Interscalene Bupivacaine With Either Liposomal Bupivacaine or Continuous Peripheral Nerve Block for Shoulder Arthroscopy
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|ClinicalTrials.gov Identifier: NCT03816982|
Recruitment Status : Enrolling by invitation
First Posted : January 25, 2019
Last Update Posted : April 1, 2021
|Condition or disease||Intervention/treatment||Phase|
|Shoulder Pain||Procedure: Single-injection bupivacaine HCl plus liposomal bupivacaine Procedure: Single-injection bupivacaine HCl plus a subsequent bupivacaine CISB||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||46 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||A randomized prospective noninferiority trial to assess the difference, if any, in median pain scores between two block methods using bupivacaine HCl and/or Liposomal bupivacaine, with the catheter method or single shot administration.|
|Masking:||None (Open Label)|
|Official Title:||Single-Injection Bupivacaine HCl Plus Either Single-Injection Liposomal Bupivacaine Interscalene Nerve Block or a Continuous Interscalene Nerve Block For Major Shoulder Arthroscopy|
|Actual Study Start Date :||October 11, 2019|
|Estimated Primary Completion Date :||December 30, 2022|
|Estimated Study Completion Date :||June 30, 2023|
Active Comparator: Bupivacaine HCl/Bupivacaine CISB
23 patients will be enrolled to receive a single-injection bupivacaine HCL interscalene block with bupivacaine CISB added.
Procedure: Single-injection bupivacaine HCl plus a subsequent bupivacaine CISB
Patients in the bupivacaine CISB group will undergo catheter placement with ultrasound guidance only by faculty who are part of the regional anesthesia division. 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 5mL/hour postoperatively by the ON-Q pump
Experimental: Liposomal Bupivacaine Added to Interscalene Block
23 patients will be enrolled to receive a single-injection bupivacaine HCl interscalene block with liposomal bupivacaine added to same injection.
Procedure: Single-injection bupivacaine HCl plus liposomal bupivacaine
Patients in the liposomal bupivacaine with added bupivacaine HCl ISB group will be given a single injection LB ISB in the preoperative area only by faculty who are part of the regional anesthesia division. The injectate will include liposomal bupivacaine 10ml (133mg) mixed with bupivacaine HCl 0.5% 10 ml.
- Median pain score on POD1 [ Time Frame: 24 hours ]Median pain score on POD1 as measured by the MBPI Short Form
- Cumulative Area under Curve median pain score on POD1-3 [ Time Frame: 72 hours ]Median pain score on POD1-3 as measured by the MBPI Short Form
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03816982
|United States, Texas|
|UT Southwestern Medical Center|
|Dallas, Texas, United States, 75390|
|Principal Investigator:||Anthony T Machi, MD||UT Southwestern Medical Center|