Postoperative Analgesia in Laminectomy ((PAL))

December 25, 2014 updated by: Reyhan Polat, Diskapi Yildirim Beyazit Education and Research Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

75

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 85 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 550 mg naproxen sodium and 30mg codeine
Preoperatively patients received oral naproxen sodium codeine, postop contramal infused by PCA, and postoperative contramal consumption, side effects pain intensity measured by VAS.
Drug: 550 mg naproxen sodium and 30mg codeine
Postoperative contramal consumption, pain intensity, side effects
Other Names:
  • Apranax plus
Active Comparator: 300 mg paracetamol and 30 mg codeine
Preoperatively patients received oral paracetamol codeine, postop contramal infused by PCA, and postoperative contramal consumption, side effects pain intensity measured by VAS.
Drug: 300 mg paracetamol and 30 mg codeine
Postoperative contramal consumption, pain intensity, side effects
Other Names:
  • geralgine K
Placebo Comparator: Placebo
Preoperatively patients received oral placebo tablet, postop contramal infused by PCA, and postoperative contramal consumption, side effects pain intensity measured by VAS.
Drug: placebo tablet
Postoperative contramal consumption, pain intensity, side effects

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Contramal consumption
Time Frame: Postoperative 24 hour
To assess contramal consumption
Postoperative 24 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Side effects
Time Frame: postoperative 24 hour
nausea and vomiting
postoperative 24 hour
Pain intensity
Time Frame: postoperative 24 hour
To assess postoperative pain intensity by visual analog scale
postoperative 24 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Diskapi Yildirim Beyazit Education and Research Hospital

Investigators

  • Principal Investigator: Reyhan Polat, MD, Ministry of Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Anticipated)

December 1, 2014

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

September 27, 2014

First Submitted That Met QC Criteria

October 2, 2014

First Posted (Estimate)

October 3, 2014

Study Record Updates

Last Update Posted (Estimate)

December 30, 2014

Last Update Submitted That Met QC Criteria

December 25, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pstoperative pain

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Postoperative Pain

Clinical Trials on 550 mg naproxen sodium and 30mg codeine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ireland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe