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

Study Overview
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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.

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

Conditions
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Laparoscopic Nissen Fundoplication

Intervention / Treatment
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* Drug: dexketoprofen trometamol
* Drug: tramadol hydrochloride
* Drug: pethidine hydrochloride
* Drug: dexketoprofen trometamol + tramadol hydrochloride
* Drug: dexketoprofen trometamol + pethidine hydrochloride
* Drug: vitamin c


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: dexketoprofen trometamol<br>Dexketoprofen trometamol is a water-soluble salt of the dextrorotatory enantiomer of the nonsteroidal anti-inflammatory drug (NSAID) ketoprofen. | Drug: dexketoprofen trometamol<br>* 50mg intravenous infusion<br>|
| Placebo Comparator: tramadol hydrochloride<br>Tramadol Hydrochloride is a well-known centrally acting opioid pain killer. | Drug: tramadol hydrochloride<br>* 100mg intravenous infusion<br>|
| Placebo Comparator: pethidine hydrochloride<br>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<br>* 50mg intravenous infusion<br>|
| Placebo Comparator: dexketoprofen trometamol + tramadol hydrochloride<br> | Drug: dexketoprofen trometamol + tramadol hydrochloride<br>* intravenous infusion of 50mg dexketoprofen trometamol + 100mg tramadol hydrochloride<br>|
| Placebo Comparator: dexketoprofen trometamol + pethidine hydrochloride<br> | Drug: dexketoprofen trometamol + pethidine hydrochloride<br>* intravenous infusion of 50mg dexketoprofen trometamol + 50mg pethidine hydrochloride<br>|
| Placebo Comparator: vitamin c<br> | Drug: vitamin c<br>* 500mg intravenous infusion<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postoperative analgesia, dexketoprofen trometamol, tramadol hydrochloride, pethidine, laparoscopic Nissen fundoplication