NCT00519246

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Feb 2007

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 21, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 22, 2007

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

March 31, 2009

Status Verified

March 1, 2009

Enrollment Period

10 months

First QC Date

August 21, 2007

Last Update Submit

March 30, 2009

Conditions

Pain, PostoperativeMastectomy

Keywords

Breast NeoplasmsNon-Steroidal Anti-Inflammatory AgentsAnalgesia

Outcome Measures

Primary Outcomes (1)

  • Visual analog scale (VAS) rating of pain

    0-24h after surgeries

Secondary Outcomes (3)

  • VAS rating of sedation

    0h to 24h after the end of the operation

  • Overall VAS rating of satisfaction with analgesia

    24 h after operation

  • Incidence of side effects

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

Study Arms (7)

I

PLACEBO COMPARATOR

No drug was delivered.

Drug: Saline

II

ACTIVE COMPARATOR

Butorphanol tartrate 1mg was given intravenously.

Drug: Opioid

III

ACTIVE COMPARATOR

Butorphanol tartrate 2 mg was given intravenously.

Drug: Opioid

IV

ACTIVE COMPARATOR

Flurbiprofen Axetil 50 mg was given intravenously.

Drug: NSAID

V

ACTIVE COMPARATOR

Flurbiprofen Axetil 100 mg was given intravenously.

Drug: NSAID

VI

ACTIVE COMPARATOR

Tramadol Hydrochloride 10 mg was given intravenously.

Drug: Opioid

VII

ACTIVE COMPARATOR

Tramadol Hydrochloride 20 mg was given intravenously.

Drug: Opioid

Interventions

SalineDRUG

Saline 5 ml administrated intravenously

Also known as: Physiological solution
I
OpioidDRUG

Butorphanol tartrate 1 mg i.v.

Also known as: NuoYang
II
NSAIDDRUG

Flurbiprofen Axetil 50 mg i.v.

Also known as: CaiFen
IV

Eligibility Criteria

Age18 Years - 64 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanjing Maternal and Child Care Hospital

Nanjing, Jiangsu, 210004, China

Location

Related Publications (1)

  • 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.

    PMID: 18622068RESULT

MeSH Terms

Conditions

Pain, PostoperativeBreast NeoplasmsAgnosia

Interventions

Sodium ChlorideAnalgesics, OpioidAnti-Inflammatory Agents, Non-SteroidalTramadol

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsNarcoticsCentral Nervous System DepressantsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesAnalgesicsSensory System AgentsPeripheral Nervous System AgentsCentral Nervous System AgentsTherapeutic UsesAnalgesics, Non-NarcoticAnti-Inflammatory AgentsAntirheumatic AgentsCyclohexanolsHexanolsFatty AlcoholsAlcoholsOrganic ChemicalsDimethylaminesMethylaminesAminesLipids

Study Officials

  • XiaoFeng Shen, MD

    Nanjing Medical University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 21, 2007

First Posted

August 22, 2007

Study Start

February 1, 2007

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

March 31, 2009

Record last verified: 2009-03

Locations

CN(1)