Comparison of Pain Relief After Non Stimulating Interscalene Catheter Placement vs Stimulating Catheter Placement in Total Shoulder Arthroplasty.
Condition: Pain; Shoulder; Arthroplasty
Study type: Observational

Summary: 
      1. Interscalene continuous catheter is a very effective way of controlling pain in total
           shoulder arthroplasty. To ensure proper placement, nerve stimulating catheter is quite
           often used.

        2. Ultrasound can help proper placement of catheter without relying on nerve stimulation.

        3. The plan of the study is to compare two techniques head to head to see if they are
           equally effective or one is better than others.
    

Detailed description: 
      After consent patients will be randomized to one of the two groups: Control Group or the
      Experimental Group. Patients will be blinded to the group assignment. As both catheters are
      placed using almost the same technique, the subjects will be unable to tell type of catheter
      they will be getting..

      Every procedure will be done after starting intravenous access and placing standard
      anesthesia monitors (EKG, Blood Pressure Cuff and Pulse-Ox) on the patients. For comfort care
      sedation will be titrated using accepted American Society of Anesthesiology and American
      society of Regional Anesthesia Guidelines.

      In the Control Group the patient will have interscalene catheter placed using nerve
      stimulation technique. Initially ultrasound guidance will be used to visualize brachial
      plexus at the cricoid level with the intent to visualize upper trunks or roots. Then
      following established guidelines a nerve stimulating catheter will be placed. This will be
      done using an ARROW NERVE KIT. The kit is FAD approved for this purpose.. Following accepted
      aseptic guidelines the nerves will be visualized at the base of the neck using ultrasound
      machine. Once proper nerve roots or trunks visualized, kit provided 17gauge insulated Touhy
      needle will be used to access the brachial plexus. Once twitches elicited in Deltoid, biceps
      or triceps muscles at 0.5 mamp, catheter will be threaded via the needle while maintaining
      twitch at 0.5 mamp or less. Once catheter is threaded 3 cm beyond the tip, Touhy needle will
      be removed. Catheter will be tested for proper placement using lidocaine and epinephrine as
      is recommended by Regional Anesthesia Society guidelines. Thereafter 3 mg/kg of 0.5 %
      bupivacaine will be injected in small blouses via the catheter.

      In the Experimental Group, after placement of monitors, the nerves will be visualized using
      ultrasound machine. Once nerve visualized at the cricoids level, proper tip of Touhy needle
      will be guided using hydro-dissection technique. Once in good place, catheter will be
      threaded 3 cm into the space. They subjects will be dosed using 0.5% bupivacaine 3 mg/kg for
      the surgery via the catheter. Adequacy of catheter placement will be judged by examining the
      spread of local anesthetics around the plexus.

      The extent of block before the surgery will be evaluated at 30 minutes post injection.
      Surgery will be done with sedation. Conversion of anesthetic technique to general anesthesia
      will be considered failure of the technique to provide adequate surgical anesthesia.

      At the end of the case the patient will be taken to recovery and will be evaluated for pain.
      If patient is having pain of 3 or more then they will be treated as follows.

      In each catheter group patient will be dosed with 10 ml 1% lidocaine. If it fails to provide
      any relief then the catheter will be pulled back and another 10 ml1% lidocaine will be given.
      If still not effective then it will be replaced. Refusal of patient to replace the catheter
      will result in pt dropping out of the study.

      Working catheter will be left in place for at least 48 hrs. Patients will be allowed to take
      oral pain medicines as prescribed by their surgeons. The patient will be sent home with pain
      pump to continuously give them 0.125% bupivacaine at 5 ml per hr with an option to get extra
      dose of 5 ml every one hr if needed. The pain control will be monitored while in-house and by
      phone daily till catheter comes out.
    

Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        all subjects having total shoulder arthroplasty.
      
Keywords: nerve block; continuous catheter; shoulder surgery; pain control after total shoulder arthroplasty