Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 17 for:    "Bunion" | "Central Nervous System Depressants"
Previous Study | Return to List | Next Study

Pericapsular Exparel for Pain Relief in Bunionectomy and Related Procedures

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: NCT02499575
Recruitment Status : Terminated (Logistical issues prevent efficient enrollment)
First Posted : July 16, 2015
Results First Posted : May 17, 2017
Last Update Posted : May 17, 2017
Sponsor:
Information provided by (Responsible Party):
OhioHealth

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Supportive Care
Conditions Bunion
Hallux Rigidus
Interventions Drug: 0.5% ropivacaine
Drug: Exparel
Enrollment 2
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Regional Block Regional Block Plus Exparel
Hide Arm/Group Description

Group A patients will receive only a pre-operative adductor canal block with 10 mL 0.5% ropivacaine plus a popliteal block with 30 mL 0.5% ropivacaine (total block 40 mL/200 mg).

0.5% ropivacaine: Adductor block: 10 mL of 0.5% ropivacaine; popliteal block: 30 mL of 0.5% ropivacaine

Group B patients will receive the standard of care pre-operative adductor and popliteal block as described (40 mL/200 mg of 0.5% ropivacaine) in addition to a postoperative pericapsular injection of Exparel using 106 mg (8 mL, equivalent to 120 mg bupivacaine HCl), per the same total dose as provided in manufacturer recommendations.

0.5% ropivacaine: Adductor block: 10 mL of 0.5% ropivacaine; popliteal block: 30 mL of 0.5% ropivacaine

Exparel: 106 mg (8 mL, equivalent to 120 mg bupivacaine HCl)

Period Title: Overall Study
Started 1 1
Completed 1 0
Not Completed 0 1
Reason Not Completed
Protocol Violation             0             1
Arm/Group Title Regional Block Regional Block Plus Exparel Total
Hide Arm/Group Description

Group A patients will receive only a pre-operative adductor canal block with 10 mL 0.5% ropivacaine plus a popliteal block with 30 mL 0.5% ropivacaine (total block 40 mL/200 mg).

0.5% ropivacaine: Adductor block: 10 mL of 0.5% ropivacaine; popliteal block: 30 mL of 0.5% ropivacaine

Group B patients will receive the standard of care pre-operative adductor and popliteal block as described (40 mL/200 mg of 0.5% ropivacaine) in addition to a postoperative pericapsular injection of Exparel using 106 mg (8 mL, equivalent to 120 mg bupivacaine HCl), per the same total dose as provided in manufacturer recommendations.

0.5% ropivacaine: Adductor block: 10 mL of 0.5% ropivacaine; popliteal block: 30 mL of 0.5% ropivacaine

Exparel: 106 mg (8 mL, equivalent to 120 mg bupivacaine HCl)

Total of all reporting groups
Overall Number of Baseline Participants 1 0 1
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Years
Age Number Analyzed 1 participants 0 participants 1 participants
62 62
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 0 participants 1 participants
Female
0
   0.0%
0
   0.0%
Male
1
 100.0%
1
 100.0%
1.Primary Outcome
Title Opioid Use as Measured by Questionnaire
Hide Description Compare time to first opioid use over 72 hours between groups
Time Frame Daily through the third day (72 hours) post-surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Regional Block Regional Block Plus Exparel
Hide Arm/Group Description:

Group A patients will receive only a pre-operative adductor canal block with 10 mL 0.5% ropivacaine plus a popliteal block with 30 mL 0.5% ropivacaine (total block 40 mL/200 mg).

0.5% ropivacaine: Adductor block: 10 mL of 0.5% ropivacaine; popliteal block: 30 mL of 0.5% ropivacaine

Group B patients will receive the standard of care pre-operative adductor and popliteal block as described (40 mL/200 mg of 0.5% ropivacaine) in addition to a postoperative pericapsular injection of Exparel using 106 mg (8 mL, equivalent to 120 mg bupivacaine HCl), per the same total dose as provided in manufacturer recommendations.

0.5% ropivacaine: Adductor block: 10 mL of 0.5% ropivacaine; popliteal block: 30 mL of 0.5% ropivacaine

Exparel: 106 mg (8 mL, equivalent to 120 mg bupivacaine HCl)

Overall Number of Participants Analyzed 1 0
Measure Type: Number
Unit of Measure: hours
6
2.Primary Outcome
Title Total Opioid Use as Measured by Questionnaire
Hide Description Compare total opioid use (reported as total morphine equivalents) over 72 hours between groups.
Time Frame Daily through the third day (72 hours) post-surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Regional Block Regional Block Plus Exparel
Hide Arm/Group Description:

Group A patients will receive only a pre-operative adductor canal block with 10 mL 0.5% ropivacaine plus a popliteal block with 30 mL 0.5% ropivacaine (total block 40 mL/200 mg).

