Systemic Diclofenac Sodium Patch for Patients After Lumbar Spine Surgery

Evaluation of the Efficacy of a Systemic Diclofenac Sodium Patch for Postoperative Pain Control in Patients After Lumbar Spine Surgery

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1031250391

Enrollment

100

Registered

2025-09-26

Start date

2025-09-26

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Degenerative lumbar conditions including disc herniation, spinal canal stenosis, spondylolisthesis Lumbar spine

Interventions

In addition to the standard postoperative analgesia protocol that excludes the use of oral NSAIDs, patients in the intervention group will receive a systemic transdermal patch containing diclofenac so

D003994

D000273

Diclofenac sodium transdermal patch

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients aged equal to ore over 18 undergoing posterior lumbar spine surgery for degenerative spine conditions with low back pain.

Exclusion criteria

Exclusion criteria: Patients with long fusion surgery defined equal to or over 3 levels, undergoing anterior-posterior combined procedure including staged surgery, with moderate to severe renal dysfunction, with the history of asthma, or with the history of NSAID allegy.

Design outcomes

Primary

Measure	Time frame
Resting and movement-evoked pain will be assessed using the Numerical Rating Scale (NRS) on postoperative day 0-10 following lumbar spine surgery	—

Secondary

Measure	Time frame
The usage of analgesics, and postoperative mobilization and acquisition of activities of daily living (ADL) using the Barthel Index (BI).	—

Contacts

Public ContactYohei Miyamoto

Showa Medical University

ymiyamoto3@med.showa-u.ac.jp+81-3-3784-8543

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026