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

Phase 4

• Conditions: Laparoscopic Nissen Fundoplication
• Interventions: Drug: dexketoprofen trometamol; Drug: pethidine hydrochloride; Drug: dexketoprofen trometamol + tramadol hydrochloride; Drug: dexketoprofen trometamol + pethidine hydrochloride; Drug: vitamin c; Drug: tramadol hydrochloride

• Registration Number: NCT01558622
• Lead Sponsor: Kavaklıdere Umut Hospital

Brief Summary

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

Not available

Study Timeline

• Status Verified: 2012-03
• Study Start: 2012-03
• Study First Submitted: 2012-03-16
• Study First Submitted QC: 2012-03-19
• Study First Posted: 2012-03-20
• Last Update Submitted: 2012-03-22
• Last Update Posted: 2012-03-23
• Primary Completion: 2012-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 72

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
dexketoprofen trometamol	dexketoprofen trometamol	Dexketoprofen trometamol is a water-soluble salt of the dextrorotatory enantiomer of the nonsteroidal anti-inflammatory drug (NSAID) ketoprofen.
pethidine hydrochloride	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.
dexketoprofen trometamol + tramadol hydrochloride	dexketoprofen trometamol + tramadol hydrochloride	-
dexketoprofen trometamol + pethidine hydrochloride	dexketoprofen trometamol + pethidine hydrochloride	-
vitamin c	vitamin c	-
tramadol hydrochloride	tramadol hydrochloride	Tramadol Hydrochloride is a well-known centrally acting opioid pain killer.

Primary Outcome Measures

Name	Time	Method
Allergic reactions to NSAIDs or opioid analgesics, body mass index exceeding 35	postoperative 2 hours

Trial Locations

Locations (1)

Kavaklidere Umut Hospital; 🇹🇷 Ankara, Turkey