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

Laparoscopic Nissen Fundoplication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01558622
• Other study ID #: KVDU 0001 GG
• Status: Unknown status
• Phase: Phase 4
• First received: March 16, 2012
• Last updated: March 22, 2012
• Start date: March 2012

Study information

• Verified date: March 2012
• Source: Kavaklidere Umut Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 72
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Laparoscopic Nissen Fundoplication
• Pain, Postoperative

Intervention

Drug:
• dexketoprofen trometamol
50mg intravenous infusion
• tramadol hydrochloride
100mg intravenous infusion
• pethidine hydrochloride
50mg intravenous infusion
• dexketoprofen trometamol + tramadol hydrochloride
intravenous infusion of 50mg dexketoprofen trometamol + 100mg tramadol hydrochloride
• dexketoprofen trometamol + pethidine hydrochloride
intravenous infusion of 50mg dexketoprofen trometamol + 50mg pethidine hydrochloride
• vitamin c
500mg intravenous infusion

Locations

Country	Name	City	State
Turkey	Kavaklidere Umut Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Kavaklidere Umut Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Allergic reactions to NSAIDs or opioid analgesics, body mass index exceeding 35		postoperative 2 hours