0.5% ropivacaine: Adductor block: 10 mL of 0.5% ropivacaine; popliteal block: 30 mL of 0.5% ropivacaine

Group B patients will receive the standard of care pre-operative adductor and popliteal block as described (40 mL/200 mg of 0.5% ropivacaine) in addition to a postoperative pericapsular injection of Exparel using 106 mg (8 mL, equivalent to 120 mg bupivacaine HCl), per the same total dose as provided in manufacturer recommendations.

0.5% ropivacaine: Adductor block: 10 mL of 0.5% ropivacaine; popliteal block: 30 mL of 0.5% ropivacaine

Exparel: 106 mg (8 mL, equivalent to 120 mg bupivacaine HCl)

Overall Number of Participants Analyzed 1 0
Measure Type: Number
Unit of Measure: morphine equivalents
18
3.Secondary Outcome
Title Pain Relief Measured by Defense and Veterans Pain Scale
Hide Description Evaluate patient-reported pain scores (scale of 0 (no pain) - 10 (worst pain)) at 0, 6, 12, 24, 36, 48, 60, and 72 hours following surgery
Time Frame Through 72 hours post-surgery (0, 6, 12, 24, 36, 48, 60, and 72 hours post-surgery)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Regional Block Regional Block Plus Exparel
Hide Arm/Group Description:

Group A patients will receive only a pre-operative adductor canal block with 10 mL 0.5% ropivacaine plus a popliteal block with 30 mL 0.5% ropivacaine (total block 40 mL/200 mg).

0.5% ropivacaine: Adductor block: 10 mL of 0.5% ropivacaine; popliteal block: 30 mL of 0.5% ropivacaine

Group B patients will receive the standard of care pre-operative adductor and popliteal block as described (40 mL/200 mg of 0.5% ropivacaine) in addition to a postoperative pericapsular injection of Exparel using 106 mg (8 mL, equivalent to 120 mg bupivacaine HCl), per the same total dose as provided in manufacturer recommendations.

0.5% ropivacaine: Adductor block: 10 mL of 0.5% ropivacaine; popliteal block: 30 mL of 0.5% ropivacaine

Exparel: 106 mg (8 mL, equivalent to 120 mg bupivacaine HCl)

Overall Number of Participants Analyzed 1 0
Measure Type: Number
Unit of Measure: units on scale of 0 -10
Pain score time 0 0
Pain score time 6hrs 3
Pain score time 12hrs 3
Pain score time 24hrs 2
Pain score time 36hrs 3
Pain score time 48hrs 3
Pain score time 60hrs 2
Pain score time 72hrs 2
Time Frame up to 30 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Regional Block Regional Block Plus Exparel
Hide Arm/Group Description

Group A patients will receive only a pre-operative adductor canal block with 10 mL 0.5% ropivacaine plus a popliteal block with 30 mL 0.5% ropivacaine (total block 40 mL/200 mg).

0.5% ropivacaine: Adductor block: 10 mL of 0.5% ropivacaine; popliteal block: 30 mL of 0.5% ropivacaine

Group B patients will receive the standard of care pre-operative adductor and popliteal block as described (40 mL/200 mg of 0.5% ropivacaine) in addition to a postoperative pericapsular injection of Exparel using 106 mg (8 mL, equivalent to 120 mg bupivacaine HCl), per the same total dose as provided in manufacturer recommendations.

0.5% ropivacaine: Adductor block: 10 mL of 0.5% ropivacaine; popliteal block: 30 mL of 0.5% ropivacaine

Exparel: 106 mg (8 mL, equivalent to 120 mg bupivacaine HCl)

All-Cause Mortality
Regional Block Regional Block Plus Exparel
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Regional Block Regional Block Plus Exparel
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/1 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Regional Block Regional Block Plus Exparel
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/1 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Christopher Hyer
Organization: Orthopedic Foot and Ankle Center
Phone: 614-895-8747
Responsible Party: OhioHealth
ClinicalTrials.gov Identifier: NCT02499575     History of Changes
Other Study ID Numbers: OH2-15-0005
First Submitted: July 2, 2015
First Posted: July 16, 2015
Results First Submitted: November 30, 2016
Results First Posted: May 17, 2017
Last Update Posted: May 17, 2017