Comparison of Pain Relief After Non Stimulating Interscalene Catheter Placement vs Stimulating Catheter Placement in Total Shoulder Arthroplasty.
| Status: | Completed |
|---|---|
| Conditions: | Chronic Pain, Orthopedic |
| Therapuetic Areas: | Musculoskeletal, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - 90 |
| Updated: | 4/2/2016 |
| Start Date: | August 2010 |
| End Date: | September 2013 |
| Contact: | TARIQ MALIK, MD |
| Email: | tmalik@dacc.uchicago.edu |
| Phone: | 7738343643 |
Comparison of Pain Relief After US Guided Non Stimulating Interscalene Catheter Placement vs Stimulating Catheter Placement in Total Shoulder Arthroplasty;a Randomized Study
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.
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.
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.
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.
Inclusion Criteria:
- 18 yr or older
- patient agreed to continuous regional block
Exclusion Criteria:
- minor
- patient refusal
- any neuropathy
- allergies to local anesthetic,
- inability to obtain informed consent for any reason, Opioid user, chronic pain
patients or unanticipated procedure other than total shoulder arthroplasty
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