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Comparison of Pain Therapeutic Effects After Benign Mastectomy

NCT ID: NCT00519246

Last Updated: 2009-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

2000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2007-12-31

Brief Summary

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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

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Conditions

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Pain, Postoperative Mastectomy

Keywords

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Breast Neoplasms Non-Steroidal Anti-Inflammatory Agents Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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I

No drug was delivered.

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

Saline 5 ml administrated intravenously

II

Butorphanol tartrate 1mg was given intravenously.

Group Type ACTIVE_COMPARATOR

Opioid

Intervention Type DRUG

Butorphanol tartrate 1 mg i.v.

III

Butorphanol tartrate 2 mg was given intravenously.

Group Type ACTIVE_COMPARATOR

Opioid

Intervention Type DRUG

Butorphanol Tartrate 2 mg i.v.

IV

Flurbiprofen Axetil 50 mg was given intravenously.

Group Type ACTIVE_COMPARATOR

NSAID

Intervention Type DRUG

Flurbiprofen Axetil 50 mg i.v.

V

Flurbiprofen Axetil 100 mg was given intravenously.

Group Type ACTIVE_COMPARATOR

NSAID

Intervention Type DRUG

Flurbiprofen Axetil 100 mg i.v.

VI

Tramadol Hydrochloride 10 mg was given intravenously.

Group Type ACTIVE_COMPARATOR

Opioid

Intervention Type DRUG

Tramadol Hydrochloride 10 mg i.v.

VII

Tramadol Hydrochloride 20 mg was given intravenously.

Group Type ACTIVE_COMPARATOR

Opioid

Intervention Type DRUG

Tramadol Hydrochloride 20 mg i.v.

Interventions

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Saline

Saline 5 ml administrated intravenously

Intervention Type DRUG

Opioid

Butorphanol tartrate 1 mg i.v.

Intervention Type DRUG

Opioid

Butorphanol Tartrate 2 mg i.v.

Intervention Type DRUG

NSAID

Flurbiprofen Axetil 50 mg i.v.

Intervention Type DRUG

NSAID

Flurbiprofen Axetil 100 mg i.v.

Intervention Type DRUG

Opioid

Tramadol Hydrochloride 10 mg i.v.

Intervention Type DRUG

Opioid

Tramadol Hydrochloride 20 mg i.v.

Intervention Type DRUG

Other Intervention Names

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Physiological solution NuoYang NuoYang CaiFen CaiFen Trama Trama

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Nanjing Maternal and Child Health Hospital

Principal Investigators

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XiaoFeng Shen, MD

Role: STUDY_CHAIR

Nanjing Medical University

Locations

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Nanjing Maternal and Child Care Hospital

Nanjing, Jiangsu, China

Site Status

Countries

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China

References

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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.

Reference Type RESULT
PMID: 18622068 (View on PubMed)

Other Identifiers

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NMCH2007-241

Identifier Type: -

Identifier Source: secondary_id

NMU-2579-4FW

Identifier Type: -

Identifier Source: org_study_id