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Comparison of Postoperative Analgesic Efficacy of Intravenous Dexketoprofen Trometamol With Tenoxicam

Primary Purpose

Postoperative Pain

Status

Unknown status

Phase

Phase 4

Locations

Turkey

Study Type

Interventional

Intervention

dexketoprofen trometamol

tenoxicam

serum physiologic

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring dexketoprofen trometamol, tenoxicam, postoperative pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

ASA 1-2
between 18-65 age
elective lumbar disc surgery

Exclusion Criteria:

history of gastrointestinal bleeding
peptic ulcer disease
bleeding disorders
history of allergic reactions to NSAİDs
chronic pain syndrome

Sites / Locations

Erciyes Universty HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

dexketoprofen trometamol

tenoxicam

serum physiologic

Arm Description

before end of the surgery via intravenous administration 50 mg dexketoprofen trometamol in 0.9 % NaCl 100 cc

before the end of the surgery via administration intravenous 20 mg tenoxicam in 0.9% NaCl in 100 cc

before end of the surgery via administration intravenous 0.9 % NaCl 100 cc

Outcomes

Primary Outcome Measures

analgesic consumption

morphine consumption (patient control analgesia procedure) was recorded

Secondary Outcome Measures

visual analog scale

visual analog scale on rest and movement was recorded

Full Information

NCT ID

NCT02160236

First Posted

June 8, 2014

Last Updated

November 7, 2014

Sponsor

TC Erciyes University

1. Study Identification

Unique Protocol Identification Number

NCT02160236

Brief Title

Comparison of Postoperative Analgesic Efficacy of Intravenous Dexketoprofen Trometamol With Tenoxicam

Official Title

Comparison of Postoperative Analgesic Efficacy of Intravenous Dexketoprofen Trometamol With Tenoxicam in Lumbar Disc Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

November 2014

Overall Recruitment Status

Unknown status

Study Start Date

November 2014 (undefined)

Primary Completion Date

February 2015 (Anticipated)

Study Completion Date

February 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

TC Erciyes University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

In this study the investigators aimed to compare of postoperative analgesic effects of intravenous dexketoprofen trometamol and tenoxicam in lumbar disc surgery.

Detailed Description

Lumbar disc surgery is associated with moderate to severe back and radicular pain postoperatively which has unfavorable effects on patients recovery and procedures outcome. Dexketoprofen has been reported to be one of the NSAİDs that can provide good results when compared with narcotics in many painful conditions and especially in the treatment of the moderate to severe postoperative pain that may develop after lumbal disc surgery. Tenoxicam is a thienothiazine derivative of the oxicam class of NSAİDs. There are some studies in which NSAİDs have been used to together with opioids for postoperative analgesia showing that they decrease opioid consumption and side effects

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Pain

Keywords

dexketoprofen trometamol, tenoxicam, postoperative pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

dexketoprofen trometamol

Arm Type

Active Comparator

Arm Description

before end of the surgery via intravenous administration 50 mg dexketoprofen trometamol in 0.9 % NaCl 100 cc

Arm Title

tenoxicam

Arm Type

Active Comparator

Arm Description

before the end of the surgery via administration intravenous 20 mg tenoxicam in 0.9% NaCl in 100 cc

Arm Title

serum physiologic

Arm Type

Placebo Comparator

Arm Description

before end of the surgery via administration intravenous 0.9 % NaCl 100 cc

Intervention Type

Drug

Intervention Name(s)

dexketoprofen trometamol

Other Intervention Name(s)

arveles

Intervention Description

before end of the surgery via intravenous administration 50 mg dexketoprofen trometamol in 0.9 % NaCl 100 cc

Intervention Type

Drug

Intervention Name(s)

tenoxicam

Other Intervention Name(s)

oksamen

Intervention Description

before the end of the surgery via administration intravenous 20 mg tenoxicam in 0.9% NaCl in 100 cc

Intervention Type

Drug

Intervention Name(s)

serum physiologic

Intervention Description

before end of the surgery via administration intravenous 0.9 % NaCl 100 cc

Primary Outcome Measure Information:

Title

analgesic consumption

Description

morphine consumption (patient control analgesia procedure) was recorded

Time Frame

postoperative 1 day

Secondary Outcome Measure Information:

Title

visual analog scale

Description

visual analog scale on rest and movement was recorded

Time Frame

postoperative 1 day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: ASA 1-2 between 18-65 age elective lumbar disc surgery Exclusion Criteria: history of gastrointestinal bleeding peptic ulcer disease bleeding disorders history of allergic reactions to NSAİDs chronic pain syndrome

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Nazife Küçük, resident

Phone

+905072317446

nzfkucuk@hotmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Halit Madenoğlu, prof

Phone

+903522076666

Ext

24032

halitm@erciyes.edu.tr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

nazife küçük, resident

Organizational Affiliation

TC Erciyes University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Erciyes Universty Hospital

City

Kayseri

ZIP/Postal Code

38039

Country

Turkey

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

nazife küçük, resident

Phone

+905072317446

nzfkucuk@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

Comparison of Postoperative Analgesic Efficacy of Intravenous Dexketoprofen Trometamol With Tenoxicam

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