Intraoperative Use of Dexketoprofen Trometamol, Pethidine Hcl, Tramadol Hcl and Their Combinations for Postoperative Pain Management in Laparoscopic Nissen Fundoplication

March 22, 2012 updated by: GOKHAN GOKMEN, Kavaklıdere Umut Hospital

Intraoperative Use of Dexketoprofen Trometamol, Tramadol Hcl, Pethidine Hcl and Their Combinations for Postoperative Pain Management in Laparoscopic Nissen Fundoplication

The purpose of this study is to evaluate the analgesic effects of dexketoprofen trometamol, tramadol hydrochloride, pethidine hydrochloride and their combinations in laparoscopic Nissen fundoplication.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

72

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.

Study Locations

  • Turkey
      • Ankara, Turkey, 06660
        • Kavaklidere Umut Hospital

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

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18-60 years old ASA I-II patients
  • Clinical diagnosis of gastroesophageal reflux patients

Exclusion Criteria:

  • Allergic reactions to NSAIDs or opioid analgesics
  • Body mass index exceeding 35
  • Pregnancy

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: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: dexketoprofen trometamol
Dexketoprofen trometamol is a water-soluble salt of the dextrorotatory enantiomer of the nonsteroidal anti-inflammatory drug (NSAID) ketoprofen.
Drug: dexketoprofen trometamol
50mg intravenous infusion
PLACEBO_COMPARATOR: tramadol hydrochloride
Tramadol Hydrochloride is a well-known centrally acting opioid pain killer.
Drug: tramadol hydrochloride
100mg intravenous infusion
PLACEBO_COMPARATOR: pethidine hydrochloride
Pethidine is a synthetic opioid analgesic which produces a pattern of effects similar to morphine the standard against which opioid analgesics are compared.
Drug: pethidine hydrochloride
50mg intravenous infusion
PLACEBO_COMPARATOR: dexketoprofen trometamol + tramadol hydrochloride
Drug: dexketoprofen trometamol + tramadol hydrochloride
intravenous infusion of 50mg dexketoprofen trometamol + 100mg tramadol hydrochloride
PLACEBO_COMPARATOR: dexketoprofen trometamol + pethidine hydrochloride
Drug: dexketoprofen trometamol + pethidine hydrochloride
intravenous infusion of 50mg dexketoprofen trometamol + 50mg pethidine hydrochloride
PLACEBO_COMPARATOR: vitamin c
Drug: vitamin c
500mg intravenous infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Allergic reactions to NSAIDs or opioid analgesics, body mass index exceeding 35
Time Frame: postoperative 2 hours
postoperative 2 hours

Collaborators and Investigators

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

Sponsor

Kavaklıdere Umut Hospital

Investigators

  • Principal Investigator: GOKHAN GOKMEN, Specialist

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

March 1, 2012

Primary Completion (ANTICIPATED)

May 1, 2012

Study Registration Dates

First Submitted

March 16, 2012

First Submitted That Met QC Criteria

March 19, 2012

First Posted (ESTIMATE)

March 20, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

March 23, 2012

Last Update Submitted That Met QC Criteria

March 22, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KVDU 0001 GG

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.

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