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Liposome Bupivacaine for ANKLE Blocks

Primary Purpose

Hallux Valgus (Bunions)

Status
Completed
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
Liposome bupivacaine
Sponsored by
Catherine Vandepitte, M.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hallux Valgus (Bunions)

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female, at least 18 years and max 65 years of age at screening
  • Scheduled to undergo primary Scarf osteotomy for elective hallux valgus
  • American Society of Anesthesiologists (ASA) physical status 1, 2, or 3
  • Female subject must be surgically sterile or have a monogamous partner who is surgically sterile; or be at least 2 years postmenopausal; or practicing abstinence; or using an insertable, injectable, transdermal, or combination oral contraceptive approved by the FDA for greater than 2 months prior to screening and commit to the use of an acceptable form of birth control for the duration of the study and for 30 days after completion of the study
  • Able to demonstrate sensory function by exhibiting sensitivity to cold, pinprick, and light touch
  • Able to understand the English or Dutch language, purpose and risks of the study, provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations
  • Able to adhere to the study visit schedule, and complete all study assessments.

Exclusion Criteria:

  • Currently pregnant, nursing, or planning to become pregnant during the study or within 1 month after study drug administration
  • Planned concurrent surgical procedure (e.g., bilateral hallux valgus repair)
  • Concurrent painful physical condition that may require analgesic treatment (such as an NSAID or opioid) in the postsurgical period for pain that is not strictly related to hallux valgus and which may confound the postsurgical assessments (e.g., significant pain from other joints including chronic neuropathic pain, concurrent or prior contralateral knee or foot surgery)
  • Previous hallux valgus on the foot being considered for surgery
  • History of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics
  • Contraindication to bupivacaine, oxycodone, morphine, or hydromorphone
  • Chronic daily use of long-acting opioid medication or NSAIDs (except for low-dose aspirin used for cardioprotection) within 24 hours
  • Initiation of treatment with any of the following medications within 1 month of study drug administration or if the medication(s) are being given to control pain: selective serotonin reuptake inhibitors (SSRIs), selective norepinephrine reuptake inhibitors (SNRIs), gabapentin, pregabalin (Lyrica®), or duloxetine (Cymbalta®). If a subject is taking one of these medications for a reason other than pain control, he or she must be on a stable dose for at least 1 month prior to study drug administration.
  • Current use of systemic glucocorticosteroids within 1 month of study enrollment
  • Use of dexmedetomidine HCl (Precedex®) within 3 days of study drug administration
  • History of impaired kidney function, chronic respiratory disease, rheumatoid arthritis, coagulopathy, or loss of sensation in the extremities
  • Impaired kidney function (e.g., serum creatinine level >2 mg/dL [176.8 µmol/L] or blood urea nitrogen level >50 mg/dL [17.9 mmol/L]) or impaired liver function (e.g., serum aspartate aminotransferase [AST] level >3 times the upper limit of normal (ULN) or serum alanine aminotransferase [ALT] level >3 times the ULN
  • Uncontrolled anxiety, psychiatric, or neurological disorder that might interfere with study assessments
  • Any chronic neuromuscular deficit affecting the peripheral nerves or muscles of the surgical extremity
  • Any chronic condition or disease that would compromise neurological or vascular assessments
  • Suspected or known history of drug or alcohol abuse within the previous year
  • Body weight <40 kg (88 pounds) or a body mass index >44 kg/m2
  • Previous participation in an EXPAREL study
  • Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug, whichever is longer, prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study

Sites / Locations

  • Ziekenhuis Oost-Limburg

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Sham Comparator

Arm Label

Single mixture LB & bupivacaine

Bupivacaine alone

General anesthesia

Arm Description

A single mixture of liposome bupivacaine 1.3% (5 mL) + bupivacaine 0.5% (2.5 mL) injected into the distal tibial and deep peroneal nerves

Bupivacaine 0.5% (7.5 mL) injected into the distal tibial and deep peroneal nerves

General anesthesia

Outcomes

Primary Outcome Measures

Change in current pain over the first postoperative week
Pain rating (NRS) at rest and with movement
Change in worst pain over the first postoperative week
Modified BRIEF Pain Inventory (Q1)

Secondary Outcome Measures

Opioid consumption
Self-reported consumption of Tramadol tablets
Change in ability to use foot
Stand with equal weight on both feet, wiggle toes, walk 10 steps
Change in sleep quality
Duration (h), quality rating (0 - 10)
Change in satisfaction with pain control
With pain control (0 - 10)
Change in sensory response in skin dermatomes
Cold, pinprick, light touch in the distal tibial and deep peroneal nerve dermatomes
Change in motor response in foot
Plantar flexion, dorsiflexion

