Postoperative Analgesia in Laminectomy

Postoperative Pain Clinical Trial

— (PAL)  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02255955
• Other study ID #: Pstoperative pain
• Status: Not yet recruiting
• Phase: Phase 4
• First received: September 27, 2014
• Last updated: December 25, 2014
• Start date: October 2014
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: Diskapi Yildirim Beyazit Education and Research Hospital
• Contact: Reyhan Polat, MD
• Phone: +905326734310
• Email: reyhanp9[@]gmail.com
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 75
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Laminectomy Pain
• Postoperative Pain

Intervention

Drug:
• 550 mg naproxen sodium and 30mg codeine
Postoperative contramal consumption, pain intensity, side effects
• 300 mg paracetamol and 30 mg codeine
Postoperative contramal consumption, pain intensity, side effects
• placebo tablet
Postoperative contramal consumption, pain intensity, side effects

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Diskapi Yildirim Beyazit Education and Research Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Contramal consumption	To assess contramal consumption	Postoperative 24 hour	No
Secondary	Side effects	nausea and vomiting	postoperative 24 hour	No
Secondary	Pain intensity	To assess postoperative pain intensity by visual analog scale	postoperative 24 hour	No