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

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ClinicalTrials.gov Identifier: NCT03816982
Recruitment Status : Not yet recruiting
First Posted : January 25, 2019
Last Update Posted : June 18, 2019
Sponsor:
Information provided by (Responsible Party):
Anthony Machi, University of Texas Southwestern Medical Center

Brief Summary:
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).

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

Detailed 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 ON-Q 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: Randomized
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)
Primary Purpose: Prevention
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
Estimated Study Start Date : July 15, 2019
Estimated Primary Completion Date : January 30, 2020
Estimated Study Completion Date : March 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Median pain score on POD1 [ Time Frame: 24 hours ]
    Median pain score on POD1 as measured by the MBPI Short Form


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients ≥ 18 years
  • Individuals presenting for major shoulder arthroscopy procedures at Ambulatory Services Center (Outpatient Surgery Center) (for example: rotator cuff repair, subacromial decompression, Bankart repair)
  • 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
  • Concomitant opioid therapy
  • 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
  • Refusal to participate in the study
  • Patients undergoing biceps tenodesis (due to variable axillary pain not covered by ISB)

Information from the National Library of Medicine

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


Contacts
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Contact: Mandy M McBroom, MPH 214-645-8145 Mandy.McBroom@UTSouthwestern.edu
Contact: Anthony T Machi, MD 214-648-6400 Anthony.Machi@UTSouthwestern.edu

Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
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Principal Investigator: Anthony T Machi, MD UT Southwestern Medical Center

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Responsible Party: Anthony Machi, Assistant Professor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT03816982     History of Changes
Other Study ID Numbers: STU 082018-017
First Posted: January 25, 2019    Key Record Dates
Last Update Posted: June 18, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No study data will be shared with outside entities or non-IRB approved study personnel.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
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Shoulder Pain
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents