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Comparison of Pain Therapeutic Effects After Benign Mastectomy (COPTEAM)

Primary Purpose

Pain, Postoperative, Mastectomy

Status

Completed

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Saline

Opioid

NSAID

Opioid

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring Breast Neoplasms, Non-Steroidal Anti-Inflammatory Agents, Analgesia

Eligibility Criteria

18 Years - 64 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Nanjing Maternal and Child Care Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Placebo Comparator

Active Comparator

Arm Label

III

VII

Arm Description

No drug was delivered.

Butorphanol tartrate 1mg was given intravenously.

Butorphanol tartrate 2 mg was given intravenously.

Flurbiprofen Axetil 50 mg was given intravenously.

Flurbiprofen Axetil 100 mg was given intravenously.

Tramadol Hydrochloride 10 mg was given intravenously.

Tramadol Hydrochloride 20 mg was given intravenously.

Outcomes

Primary Outcome Measures

Visual analog scale (VAS) rating of pain

Secondary Outcome Measures

VAS rating of sedation

Overall VAS rating of satisfaction with analgesia

Incidence of side effects

Full Information

NCT ID

NCT00519246

First Posted

August 21, 2007

Last Updated

March 30, 2009

Sponsor

Nanjing Medical University

1. Study Identification

Unique Protocol Identification Number

NCT00519246

Brief Title

Comparison of Pain Therapeutic Effects After Benign Mastectomy

Acronym

COPTEAM

Official Title

Clinical Comparison of Postoperative Pain Therapeutic Effects After Benign Mastectomy

Study Type

Interventional

2. Study Status

Record Verification Date

March 2009

Overall Recruitment Status

Completed

Study Start Date

February 2007 (undefined)

Primary Completion Date

December 2007 (Actual)

Study Completion Date

December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Nanjing Medical University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain, Postoperative, Mastectomy

Keywords

Breast Neoplasms, Non-Steroidal Anti-Inflammatory Agents, Analgesia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

2000 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Placebo Comparator

Arm Description

No drug was delivered.

Arm Title

Arm Type

Active Comparator

Arm Description

Butorphanol tartrate 1mg was given intravenously.

Arm Title

III

Arm Type

Active Comparator

Arm Description

Butorphanol tartrate 2 mg was given intravenously.

Arm Title

Arm Type

Active Comparator

Arm Description

Flurbiprofen Axetil 50 mg was given intravenously.

Arm Title

Arm Type

Active Comparator

Arm Description

Flurbiprofen Axetil 100 mg was given intravenously.

Arm Title

Arm Type

Active Comparator

Arm Description

Tramadol Hydrochloride 10 mg was given intravenously.

Arm Title

VII

Arm Type

Active Comparator

Arm Description

Tramadol Hydrochloride 20 mg was given intravenously.

Intervention Type

Drug

Intervention Name(s)

Saline

Other Intervention Name(s)

Physiological solution

Intervention Description

Saline 5 ml administrated intravenously

Intervention Type

Drug

Intervention Name(s)

Opioid

Other Intervention Name(s)

NuoYang

Intervention Description

Butorphanol tartrate 1 mg i.v.

Intervention Type

Drug

Intervention Name(s)

Opioid

Other Intervention Name(s)

NuoYang

Intervention Description

Butorphanol Tartrate 2 mg i.v.

Intervention Type

Drug

Intervention Name(s)

NSAID

Other Intervention Name(s)

CaiFen

Intervention Description

Flurbiprofen Axetil 50 mg i.v.

Intervention Type

Drug

Intervention Name(s)

NSAID

Other Intervention Name(s)

CaiFen

Intervention Description

Flurbiprofen Axetil 100 mg i.v.

Intervention Type

Drug

Intervention Name(s)

Opioid

Other Intervention Name(s)

Trama

Intervention Description

Tramadol Hydrochloride 10 mg i.v.

Intervention Type

Drug

Intervention Name(s)

Opioid

Other Intervention Name(s)

Trama

Intervention Description

Tramadol Hydrochloride 20 mg i.v.

Primary Outcome Measure Information:

Title

Visual analog scale (VAS) rating of pain

Time Frame

0-24h after surgeries

Secondary Outcome Measure Information:

Title

VAS rating of sedation

Time Frame

0h to 24h after the end of the operation

Title

Overall VAS rating of satisfaction with analgesia

Time Frame

24 h after operation

Title

Incidence of side effects

Time Frame

From the initiation of analgesia (0 h) to the end of the study (24 h postoperative)

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

XiaoFeng Shen, MD

Organizational Affiliation

Nanjing Medical University

Official's Role

Study Chair

Facility Information:

Facility Name

Nanjing Maternal and Child Care Hospital

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210004

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

18622068

Citation

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.

Results Reference

result

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Comparison of Pain Therapeutic Effects After Benign Mastectomy

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