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Comparison of Pain Therapeutic Effects After Benign Mastectomy

NCT00519246 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 2000

Last updated 2009-03-31

No results posted yet for this study

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.

Conditions

  • Pain, Postoperative
  • Mastectomy

Interventions

DRUG

Saline

Saline 5 ml administrated intravenously

DRUG

Opioid

Butorphanol tartrate 1 mg i.v.

DRUG

Opioid

Butorphanol Tartrate 2 mg i.v.

DRUG

NSAID

Flurbiprofen Axetil 50 mg i.v.

DRUG

NSAID

Flurbiprofen Axetil 100 mg i.v.

DRUG

Opioid

Tramadol Hydrochloride 10 mg i.v.

DRUG

Opioid

Tramadol Hydrochloride 20 mg i.v.

Sponsors & Collaborators

  • Nanjing Medical University

    lead OTHER

Principal Investigators

  • XiaoFeng Shen, MD · Nanjing Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2007-12-31
Completion
2007-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00519246 on ClinicalTrials.gov