Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Tramadol vs.Tramadol With Paracetamol

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03482492
Recruitment Status : Completed
First Posted : March 29, 2018
Last Update Posted : March 29, 2018
Sponsor:
Information provided by (Responsible Party):
Neslihan Uztüre, 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.

Condition or disease Intervention/treatment Phase
Lumbar Disc Herniation Drug: Tramadol Drug: Paracetamol Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Comparison of Tramadol vs. Tramadol With Paracetamol for Efficacy of Postoperative Pain Management in Lumbar Discectomy: A Randomised Controlled Trial
Actual Study Start Date : March 20, 2014
Actual Primary Completion Date : January 12, 2015
Actual Study Completion Date : April 3, 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Tramadol

Arm Intervention/treatment
Active Comparator: Tramadol
Group Tramadol patients received tramadol 1 mg kg-1 iv
Drug: Tramadol
Tramadol iv

Active Comparator: Tramadol-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
Drug: Tramadol
Tramadol iv

Drug: Paracetamol
Paracetamol iv




Primary Outcome Measures :
  1. Severity of pain [ Time Frame: 2 hours ]
    Self reported pain intensity


Secondary Outcome Measures :
  1. Tramadol consumption [ Time Frame: 2 hours ]
    Total tramadol consumption during time frame



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03482492


Sponsors and Collaborators
Yeditepe University Hospital
Investigators
Layout table for investigator information
Principal Investigator: Neslihan Uztüre, MD Yeditepe University

Publications:

Layout table for additonal information
Responsible Party: Neslihan Uztüre, Principal Investigator, Yeditepe University Hospital
ClinicalTrials.gov Identifier: NCT03482492     History of Changes
Other Study ID Numbers: 11.03.2014-397
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Neslihan Uztüre, Yeditepe University Hospital:
Acetaminophen
Tramadol
Discogenic pain
Lumbar Discectomy
Additional relevant MeSH terms:
Layout table for MeSH terms
Tramadol
Hernia
Pathological Conditions, Anatomical
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Analgesics, Opioid
Narcotics
Central Nervous System Depressants