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Bupivacaine Liposomal Injectable Suspension, Pain and Narcotic Use After Elective Orthognathic Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03318757
Recruitment Status : Withdrawn (The research could not be conducted as it was denied by the IRB.)
First Posted : October 24, 2017
Last Update Posted : June 11, 2020
Sponsor:
Information provided by (Responsible Party):
Boston University

Brief Summary:

This research is being done to determine quantitative and qualitative differences in patients' post-operative pain levels following elective orthognathic surgery after the local administration of a liposomal bupivacaine injection.

A primary objective is to determine whether using a liposomal bupivacaine injection placed locally at the conclusion of elective orthognathic surgery will decrease pain levels (as determined by VAS scores). A secondary objective is to examine whether using a long acting liposomal bupivacaine injection locally at the conclusion of elective orthognathic surgery leads to decreased use of narcotics post-operatively.


Condition or disease Intervention/treatment Phase
Orthognathic Surgery Drug: Bupivacaine Extended Release Liposome Injection Drug: Bupivacaine HCl Phase 4

Detailed Description:

Participants in Group 1 (study group) will receive ExparelTM (133 mg/10 ml - 4 ml into the maxilla, and 6 ml into the mandible). This will be injected into the soft tissue and gingiva surrounding the surgical site at the time of wound closure. Participants in Group 2 (standard of care) will receive bupivacaine 0.5% (4 ml into the maxilla, and 6 ml into the mandible) injected into the soft tissue and gingiva surrounding the surgical site at the time of wound closure.

Post-operatively, all participants will be cared for utilizing the current standard post-operative pain management protocol for all patients undergoing elective orthognathic surgery at Boston Medical Center. This consists of acetaminophen 325 mg given every 4 hours as a scheduled medication; patients also receive an additional 325 mg of acetaminophen for a reported pain level of 1-3, 5 mg of oxycodone for a reported pain level of 4-6, and 10 mg of oxycodone for a reported pain level of 7-10. All participants will be provided the same methods of postoperative pain control following their elective orthognathic surgery.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Does Bupivacaine Liposomal Injectable Suspension Decrease Post-operative Pain and Narcotic Use After Elective Orthognathic Surgery?
Estimated Study Start Date : September 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 1- Bupivacaine extended release liposome injection
Bupivacaine extended release liposome injection (Exparel TM) is a novel formulation of bupivacaine designed to achieve long-acting postoperative analgesia.
Drug: Bupivacaine Extended Release Liposome Injection
Bupivacaine Extended Release Liposome Injection (Exparel TM) 133 mg diluted in 10ml of normal saline (13.3 mg/ml) will be injected with a 25 gauge needle directly into the gingiva surrounding the surgical site at the conclusion of surgery.
Other Name: Exparel TM

Active Comparator: Group 2- Bupivacaine HCl
Bupivacaine HCl (Marcaine) is a local anesthetic that reduces the flow of sodium in and out of nerves which decreases the initiation and transfer of nerve signals in the area in which the drug is applied.
Drug: Bupivacaine HCl
10ml of Bupivacaine HCl 0.5% will be injected with a 25 gauge needle directly into the gingiva surrounding the surgical site at the conclusion of surgery.
Other Name: Marcaine




Primary Outcome Measures :
  1. Change in Post operative pain [ Time Frame: 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 72, and 96 hours after surgery ]
    After surgery, participants will document in a pain journal what their pain level is based on a smiley face visual analog scale (VAS) from 0-10, where 0='no pain' and 10='worst possible, unbearable, excruciating pain'. They will rate their pain using the VAS 14 times - every 4 hours the first 48 hours and then at 72 and 96 hours post surgery. Higher scores are associated with more severe pain. The participant will return the pain journal at their post operative assessment visit.


Secondary Outcome Measures :
  1. Post operative narcotic use [ Time Frame: daily up to the 2 week post surgical visit ]
    The time and dosage of narcotics used in the postoperative period will be documented in the participants' medical record records while hospitalized and documented in the participants' pain journal once discharged. The data from the medical records and pain journal will be used to assess total narcotic pain use.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • males and females 18-40 years of age undergoing elective double jaw orthognathic surgery

Exclusion Criteria:

  • pregnancy
  • known hypersensitivity to any local anesthetic

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): NCT03318757


Locations
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United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston University
Investigators
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Principal Investigator: Pushkar Mehra, BDS DMD BU Henry M. Goldman School of Dental Medicine
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Responsible Party: Boston University
ClinicalTrials.gov Identifier: NCT03318757    
Other Study ID Numbers: H-36862
First Posted: October 24, 2017    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Boston University:
bupivacaine liposomal injectable
post operative pain
post operative narcotic use
bupivacaine hydrochloride
Additional relevant MeSH terms:
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Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents