Comparison of Butorphanol and Tramadol Associated Patient-Controlled Analgesia (PCA) After Hysterectomy (BATPCAH)

March 30, 2009 updated by: Nanjing Medical University

Butorphanol and Tramadol for Morphine PCA Pain Management After Total Hysterectomy

Intravenous patient-controlled analgesia (PCA) is a popular technique for postoperative pain management. Although several drugs are recognized as effective therapeutic options, optimal selection of drugs in hysterectomy patients underwent different anesthesia treatments remains unknown explicitly. The investigators hypothesized that butorphanol and tramadol can produce different analgesic effects with intravenous PCA after abdominal hysterectomy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

841

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

  • China
    • 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

15 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • ASA physical status I-II
  • Chinese
  • 19-64yr
  • Uterus myoma

Exclusion Criteria:

  • Allergy to opioids, a history of the use of centrally-acting drugs of any sort, chronic pain and psychiatric diseases records.
  • Participants younger than 18yr，older than 65yr or pregnancy was eliminated.
  • 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.
  • Those who were not willing to or could not finish the whole study at any time.
  • Any patient who exhibited a combative or incoherent state of PCA analgesia would be excluded from the study.
  • Allergy to local anesthetics.
  • Failed to perform the epidural catheterization.
  • Those who demonstrated significant nerve-associated side effects from the insertion of the epidural needle.

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
Experimental: 1
Butorphanol basal infusion adjunct to morphine PCA
Drug: Butorphanol tartrate
Butorphanol was delivered at a continuous infusion manner adjunct to morphine PCA pump
Other Names:
  • BT
Experimental: 2
Saline infusion adjunct to morphine PCA
Drug: Saline
Saline infusion adjunct to morphine PCA pump
Other Names:
  • SA
Drug: Saline
Preemptive saline as a control group to tramadol one
Other Names:
  • PS
Experimental: 3
Premedication of Tramadol
Drug: Tramadol Hydrochloride
100mg tramadol was used preemptively to morphine PCA pump
Other Names:
  • TH
Experimental: 4
Preemptive saline for morphine PCA
Drug: Saline
Saline infusion adjunct to morphine PCA pump
Other Names:
  • SA
Drug: Saline
Preemptive saline as a control group to tramadol one
Other Names:
  • PS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
VAS pain scoring;
Time Frame: 5 months
5 months

Secondary Outcome Measures

Outcome Measure
Time Frame
VAS sedation scoring; VAS happiness scoring; Adverse effects; Patient's overall conditions.
Time Frame: 5 months
5 months

Collaborators and Investigators

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

Sponsor

Nanjing Medical University

Collaborators

HRSA/Maternal and Child Health Bureau

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2007

Primary Completion (Actual)

May 1, 2007

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

August 1, 2007

First Submitted That Met QC Criteria

August 1, 2007

First Posted (Estimate)

August 2, 2007

Study Record Updates

Last Update Posted (Estimate)

March 31, 2009

Last Update Submitted That Met QC Criteria

March 30, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NMU-2579-3FW
  • NMU2007092

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.

Clinical Trials on Postoperative Pain

Clinical Trials on Butorphanol tartrate

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Oman

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe