Comparison of Pain Therapeutic Effects After Benign Mastectomy - Tabular View

Tracking Information

First Received Date ^ICMJE

August 21, 2007

Last Updated Date

March 30, 2009

Start Date ^ICMJE

February 2007

Primary Completion Date

December 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Visual analog scale (VAS) rating of pain [ Time Frame: 0-24h after surgeries ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00519246 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

VAS rating of sedation [ Time Frame: 0h to 24h after the end of the operation ] [ Designated as safety issue: Yes ]
Overall VAS rating of satisfaction with analgesia [ Time Frame: 24 h after operation ] [ Designated as safety issue: Yes ]
Incidence of side effects [ Time Frame: From the initiation of analgesia (0 h) to the end of the study (24 h postoperative) ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

VAS rating of sedation [ Time Frame: 0h to 24h after the end of the operation ] [ Designated as safety issue: Yes ]
Overall VAS rating of satisfaction with analgesia [ Time Frame: At the end of the study ] [ Designated as safety issue: Yes ]
Incidence of side effects [ Time Frame: From the initiation of analgesia to the end of the study ] [ Designated as safety issue: Yes ]

Descriptive Information

Brief Title ^ICMJE

Comparison of Pain Therapeutic Effects After Benign Mastectomy

Official Title ^ICMJE

Clinical Comparison of Postoperative Pain Therapeutic Effects After Benign Mastectomy

Brief Summary

With the incremental trend of benign breast tumor, the surgical process of mastectomy was proceeded too much every day, especially in the Maternal Health Care Hospital, but whether the investigators can find another way to relieve the postoperative pain after such an operation is still unknown. The investigators hypothesized that the pain from the relatively small surgery may not be significant compared to different treatments, even if no drug was delivered to them. The investigators are enrolling patients who underwent mastectomy from benign breast tumor, and are observing the analgesic effects of different drugs.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Pain, Postoperative
Mastectomy

Intervention ^ICMJE

Drug: Saline
Drug: Opioid
Drug: NSAID

Study Arms / Comparison Groups

Placebo Comparator: No drug was delivered.
Active Comparator: Butorphanol tartrate 1mg was given intravenously.
Active Comparator: Butorphanol tartrate 2 mg was given intravenously.
Active Comparator: Flurbiprofen Axetil 50 mg was given intravenously.
Active Comparator: Flurbiprofen Axetil 100 mg was given intravenously.
Active Comparator: Tramadol Hydrochloride 10 mg was given intravenously.
Active Comparator: Tramadol Hydrochloride 20 mg was given intravenously.

Publications *

Shen X, Wang F, Xu S, Ma L, Liu Y, Feng S, Wang W, Zhao Q, Li X, Zhao L, Yao X, Qu J, Xie B, Wang H, Yuan H, Cao Y, Sun Y, Wang W, Guo L, Song Z, Wang Z, Guan X. Comparison of the analgesic efficacy of preemptive and preventive tramadol after lumpectomy. Pharmacol Rep. 2008 May-Jun;60(3):415-21.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

2000

Completion Date

December 2007

Primary Completion Date

December 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Chinese
No cardiac and pulmonary diseases
ASA I-II
No alcohol drinking.

Exclusion Criteria:

<19yrs, and >65yrs
History of central active drugs administration
Drug abuse
Hypertension
Diabetes
Any other chronic diseases.

Gender

Female

Ages

18 Years to 64 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

China

Administrative Information

NCT ID ^ICMJE

NCT00519246

Responsible Party

XiaoFeng Shen, Nanjing Maternal and Child Health Hospital

Study ID Numbers ^ICMJE

NMU-2579-4FW, NMCH2007-241

Study Sponsor ^ICMJE

Nanjing Medical University

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

XiaoFeng Shen, MD

Nanjing Medical University

Information Provided By

Nanjing Medical University

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP