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Efficacy and Safety of Oxycodone/Acetaminophen in Postherpetic Neuralgia with Breakthrough Pain Management: A Multicenter Pragmatic Randomized Controlled Trial

Efficacy and Safety of Oxycodone/Acetaminophen in Postherpetic Neuralgia with Breakthrough Pain Management: A Multicenter Pragmatic Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600125505
Enrollment
Unknown
Registered
2026-05-27
Start date
2026-06-01
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postherpetic Neuralgia

Interventions

Experimental Group:Oxycodone/Acetaminophen + pregabalin

Sponsors

Shandong Provincial Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Definite diagnosis of herpes zoster-associated neuralgia confirmed by relevant laboratory tests and examinations. 2.Presence of breakthrough pain (transient pain exacerbation), defined as spontaneous episodes or pain triggered by predictable/unpredictable factors superimposed on persistent background pain, with >3 episodes per day in the past week and Numeric Rating Scale (NRS) score >=4. 3.Age >18 years. 4.Willingness to provide informed consent and ability to complete follow-up.

Exclusion criteria

Exclusion criteria: 1.Bleeding disorders, bronchial asthma, or severe hepatic/renal insufficiency. 2.Known hypersensitivity to opioids, acetaminophen, or pregabalin. 3.Concurrent severe painful conditions (e.g., cancer pain). 4.Pregnancy, lactation, or planned pregnancy. 5.Participation in other investigational drug trials within the preceding 1 month.

Design outcomes

Primary

MeasureTime frame
Pain Relief Rate;Assessment of breakthrough pain;

Secondary

MeasureTime frame
Sleep Quality Assessment;Quality of Life Score (QoL Score);Levels of Pain Mediators and Stress Hormones;Time to First Stable Pain Control;Hospital Anxiety and Depression Scale (HADS) Score;Incidence of Adverse Reactions;Daily Dose;

Countries

China

Contacts

Public ContactSun Tao

Shandong Provincial Hospital

suntaosdph@163.com+86 531 68778328

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 11, 2026