Clinical trials: Local Infiltration
Bowel Obstruction
A Health Economic Trial in Adult Patients Undergoing Open Colectomy MA402S23B302
This study is designed to compare the standard of care against EXPAREL (bupivacaine liposome extended-release injectable suspension) to determine if total opioid consumption is reduced when using EXPAREL, therefore possibly…
- Trial name
- IMPROVE-Open (NCT01507233)
- Testing
- IV morphine sulfate, EXPAREL (bupivacaine liposome injectable suspension)
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Pacira Pharmaceuticals, Inc
Hernioplasty
Pharmacokinetics, Relative Bioavailability and Safety of Xaracoll Implant
Assess the pharmacokinetic profile of 2 doses of the XaraColl® implant after open laparotomy hernioplasty and assess the relative bioavailability of Xaracoll compared to a local bupivacaine infiltration.
- Trial name
- NCT02232178
- Testing
- 2 100mg Xaracoll implants, 3 100mg Xaracoll implants, 150mg Bupivacaine HCl injection
- Where
- 5 sites in United States
- Volunteers
- 64 people
- Sponsor
- Innocoll
Healthy Volunteers
Safety and Pharmacokinetics Study of Redosing EXPAREL in Healthy Volunteers
The purpose of this study is to evaluate the safety and pharmacokinetics of redosing EXPAREL via local subcutaneous infiltration in healthy volunteers.
- Trial name
- NCT02210247
- Testing
- EXPAREL
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Pacira Pharmaceuticals, Inc
Infiltration of Peripheral IV Therapy
ivWatch Model 400: Device Validation for Infiltrated Tissues
A single arm trial consisting of 70 adult volunteers to assess the safety and efficacy of the ivWatch Model 400 when observing infiltrated tissues at common sites for peripheral IV therapy.
- Trial name
- NCT02123745
- Testing
- The ivWatch Model 400
- Where
- United States
- Volunteers
- 71 people, healthy volunteers welcome
- Sponsor
- ivWatch, LLC
Pain
Evaluation of the Safety and Efficacy of EXPAREL When Administered Into the TAP in Subjects Undergoing Cesarean Section
This is a Phase 4, multicenter, open-label study evaluating EXPAREL infiltration into the transversus abdominis plane (TAP) after bupivacaine hydrochloride (HCl) spinal anesthesia in subjects undergoing elective Cesarean section…
- Trial name
- NCT02353754
- Testing
- Intrathecal morphine injection, EXPAREL
- Where
- 5 sites in United States
- Volunteers
- 12 people
- Sponsor
- Pacira Pharmaceuticals, Inc
Caries,Dental
Clinical Trial Proximal Caries Infiltration and Detection
The purpose of this study is to investigate the clinical efficacy of resin infiltration (Icon, DMG, Germany) compared to fluoride varnish (Duraphat Fluoride Varnish, Colgate, USA) in the management of proximal early caries…
- Trial name
- NCT01796106
- Testing
- Resin infiltration, Fluoride varnish & Oral hygiene instruction
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- DMG Dental Material Gesellschaft mbH
Mammoplasty, Postoperative Pain
Study of EXPAREL in Patients Undergoing Breast Augmentation
This is a Phase 4, prospective, open-label, non-randomized, sequential study with two treatment groups differing only in the technique used for EXPAREL administration (instillation or infiltration).
- Trial name
- NCT01582490
- Testing
- Instillation - EXPAREL, Infiltration - EXPAREL
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- Pacira Pharmaceuticals, Inc
Infiltration of Peripheral IV Therapy
Optical Detection of Intravenous Infiltration:A Pilot Study
This study will examine the use of the ivWatch Model 400 to monitor PIV sites in pediatric patients. Half the participants will be monitored by the device without infiltration notifications and the other half will be monitored by…
- Trial name
- NCT02553421
- Testing
- ivWatch Model 400
- Where
- United States
- Volunteers
- 243 people
- Sponsor
- ivWatch, LLC
C-Section, Pain Management
Evaluate the Safety and Efficacy of EXPAREL When Administered Via Infiltration Into the TAP vs. Bupivacaine Alone in Subjects Undergoing Elective C-Sections
Primary objective: The primary objective of this study is to compare total opioid consumption through 72 hours following EXPAREL+bupivacaine HCl infiltration into the transversus abdominis plane (TAP) after spinal anesthesia to…
- Trial name
- C-Section (NCT03176459)
- Testing
- Exparel + Bupivacaine, Bupivacaine
- Where
- 12 sites in United States
- Volunteers
- 186 people, healthy volunteers welcome
- Sponsor
- Pacira Pharmaceuticals, Inc
Elective Cesarean Section, Pain Management
Efficacy and Safety of EXPAREL Versus Standard of Care (SoC) in Subjects Undergoing Elective Cesarean Section
The purpose of this study is to compare total opioid consumption by subjects in different treatment groups. Another purpose of this study is to assess how well EXPAREL works, collect any safety data and assess your satisfaction…
- Trial name
- CHOICE (NCT03853694)
- Testing
- 50 mcg Duramorph+ EXPAREL + multi-modal pain regimen, 150 mcg Duramorph + multi-modal pain regimen, Exparel TAP + multi-modal pain regimen
- Where
- 18 sites in United States
- Volunteers
