Continuous Infusion of Dexamethasone Plus Tramadol Adjunct to Morphine PCA After Abdominal Hysterectomy (DTMPCA)

April 17, 2008 updated by: Nanjing Medical University

Intravenous Continuous Infusion of Dexamethasone Plus Tramadol Combined With Standard Morphine Patient-Controlled Analgesia After Total Abdominal Hysterectomy

Dexamethasone has been recognized as an antiemetic agent after surgeries, and the combination of dexamethasone and tramadol remained stable in solution up to 5 days. In addition, i.v. basal infusion of tramadol is a certified technique in postoperative pain management. We purposed that combined administration of dexamethasone and tramadol adjunct to i.v. morphine is an effective way in treating postoperative pain.

Study Overview

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Jiangsu
      • Nanjing, Jiangsu, China, 210004
        • Nanjing Maternal and Child Care Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 62 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. ASA physical status I-II
  2. Chinese
  3. 19-64yr
  4. Uterus myoma

Exclusion Criteria:

  1. Allergy to opioids, a history of the use of centrally-acting drugs of any sort, chronic pain and psychiatric diseases records.
  2. Participants younger than 18yr,older than 65yr or pregnancy was eliminated.
  3. Due to the significant changes in vital signs might affect cognition of pain and that of sensation, over 20% variation of these records from the baselines or below 92% of SpO2 under 20-40% nasal tube oxygen at any time should be excluded from the study.
  4. Those who were not willing to or could not finish the whole study at any time.
  5. Any patient who exhibited a combative or incoherent state of PCA analgesia would be excluded from the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 1
Saline with same volume added to tramadol infusion combined with morphine PCA.
Saline, in same volume of 2mL
Active Comparator: 2
Dexamethasone 10mg in 2mL added to tramadol infusion adjunct to morphine PCA.
Dexamethasone, 10mg, continuously infused up to 48h after surgeries.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Visual analog scale (VAS) of pain
Time Frame: 0-48h after surgeries
0-48h after surgeries

Secondary Outcome Measures

Outcome Measure
Time Frame
First requirement of morphine; Total morphine consumption; VAS sedation; VAS satisfaction; Side effects; Overall conditions of patients;
Time Frame: 0-48h after surgeries
0-48h after surgeries

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

November 26, 2007

First Submitted That Met QC Criteria

November 26, 2007

First Posted (Estimate)

November 28, 2007

Study Record Updates

Last Update Posted (Estimate)

April 21, 2008

Last Update Submitted That Met QC Criteria

April 17, 2008

Last Verified

April 1, 2008

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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