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Postoperative Analgesia in Laminectomy

The Effect of Naproxen Sodium + Codeine, and Paracetamol+ Codeine on Postoperative Laminectomy Pain

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02255955
Acronym
(PAL)
Enrollment
75
Registered
2014-10-03
Start date
2014-10-31
Completion date
2014-12-31
Last updated
2014-12-30

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

Conditions

Postoperative Laminectomy Pain, Postoperative Pain

Keywords

naproxen sodium codeine, paracetamol codeine, disk surgery

Brief summary

Compare the analgesic effects of naproxen sodium codeine, paracetamol codeine and placebo on postoperative pain and tramadol (Contramal) consumption during the first 24 hour after a lumbar disk surgery.

Detailed description

Compare the analgesic effects of naproxen sodium codeine paracetamol codeine and placebo on postoperative pain intensity measured by the visual analogue scale, and evaluated tramadol consumption and related side effects.

Interventions

DRUG550 mg naproxen sodium and 30mg codeine

Postoperative contramal consumption, pain intensity, side effects

DRUG300 mg paracetamol and 30 mg codeine

Postoperative contramal consumption, pain intensity, side effects

DRUGplacebo tablet

Postoperative contramal consumption, pain intensity, side effects

Sponsors

Diskapi Yildirim Beyazit Education and Research Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
16 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

* American Society of Anesthesiologists (ASA) 1 or 2 status patients scheduled for an elective lumbar disc surgery

Exclusion criteria

* were known allergies to any of the drugs used in this study * peptic ulcer disease * hepatic and renal dysfunction, * emergency surgery * inability to provide informed consent

Design outcomes

Primary

MeasureTime frameDescription
Contramal consumptionPostoperative 24 hourTo assess contramal consumption

Secondary

MeasureTime frameDescription
Side effectspostoperative 24 hournausea and vomiting
Pain intensitypostoperative 24 hourTo assess postoperative pain intensity by visual analog scale

Contacts

Primary ContactReyhan Polat, MD
reyhanp9@gmail.com+905326734310

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026