NCT03682302 (PLAY) is a Phase 3 clinical trial of Exparel in Postoperative Pain Management, sponsored by Pacira Pharmaceuticals, Inc.

Who is sponsoring NCT03682302?

NCT03682302 is sponsored by Pacira Pharmaceuticals, Inc.

What drugs are being tested in NCT03682302?

Interventions in NCT03682302: Exparel, 0.5% Bupivacaine HCl.

What condition does NCT03682302 study?

NCT03682302 studies Postoperative Pain Management.

Is NCT03682302 still recruiting?

NCT03682302 is currently completed. Last updated 6 January 2021.

Are results published for NCT03682302?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-01-06 · How we verify

NCT03682302: PLAY

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Multicenter Study for Pediatric Subjects Evaluating Pharmacokinetics and Safety of EXPAREL

Completed Phase 3 Results posted Last updated 6 January 2021

What this trial tests

Phase 3 trial testing Exparel in Postoperative Pain Management in 98 participants. Completed in 24 September 2019.

Timeline

2 April 2019

Primary endpoint
30 August 2019

24 September 2019

Quick facts

Lead sponsor	Pacira Pharmaceuticals, Inc
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	98
Start date	2 April 2019
Primary completion	30 August 2019
Estimated completion	24 September 2019
Sites	17 locations across United States

Drugs / interventions tested

Exparel — full drug profile →
0.5% Bupivacaine HCl

Conditions studied

Postoperative Pain Management — all drugs for Postoperative Pain Management →

Sponsor

Pacira Pharmaceuticals, Inc — full company profile →

Who can join

Adults 6 to 17, any sex, with Postoperative Pain Management. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Area Under the Plasma Concentration-versus-time Curve (AUC) 0 to Infinity Primary · 15, 30, 45 min, 1-1.25h, 2-4h, 10-18h, 24-36h, 42-60h (spine surgery) or 15, 30, 45 min, 1-1.25, 15-25, 20-40, 45-55, 64-72h (cardiac surgery)

Group	Value	95% CI
Group 1: 12 to Less Than 17 Years, Undergoing Spine Surgery, EXPAREL	14246.1	± 9118.83
Group 1: 12 to Less Than 17 Years, Undergoing Spine Surgery, Bupivacine	5709.4	± 3281.74
Group 2: 6 to Less Than 12 Years, Undergoing Spine Surgery, EXPAREL	11569.5	± 7306.07
Group 2: 6 to Less Than 12 Years, Undergoing Cardiac Surgery, EXPAREL	26164.0	± 28038.35

Maximum Plasma Concentration (Cmax) Primary · 15, 30, 45 min, 1-1.25h, 2-4h, 10-18h, 24-36h, 42-60h (spine surgery) or 15, 30, 45 min, 1-1.25, 15-25, 20-40, 45-55, 64-72h (cardiac surgery)

Group	Value	95% CI
Group 1: 12 to Less Than 17 Years, Undergoing Spine Surgery, EXPAREL	357.3	± 125.31
Group 1: 12 to Less Than 17 Years, Undergoing Spine Surgery, Bupivacine	563.6	± 320.93
Group 2: 6 to Less Than 12 Years, Undergoing Spine Surgery, EXPAREL	319.5	± 164.76
Group 2: 6 to Less Than 12 Years, Undergoing Cardiac Surgery, EXPAREL	447.1	± 243.41

The Apparent Terminal Elimination Half-life (t1/2el) Primary · 15, 30, 45 min, 1-1.25h, 2-4h, 10-18h, 24-36h, 42-60h (spine surgery) or 15, 30, 45 min, 1-1.25, 15-25, 20-40, 45-55, 64-72h (cardiac surgery)

Group	Value	95% CI
Group 1: 12 to Less Than 17 Years, Undergoing Spine Surgery, EXPAREL	26.8	± 21.26
Group 1: 12 to Less Than 17 Years, Undergoing Spine Surgery, Bupivacine	8.4	± 6.26
Group 2: 6 to Less Than 12 Years, Undergoing Spine Surgery, EXPAREL	13.4	± 4.60
Group 2: 6 to Less Than 12 Years, Undergoing Cardiac Surgery, EXPAREL	24.9	± 20.58

