Wound Infiltration as Part of an Opioid Free Pain Management Pathway Following Cesarean Delivery
NCT ID: NCT03545516
Last Updated: 2018-08-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2
540 participants
INTERVENTIONAL
2018-09-17
2018-11-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Management of Postoperative Pain With Preemptive Analgesia in Cesarean Section
NCT02879435
Comparison of the Application of Lidocaine With Intraperitoneal Bupivacaine in Cesarian Operations Wound Infiltration
NCT04856735
Transverse Abdominal Block for Analgesia in Casarean Section
NCT02122510
Liposomal Bupivacaine After Cesarean Delivery
NCT03907813
Transversalis Fascia Plane Blocks for Analgesia Post-cesarean Delivery
NCT03236324
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Placebo
Wound infiltration with a placebo
Placebo
Injection of a placebo into the surgical wound
Bupivacaine
Wound Infiltration with 20 mL (150mg) of 0.75% bupivacaine diluted with 5 mL of normal saline to give a 25 mL
Bupivacaine
Injection of bupivacaine into the surgical incision prior to its closure.
Bupivacaine and Dexmedetomidine
Wound Infiltration with 20 mL (150mg) of 0.75% bupivacaine and 1.5 mcg/kg of dexmedetomidine will be diluted with normal saline to make 25 mL of solution .
Bupivacaine
Injection of bupivacaine into the surgical incision prior to its closure.
Dexmedetomidine
Injection of dexmedetomidine ( an adjuvant) into the surgical incision prior to its closure.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Bupivacaine
Injection of bupivacaine into the surgical incision prior to its closure.
Dexmedetomidine
Injection of dexmedetomidine ( an adjuvant) into the surgical incision prior to its closure.
Placebo
Injection of a placebo into the surgical wound
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* Multifetal gestation
* Subjects \<18 years old
* Subjects belonging to a vulnerable population (including subjects with a known opioid addiction, subjects with a history of mental illness and prisoners)
* Cesarean delivery with general anesthesia
* Known allergy or hypersensitivity to any of the study medications
* Subjects that can't comprehend the visual analog scale for quantitative pain assessment
18 Years
55 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Richmond University Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Nisha Lakhi, MD
Research Director
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Nisha Lakhi, MD
Role: PRINCIPAL_INVESTIGATOR
Richmond University Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Richmond University Medical Center
Staten Island, New York, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Post Cesarean Pain Management
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.