- 167 people
- Sponsor
- Pacira Pharmaceuticals, Inc
Retraction of Colostomy
A Health Economic Trial in Adult Patients Undergoing Ileostomy Reversal MA402S23B501
This study is designed to compare the standard of care against EXPAREL (bupivacaine liposome injectable suspension) to determine if total opioid consumption is reduced when using EXPAREL, therefore possibly reducing total…
- Trial name
- IMPROVE-IR (NCT01509638)
- Testing
- Group 1 Standard of Care, Group 2 EXPAREL
- Where
- 2 sites in United States
- Volunteers
- 47 people
- Sponsor
- Pacira Pharmaceuticals, Inc
Caries Infiltration, Fluorosis
Resin Infiltration and Resin Infiltration With Bleaching in Improving the Esthetics for Fluorosis Stains
Dental fluorosis is a clinical manifestation of chronic exposure to high intakes of fluoride during the tooth development. The present study is planned to evaluate the efficacy of Resin Infiltration technique in improving the…
- Conditions
- Caries Infiltration, Fluorosis, Dental Care
- Trial name
- NCT01733888
- Testing
- Office Bleaching, Resin Infiltration, Resin Infiltration twice
- Where
- 2 sites in India
- Volunteers
- 80 people
- Sponsor
- DMG Dental Material Gesellschaft mbH
Bowel Obstruction
A Health Economic Trial in Adult Patients Undergoing Open Colectomy MA402S23B301
This study is designed to compare the standard of care against EXPAREL (bupivacaine liposome extended-release injectable suspension) to determine if total opioid consumption is reduced when using EXPAREL therefore possibly…
- Trial name
- IMPROVE-Open (NCT01507220)
- Testing
- morphine sulfate, bupivacaine liposome extended-release injectable suspension
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Pacira Pharmaceuticals, Inc
Postsurgical Pain, Analgesia
TAP-patients With Robotic Assisted Lap Prostatectomy
The purpose of the study is to assess the safety and efficacy of EXPAREL when administered via infiltration into the transversus abdominis plane (TAP) to prolonged postsurgical analgesia in men undergoing robot-assisted…
- Conditions
- Postsurgical Pain, Analgesia, Prostatectomy
- Trial name
- TAP (NCT01582477)
- Testing
- EXPAREL 20 mL, EXPAREL 40 mL
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Pacira Pharmaceuticals, Inc
Pain
EXPAREL Administered by Infiltration Into the TAP for Prolonged Postsurgical Analgesia in Lower Abdominal Surgeries
The purpose of this prospective, blinded assessor, randomized trial is to assess opioid use and patient-reported outcomes of EXPAREL as a foundation in postsurgical pain therapy in Transversus Abdominis Plane (TAP) infiltration…
- Trial name
- TRANSCEND (NCT01919190)
- Testing
- EXPAREL
- Where
- 13 sites in United States
- Volunteers
- 67 people
- Sponsor
- Pacira Pharmaceuticals, Inc
Infiltration of Peripheral IV Therapy
ivWatch Model 400: Device Validation for Non-Infiltrated Tissues
A single arm study of 40 adult volunteers to assess the safety and efficacy of the ivWatch Model 400 when observing non-infiltrated (normal) tissues at common peripheral IV therapy sites.
- Trial name
- NCT02120443
- Testing
- ivWatch Model 400
- Where
- United States
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- ivWatch, LLC
Pain
Local Infiltration Analgesia With and Without EXPAREL Following Total Knee Arthroplasty
This is a Phase 4, multicenter, randomized, double-blind, controlled trial in approximately 140 adult subjects undergoing primary unilateral TKA under spinal anesthesia with bupivacaine HCl (10-15 mg).
- Trial name
- NCT02713490
- Testing
- EXPAREL, Bupivacaine
- Where
- 17 sites in United States
- Volunteers
- 140 people
- Sponsor
- Pacira Pharmaceuticals, Inc
Hernioplasty
Pharmacokinetics, Relative Bioavailability and Safety of INL-001 Compared to Marcaine After Open Hernioplasty
This is a multicenter randomized, single-blind, controlled study. The primary objectives of this study are to obtain the pharmacokinetic profile and the relative bioavailability of the INL-001 matrix during and after open…
- Trial name
- NCT03234374
- Testing
- INL-001 (bupivacaine HCl collagen implant), Marcaine 0.25% infiltration
- Where
- 5 sites in United States
- Volunteers
- 52 people
- Sponsor
- Innocoll
Infiltration of Peripheral IV Therapy
ivWatch Sensor: Device Validation for Infiltrated Tissues
A single arm trial consisting of 98 adult volunteers to assess the safety and efficacy of ivWatch sensors when observing infiltrated tissues at common sites for peripheral IV therapy.
- Trial name
- NCT04064229
- Testing
- ivWatch Model 400 with SmartTouch Sensor, ivWatch Model 400 with Fiber Optic Sensor
- Where
- United States
- Volunteers
- 99 people, healthy volunteers welcome
- Sponsor
- ivWatch, LLC
Infiltration of Peripheral IV Therapy
Milky Way Sensor Motion Validation
A single arm study of 20 adult volunteers to assess the safety and efficacy of the ivWatch sensors when observing non-infiltrated (normal) tissues at common peripheral IV therapy sites.
- Trial name
- NCT07228416
- Testing
- ivWatch Model 400
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- ivWatch, LLC