Interscalene Bupivacaine With Either Liposomal Bupivacaine or Continuous Peripheral Nerve Block for Shoulder Arthroscopy

The University of Texas System (UT)

Status

Completed

Conditions

Shoulder Pain

Treatments

Procedure: Single-injection bupivacaine HCl plus a subsequent bupivacaine CISB

Procedure: Single-injection bupivacaine HCl plus liposomal bupivacaine

Study type

Interventional

Funder types

Other

Identifiers

NCT03816982

STU 082018-017

Details and patient eligibility

About

This investigation will be a prospective, randomized trial. The study population will consist of adult patients scheduled to undergo major shoulder arthroscopy procedures with anesthesiology at the Ambulatory Services Center (Outpatient Surgery Center). Forty-six subjects will be enrolled in this study and will be randomized into one of two arms: 1) Single-injection bupivacaine HCl plus a subsequent bupivacaine CISB, 2) Single-injection bupivacaine HCl plus liposomal bupivacaine included in the same injection. These procedures will take place, using an ultrasound-guided method, approximately one hour prior to surgical procedure. Subjects will be followed for seven days to assess pain control by the Modified Brief Pain Inventory (MBPI) survey and outcome factors related to study and procedure using the American Shoulder and Elbow Surgeon Shoulder Score (ASES Shoulder Score).

Full description

Once potential candidates are identified, charts will be reviewed for initial data collection and to determine if the patient meets inclusion criteria and is free of exclusion criteria. Eligible individuals will be approached in clinic or will be called one to four days before their scheduled procedure and introduced to the study. They will have the opportunity to have the consent and HIPPA forms emailed to them to review before making the decision to participate in the study.

After consent, subjects will be randomized and enrolled into the study. Subjects will be randomized into one of two arms: 1) Single-injection bupivacaine HCl plus a subsequent bupivacaine CISB, 2) Single-injection bupivacaine HCl plus liposomal bupivacaine included in the same injection. Subjects in the first arm will undergo catheter placement with ultrasound guidance by a regional anesthesiologist on the study team. A 20 mL single bolus ISB with 0.25% bupivacaine will be administered followed by catheter infusion of 0.125% bupivacaine at a rate of 5 mL/hour postoperatively by the elastomeric pump. Subjects in the second arm will be given a single injection Liposomal Bupivacaine ISB in the preoperative area by a regional anesthesiologist on the study team. The injectate will include liposomal bupivacaine 10 mL (133 mg) mixed with bupivacaine HCl 0.5% 10 mL.

Both groups will receive a standardized analgesic regimen which will include the following: preoperative acetaminophen 15mg/kg up to 1gm PO and gabapentin 600 mg PO; intraoperative dexamethasone 8mg IV, fentanyl 100 - 250 mcg IV, ketamine 30 -50mg IV, and ketorolac 0.5mg/kg up to 30mg IV at conclusion of surgery; fentanyl IV in PACU as necessary; postoperative regimen will include acetaminophen 15mg/kg up to 1gm PO q8hrs, ibuprofen 400 mg Q8 hrs and tramadol 50 mg q4hrs prn. For continued breakthrough postoperative pain unrelieved adequately by tramadol a patient may receive oxycodone 5mg PO every 4 hours as needed.

Subjects in both groups will receive baseline ASES Shoulder Score assessments before the block and procedure, and again in postoperative days 1-7. Additionally, a daily MBPI Short Form will be adminstered for the seven days post operation. The primary endpoint is to assess the median pain score on POD 1 using the MBPI Short form. Secondary endpoints include Cumulative Area Under Curve (AUC) median pain score on POD1-3, opioid consumption through POD3, satisfaction with pain treatment, block duration, success rate, amount of analgesia/sedation used for it; and adverse effects attributed to either the block or catheter, and functionality of the surgical arm.

Enrollment

48 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Adult patients ≥ 18 years
Individuals presenting for major shoulder arthroscopy procedures at Ambulatory Services Center (Outpatient Surgery Center) -that include rotator cuff repair and biceps tenodesis
Patient is able to provide informed consent to participate in the study.

Exclusion criteria

Allergy to amide local anesthetic, liposomal bupivacaine or other medication involving liposomal formulation
Preexisting neurological deficits involving or potentially involving the ipsilateral brachial plexus
Preexisting contralateral vocal fold paralysis or recurrent laryngeal paralysis
Psychiatric or cognitive disorders that could interfere with perioperative evaluation including drug or alcohol abuse
Chronic pain conditions
Preoperative opioid consumption greater than 20 mg oral morphine equivalent.
Any contraindication to interscalene nerve block including any local disorder of the skin where blockade is to be performed which would prevent safe performance of the block
Any coagulation abnormality which would be a contraindication for block placement
Preoperative chronic renal dysfunction requiring renal replacement therapy or a serum creatinine greater than 1.4 mg/dL
Body mass index >50
Pregnancy
Incarceration
ASA classification greater than 3
Inability to provide informed consent