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

NCT ID: NCT01558622

Last Updated: 2012-03-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Laparoscopic Nissen Fundoplication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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dexketoprofen trometamol

Dexketoprofen trometamol is a water-soluble salt of the dextrorotatory enantiomer of the nonsteroidal anti-inflammatory drug (NSAID) ketoprofen.

Group Type PLACEBO_COMPARATOR

dexketoprofen trometamol

Intervention Type DRUG

50mg intravenous infusion

tramadol hydrochloride

Tramadol Hydrochloride is a well-known centrally acting opioid pain killer.

Group Type PLACEBO_COMPARATOR

tramadol hydrochloride

Intervention Type DRUG

100mg intravenous infusion

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.

Group Type PLACEBO_COMPARATOR

pethidine hydrochloride

Intervention Type DRUG

50mg intravenous infusion

dexketoprofen trometamol + tramadol hydrochloride

Group Type PLACEBO_COMPARATOR

dexketoprofen trometamol + tramadol hydrochloride

Intervention Type DRUG

intravenous infusion of 50mg dexketoprofen trometamol + 100mg tramadol hydrochloride

dexketoprofen trometamol + pethidine hydrochloride

Group Type PLACEBO_COMPARATOR

dexketoprofen trometamol + pethidine hydrochloride

Intervention Type DRUG

intravenous infusion of 50mg dexketoprofen trometamol + 50mg pethidine hydrochloride

vitamin c

Group Type PLACEBO_COMPARATOR

vitamin c

Intervention Type DRUG

500mg intravenous infusion

Interventions

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dexketoprofen trometamol

50mg intravenous infusion

Intervention Type DRUG

tramadol hydrochloride

100mg intravenous infusion

Intervention Type DRUG

pethidine hydrochloride

50mg intravenous infusion

Intervention Type DRUG

dexketoprofen trometamol + tramadol hydrochloride

intravenous infusion of 50mg dexketoprofen trometamol + 100mg tramadol hydrochloride

Intervention Type DRUG

dexketoprofen trometamol + pethidine hydrochloride

intravenous infusion of 50mg dexketoprofen trometamol + 50mg pethidine hydrochloride

Intervention Type DRUG

vitamin c

500mg intravenous infusion

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kavaklıdere Umut Hospital

OTHER

Sponsor Role lead

Responsible Party

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GOKHAN GOKMEN

Anesthesiologist, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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GOKHAN GOKMEN, Specialist

Role: PRINCIPAL_INVESTIGATOR

Locations

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Kavaklidere Umut Hospital

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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KVDU 0001 GG

Identifier Type: -

Identifier Source: org_study_id

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