Tramadol vs.Tramadol With Paracetamol

Not Applicable

Completed

• Conditions: Lumbar Disc Herniation
• Interventions: Drug: Tramadol; Drug: Paracetamol

• Registration Number: NCT03482492
• Lead Sponsor: Yeditepe University Hospital

Brief Summary

This study focused on to determine postoperative analgesic efficacy of tramadol compared to tramadol with addition of paracetamol after a lumbar disc surgery.

Detailed Description

Background:

Despite developments in treatment of pain, the availability of new drugs or increased knowledge of pain management, postoperative pain control after different surgeries still remains inadequate.

Aims:

This study focused on to determine postoperative analgesic efficacy of tramadol compared to tramadol with addition of paracetamol after a lumbar disc surgery.

Study Design:

In this study we have randomized 60 patients into two treatment groups. In Group Tramadol patients received tramadol, In Group TramadolParacetamol patients received paracetamol 1 gr iv in addition to tramadol 30 minutes before the operation ends and 1 g at 6 hour intervals.

Methods:

Severity of the pain, total tramadol consumption, adverse effects, ramsay sedation scale score, nausea/vomiting scores, patient satisfaction score were recorded in the postoperative period.

Study Timeline

• Study Start: 2014-03-20
• Primary Completion: 2015-01-12
• Study Completion: 2015-04-03
• Status Verified: 2018-03
• Study First Submitted: 2018-03-20
• Study First Submitted QC: 2018-03-27
• Last Update Submitted: 2018-03-27
• Study First Posted: 2018-03-29
• Last Update Posted: 2018-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

American Society of Anesthesiologists (ASA) 1 or 2 status patients with single level lumbar disc herniation.

Exclusion Criteria

Patients who could not use a patient controlled analgesia (PCA) device, known allergies to any of the drugs used in this study,hepatic and renal dysfunction, herniated disc with neurological deficit or intense pain justifying emergency surgery and the patients whose body mass index is ≥30 kg/m2 were excluded from the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tramadol	Tramadol	Group Tramadol patients received tramadol 1 mg kg-1 iv
Tramadol-Paracetamol	Tramadol	Group Tramadol-Paracetamol patients received paracetamol 1 gr iv in addition to tramadol 1 mg kg-1 iv 30 minutes before the end of the operation and after the operation at 6 hour intervals for 24 hours
Tramadol-Paracetamol	Paracetamol	Group Tramadol-Paracetamol patients received paracetamol 1 gr iv in addition to tramadol 1 mg kg-1 iv 30 minutes before the end of the operation and after the operation at 6 hour intervals for 24 hours

Primary Outcome Measures

Name	Time	Method
Severity of pain	2 hours	Self reported pain intensity

Secondary Outcome Measures

Name	Time	Method
Tramadol consumption	2 hours	Total tramadol consumption during time frame