Clinical trial NCT01122745: Single Shot vs Continuous Interscalene Block for Rotator Cuff Repair
Official title: Comparison of Pain Relief After Single Shot Interscalene Block With Continuous Interscalene Block for Arthroscopic Rotator Cuff Shoulder Surgery: A Randomized Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Rotator Cuff
Surgery
Keywords: continuous block
single shot
interscalene
rotator cuff surgery
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2010-05-13
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All pateint undergoing arthroscopic rotator cuff surgrey and agreed to have regional block for pain control

Brief summary: 1. Rotator cuff have painful post surgery recovery.
2. Single shot interscalene with oral analgesics may or may not be enough
3. Continuous nerve block may be too much for the surgery
4. The idea is to compare two techniques to see if the two techniques can improve patient pain control and satisfaction.

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.

In the Control Group the patient will be given single shot interscalene block using ultrasound technique following established guidelines. The procedure will be done after starting intravenous access and placing standard anesthesia monitors (EKG, Blood Pressure Cuff and Pulse-Ox) on the patient. 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 3 mg/kg of 0.5 % bupivacaine will be injected in small blouses.

In the Experimental Group, after placement of monitors, the nerves will be visualized using ultrasound machine. There after a catheter will be placed. They subjects will be dosed using 0.5% bupivacaine 3 mg/kg for the surgery via the catheter.

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 single shot group will be offered to be blocked again or treated with oral narcotics.

In the 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 patient 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 q hr if needed. The pain control will be monitored by phone daily till catheter comes out.

Eligibility criteria: Inclusion Criteria:

* adult
* rotator cuff surgery
* agreeing to regional block for pain control

Exclusion Criteria:

* pregnancy
* neuropathy
* any allergies to local anesthetics
* any contraindication to nerve blocks

Primary outcomes:
measure: pain relief
timeFrame: 2-3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago Hospitals
state: Illinois
Study officials:
References: