Clinical trials: Bupivacaine
Bunionectomy, Hallux Valgus
Phase 3, Sciatic Nerve Block With EXPAREL for Subjects Undergoing Bunionectomy
The study is conducted sequentially in two parts. Part A: The purpose is to obtain information on pharmacokinetic (PK) profile, pharmacodynamics (PD), efficacy, safety, and to assess the performance of 266 mg EXPAREL vs 133 mg…
- Trial name
- NCT05157841
- Testing
- Bupivacaine liposome injectable suspension 266 mg, Bupivacaine HCl, Bupivacaine liposome injectable suspension 133 mg
- Where
- 7 sites in United States
- Volunteers
- 185 people
- Sponsor
- Pacira Pharmaceuticals, Inc
Pain
EXPAREL Infiltration in Subjects Undergoing Femoral Nerve Block With Bupivacaine HCl for Total Knee Arthroplasty
The purpose of this study is to evaluate the safety and pharmacokinetics of EXPAREL in subjects who undergo femoral nerve block with bupivacaine HCl for unilateral total knee arthroplasty (TKA).
- Trial name
- NCT02255500
- Testing
- Bupivacaine FNB, EXPAREL Infiltration
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- Pacira Pharmaceuticals, Inc
Local Analgesia Via Infiltration
A Study of Bupivacaine Liposome Injection in Local Analgesia of Pediatric Patients
The study is being conducted to evaluate the safety and efficacy of bupivacaine liposome injection for local infiltration analgesia in pediatric orthopedic surgery in the real world.
- Trial name
- NCT06344091
- Testing
- Bupivacaine Liposome Injection
- Where
- China
- Volunteers
- 232 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Pain, Postoperative, Hernia, Ventral
An Open-label Safety and Pharmacokinetic Study of INL-001 in Adults Following Various Open Soft-Tissue Surgeries
This is a multicenter, Phase 3, open-label, safety, tolerability, and characterization of pharmacokinetics study of the INL 001 (bupivacaine HCl) implant, at 300 mg, in patients following various soft-tissue surgeries: open…
- Conditions
- Pain, Postoperative, Hernia, Ventral, Abdominoplasty, Hysterectomy
- Trial name
- NCT04785638
- Testing
- INL-001 (bupivacaine hydrochloride) implant
- Where
- 8 sites in United States
- Volunteers
- 100 people
- Sponsor
- Innocoll
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
Postoperative Local Analgesia
A Study on the Bioequivalence of Bupivacaine Liposome Injection in Humans
This study aims to investigate the pharmacokinetics of bupivacaine liposomal injection (test preparation) in healthy subjects. The manufactured liposomal bupivacaine injection (EXPAREL®) was used as the reference formulation to…
- Trial name
- NCT07279155
- Testing
- Bupivacaine Liposome Injection T preparation, Bupivacaine Liposome Injection R preparation
- Where
- China
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Post Operative Pain
Trial of Extended Release Bupivacaine for Pain Relief After Surgery
This is a research study of SABER® -Bupivacaine, an experimental medication designed to reduce pain for up to 3 days after surgery.
- Trial name
- PERSIST (NCT02574520)
- Testing
- SABER-Bupivacaine (Part 1), SABER-Bupivacaine (Part 2), Bupivacaine HCl
- Where
- 21 sites in United States
- Volunteers
- 399 people
- Sponsor
- Durect
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
Postoperative Pain, Inguinal Hernia
Efficacy, Safety and Pharmacokinetic Profile of a Collagen Bupivacaine Implant in Men After Open Mesh Herniorrhaphy
The purpose of this study is to determine whether the CollaRx Bupivacaine implant is safe and effective in reducing the amount of narcotic pain medication needed to control pain during the first 24 hours after herniorrhaphy.
- Trial name
- NCT00626886
- Testing
- Bupivacaine Collagen Sponge
- Where
- United States
- Volunteers
- 53 people
- Sponsor
- Innocoll
Postoperative Pain, Hernia
A Safety and Efficacy Study of SABER®-Bupivacaine for Pain Following Hernia Repair
This is a research study testing SABER-Bupivacaine (an experimental pain-relieving medication). SABER-Bupivacaine is designed to continuously deliver bupivacaine, a common local anesthetic, for a few days in order to treat local…
- Conditions
- Postoperative Pain, Hernia, Surgery
- Trial name
- NCT00974350
- Testing
- SABER-Bupivacaine
- Where
- 5 sites in Australia, New Zealand
- Volunteers
- 124 people
- Sponsor
- Durect
Bunion, Metatarsophalangeal Fusion
Phase 3, Randomized, Double Blinded, Active Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of EXPAREL Admixed With Bupi vs. Bupi Only Administered as Combined Sciatic and Adductor Canal Nerve Block for Postsurgical Analgesia in Lower Extremity Surgeries
This is a Phase 3, multicenter, randomized, double blinded, active controlled study in approximately 81 subjects undergoing lower extremity surgeries with combined sciatic and adductor canal nerve block.
- Conditions
- Bunion, Metatarsophalangeal Fusion, Midfoot Fusion, Hindfoot Fusion
- Trial name
- STRIDE (NCT03954639)
- Testing
- EXPAREL 13.3Mg/mL Suspension for Injection, Bupivacaine Hydrochloride
- Sponsor
- Pacira Pharmaceuticals, Inc
Postoperative Pain
Femoral Nerve Block With Liposome Bupivacaine for Postsurgical Analgesia Following Total Knee Arthroplasty
The primary objectives of Part 1 are to (1) evaluate three dose levels of liposome bupivacaine versus placebo with respect to the magnitude and duration of the analgesic effect achieved following single dose injection femoral…
- Trial name
- NCT01683071
- Testing
- EXPAREL 67 mg, EXPAREL 133 mg, EXPAREL 266 mg
- Where
- 30 sites in United States
- Volunteers
- 297 people
- Sponsor
- Pacira Pharmaceuticals, Inc
Postoperative Analgesia
Pharmacokinetic and Safety Study of HYR-PB21 vs Bupivacaine Hydrochloric Acid in Healthy Participants
This is a Phase I, randomized, single-blind, active-controlled, single-dose, parallel-group study to evaluate the safety and pharmacokinetic (PK) profile of HYR-PB21, a pamoate-formulated bupivacaine injectable, in healthy adult…
- Trial name
- NCT07717086
- Testing
- HYR-PB21， 100 mg, HYR-PB21， 200 mg, HYR-PB21， 400 mg
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Fruithy Holdings Limited
Cesarean Delivery
Comparative Mixture of Non-racemic and Racemic Enantiomers of Bupivacaine in Cesarean
The purpose of this study is to determine if the mixture of enantiomers of bupivacaine (bupivacaine S75:R25) dos not represent inferiority efficacy and safety compare to the racemic mixture of enantiomers of bupivacaine…
- Trial name
- NCT01303107
- Testing
- Bupivacaine
- Where
- 2 sites in Brazil
- Volunteers
- healthy volunteers welcome
- Sponsor
- Cristália Produtos Químicos Farmacêuticos Ltda.
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
Postoperative Pain
EXPAREL Administered Into the TAP for Analgesia in Subjects Undergoing Open Total Abdominal Hysterectomy
The primary objective of this study is to determine the optimal of two different volumes of EXPAREL 266 mg when administered via infiltration into the transversus abdominis plane (TAP) for prolonged postoperative analgesia in…
- Trial name
- NCT01919606
- Testing
- EXPAREL
- Volunteers
- 1 people
- Sponsor
- Pacira Pharmaceuticals, Inc
Pain
An Extension Trial to Evaluate Long-term Safety of SABER™-Bupivacaine for Pain Following Shoulder Surgery
This is an extension to a previous research trial testing SABER™-Bupivacaine (an experimental pain-relieving medication). The purpose of this extension trial is to assess whether treatment with SABER™-Bupivacaine or…
- Trial name
- NCT01139866
- Where
- 8 sites in Australia, New Zealand
- Volunteers
- 47 people
- Sponsor
- Durect
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
Hallux Valgus, Bunionectomy
Sciatic Nerve Block With ALX006 in Subjects Undergoing Bunionectomy
This is a Phase 2, randomized, double-blind, active-controlled, dose-escalation study evaluating the safety, pharmacokinetics, efficacy, and pharmacodynamics of ALX006, an extended-release bupivacaine formulation, administered as…
- Trial name
- NCT07574385
- Testing
- ALX006 (bupivacaine extended-release injection), Bupivacaine Hcl 0.25% Inj, Sciatic Nerve Block
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Rebel Medicine Inc
Anesthesia,Spinal
Ropivacaine Versus Bupivacaine for Spinal Anaesthesia in Patients Undergoing Unilateral Lower Limb Surgery
The purpose of this study is to compare the efficacy, duration of motor block until return to normal function in the non-operated leg after the start of injection, of ropivacaine 5 mg/ml and bupivacaine 5 mg/ml when used for…
- Trial name
- NCT00358280
- Testing
- Ropivacaine, Bupivacaine
- Where
- 5 sites in China
- Volunteers
- 220 people
- Sponsor
- AstraZeneca