Full Information

First Posted
March 24, 2017
Last Updated
September 9, 2020
Sponsor
Catherine Vandepitte, M.D.
Collaborators
Pacira Pharmaceuticals, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT03106545
Brief Title
Liposome Bupivacaine for ANKLE Blocks
Official Title
Ultrasound-guided Specific Blocks of the Distal Tibial and Deep Peroneal Nerves at the Level of the Ankle With a Mixture of Bupivacaine + Liposome Bupivacaine v Bupivacaine Alone v General Anesthesia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
January 2, 2017 (Actual)
Primary Completion Date
June 26, 2017 (Actual)
Study Completion Date
October 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Catherine Vandepitte, M.D.
Collaborators
Pacira Pharmaceuticals, Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Postoperative analgesia for hallux valgus surgery (bunionectomy) is inconsistent and may even result in rebound pain when the (ankle) blocks wear off. It is hypothesized that the mixture of bupivacaine and liposome bupivacaine increases the extent and duration of postoperative analgesia and decreases opioid consumption as compared to bupivacaine alone or to general anesthesia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hallux Valgus (Bunions)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single mixture LB & bupivacaine
Arm Type
Experimental
Arm Description
A single mixture of liposome bupivacaine 1.3% (5 mL) + bupivacaine 0.5% (2.5 mL) injected into the distal tibial and deep peroneal nerves
Arm Title
Bupivacaine alone
Arm Type
Active Comparator
Arm Description
Bupivacaine 0.5% (7.5 mL) injected into the distal tibial and deep peroneal nerves
Arm Title
General anesthesia
Arm Type
Sham Comparator
Arm Description
General anesthesia
Intervention Type
Drug
Intervention Name(s)
Liposome bupivacaine
Primary Outcome Measure Information:
Title
Change in current pain over the first postoperative week
Description
Pain rating (NRS) at rest and with movement
Time Frame
From baseline (before nerve block) through first postoperative week
Title
Change in worst pain over the first postoperative week
Description
Modified BRIEF Pain Inventory (Q1)
Time Frame
From discharge from PACU through first postoperative week
Secondary Outcome Measure Information:
Title
Opioid consumption
Description
Self-reported consumption of Tramadol tablets
Time Frame
From hospital discharge through first postoperative week
Title
Change in ability to use foot
Description
Stand with equal weight on both feet, wiggle toes, walk 10 steps
Time Frame
From discharge from PACU through first postoperative week
Title
Change in sleep quality
Description
Duration (h), quality rating (0 - 10)
Time Frame
From discharge from PACU through first postoperative week
Title
Change in satisfaction with pain control
Description
With pain control (0 - 10)
Time Frame
From discharge from PACU through first postoperative week
Title
Change in sensory response in skin dermatomes
Description
Cold, pinprick, light touch in the distal tibial and deep peroneal nerve dermatomes
Time Frame
From premedication through first postoperative week
Title
Change in motor response in foot
Description
Plantar flexion, dorsiflexion
Time Frame
From premedication through first postoperative week
Other Pre-specified Outcome Measures:
Title
Total number of participants with side effects to regional anesthesia peripheral nerve blockade
Description
Nausea, vomiting, fever, constipation, severe itching of the skin, dizziness, sleepless nights, excessive sweating, urinary retention, headache, heart palpitations
Time Frame
From beginning of nerve block through first postoperative week
Title
Participants with adverse events
Description
Any untoward medical occurrence (unfavorable and/or unintended change in a body structure or body function) associated with the use of a drug in humans, whether or not considered drug related
Time Frame
From date of signing ICF through first postoperative week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female, at least 18 years and max 65 years of age at screening Scheduled to undergo primary Scarf osteotomy for elective hallux valgus American Society of Anesthesiologists (ASA) physical status 1, 2, or 3 Female subject must be surgically sterile or have a monogamous partner who is surgically sterile; or be at least 2 years postmenopausal; or practicing abstinence; or using an insertable, injectable, transdermal, or combination oral contraceptive approved by the FDA for greater than 2 months prior to screening and commit to the use of an acceptable form of birth control for the duration of the study and for 30 days after completion of the study Able to demonstrate sensory function by exhibiting sensitivity to cold, pinprick, and light touch Able to understand the English or Dutch language, purpose and risks of the study, provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations Able to adhere to the study visit schedule, and complete all study assessments. Exclusion Criteria: Currently pregnant, nursing, or planning to become pregnant during the study or within 1 month after study drug administration Planned concurrent surgical procedure (e.g., bilateral hallux valgus repair) Concurrent painful physical condition that may require analgesic treatment (such as an NSAID or opioid) in the postsurgical period for pain that is not strictly related to hallux valgus and which may confound the postsurgical assessments (e.g., significant pain from other joints including chronic neuropathic pain, concurrent or prior contralateral knee or foot surgery) Previous hallux valgus on the foot being considered for surgery History of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics Contraindication to bupivacaine, oxycodone, morphine, or hydromorphone Chronic daily use of long-acting opioid medication or NSAIDs (except for low-dose aspirin used for cardioprotection) within 24 hours Initiation of treatment with any of the following medications within 1 month of study drug administration or if the medication(s) are being given to control pain: selective serotonin reuptake inhibitors (SSRIs), selective norepinephrine reuptake inhibitors (SNRIs), gabapentin, pregabalin (Lyrica®), or duloxetine (Cymbalta®). If a subject is taking one of these medications for a reason other than pain control, he or she must be on a stable dose for at least 1 month prior to study drug administration. Current use of systemic glucocorticosteroids within 1 month of study enrollment Use of dexmedetomidine HCl (Precedex®) within 3 days of study drug administration History of impaired kidney function, chronic respiratory disease, rheumatoid arthritis, coagulopathy, or loss of sensation in the extremities Impaired kidney function (e.g., serum creatinine level >2 mg/dL [176.8 µmol/L] or blood urea nitrogen level >50 mg/dL [17.9 mmol/L]) or impaired liver function (e.g., serum aspartate aminotransferase [AST] level >3 times the upper limit of normal (ULN) or serum alanine aminotransferase [ALT] level >3 times the ULN Uncontrolled anxiety, psychiatric, or neurological disorder that might interfere with study assessments Any chronic neuromuscular deficit affecting the peripheral nerves or muscles of the surgical extremity Any chronic condition or disease that would compromise neurological or vascular assessments Suspected or known history of drug or alcohol abuse within the previous year Body weight <40 kg (88 pounds) or a body mass index >44 kg/m2 Previous participation in an EXPAREL study Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug, whichever is longer, prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study
Facility Information:
Facility Name
Ziekenhuis Oost-Limburg
City
Genk
ZIP/Postal Code
B-3600
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

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Liposome Bupivacaine for ANKLE Blocks

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