Apparent Clearance (CL/F) Primary · 15, 30, 45 min, 1-1.25h, 2-4h, 10-18h, 24-36h, 42-60h (spine surgery) or 15, 30, 45 min, 1-1.25, 15-25, 20-40, 45-55, 64-72h (cardiac surgery)

Group	Value	95% CI
Group 1: 12 to Less Than 17 Years, Undergoing Spine Surgery, EXPAREL	17.5	± 7.47
Group 1: 12 to Less Than 17 Years, Undergoing Spine Surgery, Bupivacine	20.5	± 8.27
Group 2: 6 to Less Than 12 Years, Undergoing Spine Surgery, EXPAREL	14.5	± 2.70
Group 2: 6 to Less Than 12 Years, Undergoing Cardiac Surgery, EXPAREL	7.4	± 3.20

Apparent Volume of Distribution (Vd/F) Primary · 15, 30, 45 min, 1-1.25h, 2-4h, 10-18h, 24-36h, 42-60h (spine surgery) or 15, 30, 45 min, 1-1.25, 15-25, 20-40, 45-55, 64-72h (cardiac surgery)

Group	Value	95% CI
Group 1: 12 to Less Than 17 Years, Undergoing Spine Surgery, EXPAREL	546.4	± 269.42
Group 1: 12 to Less Than 17 Years, Undergoing Spine Surgery, Bupivacine	226.8	± 110.63
Group 2: 6 to Less Than 12 Years, Undergoing Spine Surgery, EXPAREL	271.1	± 43.58
Group 2: 6 to Less Than 12 Years, Undergoing Cardiac Surgery, EXPAREL	216.1	± 83.77

Area Under the Plasma Concentration-versus-time Curve (AUC) 0 to Tlast Primary · 15, 30, 45 min, 1-1.25h, 2-4h, 10-18h, 24-36h, 42-60h (spine surgery) or 15, 30, 45 min, 1-1.25, 15-25, 20-40, 45-55, 64-72h (cardiac surgery)

Group	Value	95% CI
Group 1: 12 to Less Than 17 Years, Undergoing Spine Surgery, EXPAREL	9042.5	± 3762.82
Group 1: 12 to Less Than 17 Years, Undergoing Spine Surgery, Bupivacine	5232.9	± 2538.37
Group 2: 6 to Less Than 12 Years, Undergoing Spine Surgery, EXPAREL	10249.6	± 5956.56
Group 2: 6 to Less Than 12 Years, Undergoing Cardiac Surgery, EXPAREL	16776.4	± 7935.80

Adverse events — posted to ClinicalTrials.gov

Time frame: Screening through postsurgical Day 14. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Group 1: 12 to Less Than 17 Years, Undergoing Spine Surgery, EXPAREL

Serious: 0/31 (0%)

Deaths: 0/31

Group 1: 12 to Less Than 17 Years, Undergoing Spine Surgery, Bupivacaine

Serious: 0/30 (0%)

Deaths: 0/30

Group 2: 6 to Less Than 12 Years, Undergoing Spine Surgery, EXPAREL

Serious: 0/5 (0%)

Deaths: 0/5

Group 2: 6 to Less Than 12 Years, Undergoing Cardiac Surgery, EXPAREL

Serious: 2/29 (7%)

Deaths: 0/29

Serious adverse events (3 terms)

Reaction	System	Group 1: 12 to Less Than 1…	Group 1: 12 to Less Than 1…	Group 2: 6 to Less Than 12…	Group 2: 6 to Less Than 12…
Dyspnea	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—
Wound infection fungal	Infections and infestations	—	—	—	—

Other adverse events (23 terms — click to expand)

Reaction	System	Group 1: 12 to Less Than 1…	Group 1: 12 to Less Than 1…	Group 2: 6 to Less Than 12…	Group 2: 6 to Less Than 12…
Nausea	Gastrointestinal disorders	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—
Muscle twitching	Musculoskeletal and connective tissue disorders	—	—	—	—
Hypotension	Vascular disorders	—	—	—	—
Vision blurred	Eye disorders	—	—	—	—
Anemia postoperative	Injury, poisoning and procedural complications	—	—	—	—
Tachycardia	Cardiac disorders	—	—	—	—
Hypoesthesia oral	Gastrointestinal disorders	—	—	—	—
Muscle spasms	Musculoskeletal and connective tissue disorders	—	—	—	—
Muscular weakness	Musculoskeletal and connective tissue disorders	—	—	—	—
Diarrhea	Gastrointestinal disorders	—	—	—	—
Visual impairment	Eye disorders	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—
Headache	Nervous system disorders	—	—	—	—
Hypoesthesia	Nervous system disorders	—	—	—	—
Paresthesia	Nervous system disorders	—	—	—	—
Pruritis	Skin and subcutaneous tissue disorders	—	—	—	—
Hypoacusis	Ear and labyrinth disorders	—	—	—	—
Incontinence	Renal and urinary disorders	—	—	—	—
Delayed recovery from anesthesia	Injury, poisoning and procedural complications	—	—	—	—
Seroma	Injury, poisoning and procedural complications	—	—	—	—
Bradycardia	Cardiac disorders	—	—	—	—

Most-reported serious reactions: Dyspnea, Vomiting, Wound infection fungal.

Data from ClinicalTrials.gov NCT03682302 adverse events section.

Sponsor's own description

Primary Objective: To evaluate the pharmacokinetics (PK) of EXPAREL in pediatric subjects aged 6 to less than 17 years undergoing various types of surgeries. Secondary Objective: To evaluate the safety of EXPAREL in pediatric subjects aged 6 to less than 17 years undergoing various types of surgeries.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

A multicenter study to evaluate the pharmacokinetics and safety of liposomal bupivacaine for postsurgical analgesia in pediatric patients aged 6 to less than 17 years (PLAY).
Tirotta CF, de Armendi AJ, Horn ND, Hammer GB, et al · · 2021 · cited 21× · PMID 34534923 · DOI 10.1016/j.jclinane.2021.110503

Verify or expand the search:

Other trials of Exparel

Trials testing the same drug.

NCT06349772 — Zynrelef vs Exparel: The Battle of Postoperative Pain Control After Robotic Sleeve Gastrectomy · EARLY_PHASE1 · recruiting
NCT06574022 — Post-mastectomy Recovery: Comparing Preoperative PECS-II Blocks With Intraoperative Pectoral Blocks · Phase 4 · recruiting
NCT06619340 — EXPAREL IPSA Block in Knee Arthroplasty · Phase 4 · enrolling by invitation
NCT06350981 — Analgesic Requirement for Post-Operative Pain Control in TLIP Interbody Fusion · Phase 2, PHASE3 · enrolling by invitation
NCT06274008 — Exparel vs. ACB With Bupivacaine for ACL Reconstruction · Phase 1 · unknown

Other Pacira Pharmaceuticals, Inc trials

Trials by the same sponsor.

NCT06977568 — A Study to Evaluate an Intra-Articular Injection of ZILRETTA Versus Triamcinolone Acetonide, Immediate Release in Subjec · Phase 2 · terminated
NCT05456490 — Phase 1, Dose Escalation Study to Evaluate of Safety, Pharmacokinetics and Pharmacodynamics of Liposomal Bupivacaine 13. · Phase 1 · completed
NCT05157841 — Phase 3, Sciatic Nerve Block With EXPAREL for Subjects Undergoing Bunionectomy · Phase 3 · completed
NCT05139030 — Phase 3 Adductor Canal Block With EXPAREL in Subjects Undergoing Primary Unilateral Total Knee Arthroplasty · Phase 3 · completed
NCT05495334 — Innovations in Genicular Outcomes Registry · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03682302 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Pacira Pharmaceuticals, Inc
Last refreshed: 6 January 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03682302.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing