Tummy Tuck Trials: Abdominoplasty as a Model in Acute Pain Research

1.Introduction

Abdominoplasty—also known as a tummy tuck—is widely used in clinical research as a soft‑tissue acute postoperative pain model. Since its formal introduction in 2014, this surgical procedure has become a regulatory gold standard for evaluating non‑bone pain treatments, complementing traditional models like bunionectomy or molar extraction [1].

2.Abdominoplasty as a Clinical Model

Researchers introduced abdominoplasty as a reproducible and fast‑enrolling soft‑tissue model to meet FDA and EMA requirements for analgesic approval in both hard‑ and soft‑tissue pain settings. It offers a homogeneous patient population, **predictablepredictable pain trajectories, and standardizable surgical procedures, making it ideal for controlled analgesic trials [1].

3.Key Trial Designs & Pain Timelines

Abdominoplasty trials often involve mini‑ or full abdominoplasty, with mini variants typically resulting in shorter operative time and a pain peak around 48 hours, while full procedures can produce a longer pain course reaching 72 hours. This alignment matters because protocols commonly use SPID (sum of pain intensity differences) over 24 or 48 hours as primary endpoints, along with NPRS (numeric pain rating scale) and rescue‑medication consumption metrics [1].

4.Major Analgesic Trials in Tummy Tuck Patients

VX‑548 (Suzetrigine, NaV1.8 inhibitor)

In a large randomized Phase III Trial (~303 abdominoplasty subjects), high‑dose suzetrigine reduced SPID48 significantly versus placebo (difference ≈ 37.8; P ≈ 0.0097). Lower doses were not superior to placebo. Common side effects included nausea, headache, dizziness, and constipation [2][3][4][6]. Another source highlighted that high dose (100 mg loading + 50 mg every 12 h) lowered pain vs. placebo but showed no advantage over hydrocodone‑acetaminophen control [0search0] [0search12].

The FDA granted Breakthrough Therapy designation and plans two pivotal Phase 3 studies in bunionectomy and abdominoplasty to support registration [0search11]. Suzetrigine is now FDA‑approved as the first non‑opioid class in acute pain in over 20 years [0search10].

Oliceridine (Olinvyk, µ‑biased opioid)

Trevena, Inc. conducted a multi-center Phase II trial in abdominoplasty patients (~200 individuals). Two doses of oliceridine achieved the primary endpoint versus placebo (P = 0.0001 and 0.0005) based on NPRS over 24 h, and were comparable to morphine. Rescue regimens included ibuprofen and oxycodone as needed [0search3].

Meloxicam IV (Anjeso) & Other Local Implants

The first fully abdominoplasty-based pivotal Phase III was conducted by Baudax Bio in 2016. In 219 patients, their IV meloxicam formulation demonstrated significant improvement in pain outcomes, including SPID24, versus placebo, meeting primary and key secondary endpoints [0search3].

HSK21542 (Peripherally-restricted κ-opioid agonist)

Two Phase III trials in abdominal surgery (including abdominoplasty) revealed statistically superior SPID0‑24h outcomes versus placebo in both HSK21542 arms. One study also confirmed non‑inferiority to tramadol. Gastrointestinal side effects were fewer than tramadol; grade ≥3 adverse events occurred in ≤6% of treated patients [0search9].

5.Enrollment, Success Rates & Safety Profiles

Review of at least 13 industry‑sponsored abdominoplasty trials since 2014 shows ~9 abdominoplasty‑only studies with public data, of which ~7 achieved statistical significance versus placebo. Failures typically stemmed from underpowered Phase II trials with small sample sizes (~6–11 subjects per arm) [1].

Common placebo-arm adverse events across trials included nausea (up to ~30‑40%), headache, dizziness, and constipation; no serious surgical complications were reported thanks to standard surgical technique and consistent protocols [1][0search3].

6.Future Directions & Emerging Practices

Current research emphasizes multimodal analgesia protocols combining regional nerve blocks (TAP, ESP, QL blocks), local anesthetic implants, NSAIDs, and minimal opioid rescue. Efforts to expand the typical trial population (e.g. including more male participants, patients with higher BMI, and longer follow‑up for chronic pain development) are recommended for broader generalizability [1].

7.Conclusion

Tummy tuck (abdominoplasty) trials have emerged as a robust, well-validated soft‑tissue pain model essential for evaluating novel analgesics. Key agents including suzetrigine, oliceridine, meloxicam IV, and HSK21542 have demonstrated efficacy and acceptable safety profiles in this surgical setting. Continued innovation in techniques and broader population inclusion will strengthen the relevance of upcoming studies.

References (with URLs)

1. Singla N, Rogier T. Abdominoplasty as an acute postoperative pain model: insights from 8 years of clinical trials (narrative review, 2025) [https://www.researchgate.net/publication/362617796_Abdominoplasty_as_an_acute_postoperative_pain_model_insights_from_8_years_of_clinical_trials]
2. “Selective Inhibition of Na V1.8 with VX‑548 for Acute Pain,” NEJM Phase III report (2023/2024) [https://www.nejm.org/doi/full/10.1056/NEJMoa2209870]
3. PubMed summary: VX‑548 oral loading dose 100 mg then 50 mg q12h significantly decreased pain vs placebo in abdominoplasty and bunionectomy; well tolerated [https://pubmed.ncbi.nlm.nih.gov/39552600/]
4. ResearchGate/NEJM Phase III details: SPID48 difference ≈ 37.8, P ≈ 0.0097 high‑dose vs placebo [https://www.researchgate.net/publication/372883923_Selective_Inhibition_of_NaV18_with_VX-548_for_Acute_Pain]
5. ClinicalTrials.gov entry NCT05034952: VX‑548 abdominoplasty trial registration [https://clinicaltrials.gov/study/NCT05034952]
6. FDA briefing minutes: plans for VX‑548 pivotal studies in bunionectomy and abdominoplasty [https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/219209Orig1s000AdminCorres.pdf]
7. NeurologyLive: FDA approves suzetrigine for acute pain; significant pain reduction in abdominoplasty and bunionectomy trials [https://www.neurologylive.com/view/fda-approves-vertex-pharmaceuticals-suzetrigine-acute-pain-management]
8. PubMed/PMC: oliceridine Phase II abdominoplasty trial outcomes and methodology [https://pmc.ncbi.nlm.nih.gov/articles/PMC9833108/]
9. Nature: HSK21542 Phase 3 efficacy & safety in abdominal surgery including abdominoplasty [https://www.nature.com/articles/s41467-025-60013-y]