Pericapsular Exparel for Pain Relief in Bunionectomy and Related Procedures

• Sponsor: OhioHealth (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02499575
• Collaborator: (none)
• Enrollment: 2
• Locations: 2
• Arms: 2
• Duration (Months): 12
• Patient Per Site: 1
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

Exparel is an FDA-approved local anesthetic (bupivacaine), in a long-release formulation. In this study the investigators plan to determine the ability of Exparel to control post-operative pain in common first metatarsophalangeal (MTP) joint procedures (bunion surgery, 1st MTP fusion, and cheilectomy).

Condition or Disease	Intervention/Treatment	Phase
Bunion; Hallux Rigidus	Drug: 0.5% ropivacaine; Drug: Exparel	N/A

Detailed Description

The investigators propose a prospective, randomized, single-blinded study of patients who are electing to undergo an outpatient first metatarsophalangeal (MTP) joint procedure (bunionectomy, 1st MTP fusion, or cheilectomy). As a standard, patients undergoing these procedures are given regional anesthesia (adductor canal block plus popliteal block). Patients are then given prescriptions for oral opioids to manage post-operative pain. The purpose of this study is to determine whether a single intrapopliteal administration of Exparel, in conjunction with the standard of care regional block, improves pain relief and therefore decreases use of post-operative opioids.

Study Design

• Study Type: Interventional
• Actual Enrollment: 2 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Supportive Care
• Official Title: Exparel Pericapsular Injection: A Prospective Evaluation of Postoperative Pain in Bunion Surgery, First Metatarsophalangeal Joint Fusion, and Cheilectomy
• Study Start Date: Jul 1, 2015
• Actual Primary Completion Date: Jan 1, 2016
• Actual Study Completion Date: Jul 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Regional Block 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).	Drug: 0.5% ropivacaine; Adductor block: 10 mL of 0.5% ropivacaine; popliteal block: 30 mL of 0.5% ropivacaine; Other Names: ropivacaine
Experimental: Regional Block Plus Exparel 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.	Drug: 0.5% ropivacaine; Adductor block: 10 mL of 0.5% ropivacaine; popliteal block: 30 mL of 0.5% ropivacaine; Other Names: ropivacaine ; Drug: Exparel; 106 mg (8 mL, equivalent to 120 mg bupivacaine HCl); Other Names: Liposomal bupivacaine

Outcome Measures

Primary Outcome Measures

1. Opioid Use as Measured by Questionnaire [Daily through the third day (72 hours) post-surgery]

   Compare time to first opioid use over 72 hours between groups

2. Total Opioid Use as Measured by Questionnaire [Daily through the third day (72 hours) post-surgery]

   Compare total opioid use (reported as total morphine equivalents) over 72 hours between groups.

Secondary Outcome Measures

1. Pain Relief Measured by Defense and Veterans Pain Scale [Through 72 hours post-surgery (0, 6, 12, 24, 36, 48, 60, and 72 hours post-surgery)]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age ≥ 18

• Undergoing distal or midshaft osteotomy for bunion correction, 1st MTP Fusion, or cheilectomy

Exclusion Criteria:

• Age less than 18

• Unable to read/write English

• Dementia, history of dementia, or other significant mental impairment that would, in the opinion of the investigator, impede patient self-reporting

• Weight <70 kg

• Allergy to local anesthetics

• History of long-acting opioid use or opioid tolerance (any patient receiving at least 30 mg of oxycodone or equivalent per day (e.g., 6 tabs of Percocet 5/325 mg) regularly for approximately 7 days or more OR who require increased analgesic doses for a period long enough to develop tolerance to the effects of the opioid including analgesia and sedation)

• Any history of opioid misuse, illicit or prescription

• Prior MTP joint correction on the surgical limb

• Midfoot and hindfoot procedures performed concurrently, on the same day

• Pregnant or breastfeeding

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Grant Medical Center	Columbus	Ohio	United States	43215
2	Orthopedic Foot and Ankle Center	Westerville	Ohio	United States	43082

Sponsors and Collaborators

• OhioHealth

Investigators

• Principal Investigator: Christopher Hyer, DPM, OhioHealth

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: OhioHealth
• ClinicalTrials.gov Identifier: NCT02499575
• Other Study ID Numbers: OH2-15-0005
• First Posted: Jul 16, 2015
• Last Update Posted: May 17, 2017
• Last Verified: Jul 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by OhioHealth: Exparel; bupivacaine; Hallux valgus deformity; bunionectomy
• Additional relevant MeSH terms: Bunion; Hallux Rigidus; Hallux Limitus; Bupivacaine; Ropivacaine

Study Results

Participant Flow

Arm/Group Title	Regional Block	Regional Block Plus Exparel
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

Baseline Characteristics

Arm/Group Title	Regional Block	Regional Block Plus Exparel	Total
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 Participants	1	0	1
Age, Customized (years) [Number]
Age	62	62
Sex: Female, Male (Count of Participants)
Female	0 0%	0 NaN
Male	1 100%	1 Infinity

Outcome Measures

1. Primary Outcome

Title	Opioid Use as Measured by Questionnaire
Description	Compare time to first opioid use over 72 hours between groups
Time Frame	Daily through the third day (72 hours) post-surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Regional Block	Regional Block Plus Exparel
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)
Measure Participants	1	0
Number [hours]	6

2. Primary Outcome

Title	Total Opioid Use as Measured by Questionnaire
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Regional Block	Regional Block Plus Exparel
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)
Measure Participants	1	0
Number [morphine equivalents]	18

3. Secondary Outcome

Title	Pain Relief Measured by Defense and Veterans Pain Scale
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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Regional Block	Regional Block Plus Exparel
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)
Measure Participants	1	0
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

Adverse Events

Time Frame	up to 30 days
Arm/Group Title	Regional Block		Regional Block Plus Exparel
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Regional Block		Regional Block Plus Exparel
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1 (0%)		0/1 (0%)
Other (Not Including Serious) Adverse Events
	Regional Block		Regional Block Plus Exparel
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1 (0%)		0/1 (0%)

Limitations/Caveats

[Not Specified]

More Information

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.