 3.5 inch needle will be used and 20cc of 2% lidocaine with 1:200,000 epinephrine + 20cc of 0.5% bupivacaine with 1:300,000 epinephrine will be injected around the nerve after confirming negative aspiration every 5 cc.; versus regional block with continuous infusion using an OnQ pump. 17 gauge Tuohy needle will be used and 20cc of 2% lidocaine with epinephrine +20cc of 0.5% bupivacaine with1:300,000epinephrine will be injected around the nerve after confirming negative aspiration every 5cc.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment