Liposome Bupivacaine in Interscalene Block for Rotator Cuff Repair
Status: | Recruiting |
---|---|
Conditions: | Chronic Pain |
Therapuetic Areas: | Musculoskeletal |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 7/21/2018 |
Start Date: | July 16, 2018 |
End Date: | June 2019 |
Contact: | Tenzin Desa, MD |
Email: | desax002@umn.edu |
Phone: | 612-624-9990 |
Prospective Randomized Controlled Pilot Study Comparing Liposomal Bupivacaine to Bupivacaine Interscalene Blocks for Arthroscopic Rotator Cuff Repair Surgery
The purpose of this study is to compare pain control after arthroscopic rotator cuff repair
surgery using either liposomal bupivacaine or bupivacaine when injected in an interscalene
block. Both medications, liposomal bupivacaine and bupivacaine, are standard of care in these
types of surgeries.
surgery using either liposomal bupivacaine or bupivacaine when injected in an interscalene
block. Both medications, liposomal bupivacaine and bupivacaine, are standard of care in these
types of surgeries.
All patients will receive preoperative oral multimodal medications consisting of
acetaminophen 975 mg, gabapentin 300 mg, and Celebrex 400 mg.
After completion of the preoperative process the patient will be placed in the supine
position with the head of the bed elevated 30 degrees with standard ASA monitors applied.
Sedation will be provided with midazolam 0-2 mg and propofol 50 mg. The interscalene groove
will be identified with the ultrasound. Using sterile technique, a 21g Nerve block needle
will then be inserted and advanced under ultrasound guidance until it is in the interscalene
groove. Once in the interscalene, 20 mL of local anesthetic will be injected, with 10 mL
deposited at the top of the brachial plexus and 10 mL at the bottom. In the study group, 5 mL
of each 0.5% bupivacaine and LB will be injected at each location. The control group with
have 20 mL of 0.5% bupivacaine divided between the injection sites. The patient will be
monitored in the preoperative area until he/she is brought into the operating room for their
procedure. A working block prior to surgery will be confirmed via sensory testing of the
shoulder.
All patients will undergo a standard induction with propofol 1.5-3.0 mg/kg, ondansetron 4 mg,
dexamethasone 10 mg and ketamine 0.25 mg/kg. A MAC or general with LMA or ETT will be placed
and an opioid sparing technique will occur. Standardized maintenance will be a propofol
infusion without neuromuscular blockers. 25-50 mcg of IV Fentanyl will be utilized for
increases in heart rate greater than 20% or increases in systolic blood pressure above
baseline.
Once in the operating room the surgeon will use 10 mL of 0.25% bupivacaine for skin,
subcutaneous, and intraarticular injection.
When the operation is complete, the patient will be woken up and brought to the PACU. There
the patient will receive IV fentanyl for a pain score of greater than 7. If more than 100 mcg
of fentanyl is given and pain still remains above a 7 then IV hydromorphone will be used. A
dose of 5-10 mg of oral oxycodone (or 2-4 mg of oral hydromorphone) will be given as soon as
the patient is able to tolerate oral medication per standard protocol: If their pain score is
4-6 (on the Visual Analog Scale) then 5mg oral oxycodone (2 mg hydromorphone) can be
administered, if their pain is between 7 to 10 then 10 mg of oxycodone (or 4 mg of
hydromorphone) can be administered. Once the patient meets discharge criteria, they will be
discharged home where each day they will fill out a pain diary. Additionally, a member of the
research team will call the patient for signs of complications and ask the patient their
current pain score, total opioid pills taken and non-opioid pain medication taken at 24, 48,
and 72 hours postoperatively. Additionally, they will perform a Quality of Recovery Score
survey at 72 hours, and 14 days postoperatively. An Ultrasound of the diaphragm will be
completed by a blinded anesthesiologist in the PACU to assess diaphragm function.
