Single Shot vs Continuous Interscalene Block for Rotator Cuff Repair

Pain Clinical Trial

Official title:

Comparison of Pain Relief After Single Shot Interscalene Block With Continuous Interscalene Block for Arthroscopic Rotator Cuff Shoulder Surgery: A Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01122745
• Other study ID #: 10-243-B
• Status: Completed
• Phase: N/A
• First received: May 11, 2010
• Last updated: May 29, 2014
• Start date: August 2010
• Est. completion date: October 2013

Study information

• Verified date: May 2014
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Pain
• Rotator Cuff
• Surgery

Locations

Country	Name	City	State
United States	University of Chicago Hospitals	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain relief	Patients having rotator cuff repair surgery will be randomized to either single shot or continuous catheter group. Pain score will be followed for 2 days to see which group gets better pain relief.	2-3 days	No