A Phase 4, Randomized, Blinded, Active-Controlled Study of HTX-011 in Subjects Undergoing Different Surgical Procedures, Cohort 2: Abdominoplasty

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Record identity and dates

Source

ClinicalTrials.gov

Source record ID

NCT06109428

Title field or adapter rule

{'original_value': 'A Phase 4, Randomized, Blinded, Active-Controlled Study of HTX-011 in Subjects Undergoing Different Surgical Procedures, Cohort 2: Abdominoplasty', 'source_field': 'protocolSection.identificationModule.officialTitle'}

Ingested At

2026-10-29T01:00:17.534842+00:00

Published At

2026-10-28T00:00:00+00:00

Record Updated At

2026-10-28

Results Posted At

2026-10-28

Source Retrieved At

2026-10-29T01:00:16.864611+00:00

Timestamp Basis

ClinicalTrials.gov API/RSS response retrieval timestamp recorded by Dossier adapter

Date limitation

ClinicalTrials.gov API/RSS response retrieval timestamp recorded by Dossier adapter

Fields recorded by this source

protocolSection.conditionsModule.conditions

["Postoperative Pain", "Abdominoplasty Surgery", "Multimodal Analgesia"]

protocolSection.statusModule.lastUpdatePostDateStruct

{"date": "2026-10-28", "type": "ACTUAL"}

protocolSection.identificationModule.nctId

"NCT06109428"

protocolSection.identificationModule.officialTitle

"A Phase 4, Randomized, Blinded, Active-Controlled Study of HTX-011 in Subjects Undergoing Different Surgical Procedures, Cohort 2: Abdominoplasty"

protocolSection.statusModule.overallStatus

"COMPLETED"

protocolSection.designModule.phases

["PHASE4"]

protocolSection.statusModule.resultsFirstPostDateStruct

{"date": "2026-10-28", "type": "ACTUAL"}

Study condition terms

• Postoperative Pain (protocolSection.conditionsModule.conditions)
• Abdominoplasty Surgery (protocolSection.conditionsModule.conditions)
• Multimodal Analgesia (protocolSection.conditionsModule.conditions)

Interventions recorded in this study

• {'armGroupLabels': ['Bupivacaine HCl + MMA', 'HTX-011 + MMA'], 'description': 'acetaminophen 1 g every 8 hours (q8h) and ibuprofen 400 mg q8h, alternating the 2 medications so that an analgesic was taken approximately every 4 hours (q4h)', 'name': 'MMA regimen', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
• {'armGroupLabels': ['HTX-011 + MMA'], 'description': 'ZYNRELEF kits include sterile, individually packaged components for administration, including vented vial spikes, Luer lock syringes, custom Luer lock applicators, and syringe tip caps.', 'name': 'ZYNRELEF kit components for administration', 'type': 'DEVICE'} (protocolSection.armsInterventionsModule.interventions[])
• {'armGroupLabels': ['HTX-011 + MMA'], 'description': 'HTX-011 (bupivacaine/meloxicam) extended-release solution for instillation use, supplied in commercially available ZYNRELEF kits', 'name': 'HTX-011', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
• {'armGroupLabels': ['Bupivacaine HCl + MMA'], 'description': 'Bupivacaine HCl (without epinephrine) 0.25%', 'name': 'Bupivacaine Hydrochloride', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])

An intervention appearing in a study record does not establish an effect or an approved use.

Drug names recorded in this source

• MMA regimen (protocolSection.armsInterventionsModule.interventions[].name)
• HTX-011 (protocolSection.armsInterventionsModule.interventions[].name)
• Bupivacaine Hydrochloride (protocolSection.armsInterventionsModule.interventions[].name)

A recorded drug name is not by itself an indication or a condition-specific relationship.

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