All patients will be discharged with acetaminophen 975 mg q6 hours & ibuprofen 600 mg q6
hours, taken in intervals such that the patient is taking one of these medications every 3
hours. And then hydromorphone 2mg pills #60 dosing 1-2 pills q4 hours prn severe pain or
oxycodone 5 mg pills #60 dosing 1-2 pills q 4 hours prn severe pain.
acetaminophen 975 mg, gabapentin 300 mg, and Celebrex 400 mg.
After completion of the preoperative process the patient will be placed in the supine
position with the head of the bed elevated 30 degrees with standard ASA monitors applied.
Sedation will be provided with midazolam 0-2 mg and propofol 50 mg. The interscalene groove
will be identified with the ultrasound. Using sterile technique, a 21g Nerve block needle
will then be inserted and advanced under ultrasound guidance until it is in the interscalene
groove. Once in the interscalene, 20 mL of local anesthetic will be injected, with 10 mL
deposited at the top of the brachial plexus and 10 mL at the bottom. In the study group, 5 mL
of each 0.5% bupivacaine and LB will be injected at each location. The control group with
have 20 mL of 0.5% bupivacaine divided between the injection sites. The patient will be
monitored in the preoperative area until he/she is brought into the operating room for their
procedure. A working block prior to surgery will be confirmed via sensory testing of the
shoulder.
All patients will undergo a standard induction with propofol 1.5-3.0 mg/kg, ondansetron 4 mg,
dexamethasone 10 mg and ketamine 0.25 mg/kg. A MAC or general with LMA or ETT will be placed
and an opioid sparing technique will occur. Standardized maintenance will be a propofol
infusion without neuromuscular blockers. 25-50 mcg of IV Fentanyl will be utilized for
increases in heart rate greater than 20% or increases in systolic blood pressure above
baseline.
Once in the operating room the surgeon will use 10 mL of 0.25% bupivacaine for skin,
subcutaneous, and intraarticular injection.
When the operation is complete, the patient will be woken up and brought to the PACU. There
the patient will receive IV fentanyl for a pain score of greater than 7. If more than 100 mcg
of fentanyl is given and pain still remains above a 7 then IV hydromorphone will be used. A
dose of 5-10 mg of oral oxycodone (or 2-4 mg of oral hydromorphone) will be given as soon as
the patient is able to tolerate oral medication per standard protocol: If their pain score is
4-6 (on the Visual Analog Scale) then 5mg oral oxycodone (2 mg hydromorphone) can be
administered, if their pain is between 7 to 10 then 10 mg of oxycodone (or 4 mg of
hydromorphone) can be administered. Once the patient meets discharge criteria, they will be
discharged home where each day they will fill out a pain diary. Additionally, a member of the
research team will call the patient for signs of complications and ask the patient their
current pain score, total opioid pills taken and non-opioid pain medication taken at 24, 48,
and 72 hours postoperatively. Additionally, they will perform a Quality of Recovery Score
survey at 72 hours, and 14 days postoperatively. An Ultrasound of the diaphragm will be
completed by a blinded anesthesiologist in the PACU to assess diaphragm function.
All patients will be discharged with acetaminophen 975 mg q6 hours & ibuprofen 600 mg q6
hours, taken in intervals such that the patient is taking one of these medications every 3
hours. And then hydromorphone 2mg pills #60 dosing 1-2 pills q4 hours prn severe pain or
oxycodone 5 mg pills #60 dosing 1-2 pills q 4 hours prn severe pain.
Inclusion Criteria:
- Adult patients aged greater than 18 years of age that are undergoing arthroscopic
rotator cuff surgery
Exclusion Criteria:
- Patients with allergy to local anesthetics
- Patients with daily use of opioids for more than 3 weeks prior to surgery
- Patients who refuse
- Patients with coagulopathy
- Patients who are non-english speaking
- Patients who do not have access to a telephone
We found this trial at
1
site
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
Click here to add this to my saved trials