Comparison of Pain Therapeutic Effects After Benign Mastectomy - Full Text View

Sponsor:	Nanjing Medical University
Information provided by:	Nanjing Medical University
ClinicalTrials.gov Identifier:	NCT00519246

Purpose

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.

Condition	Intervention	Phase
Pain, Postoperative Mastectomy	Drug: Saline Drug: Opioid Drug: NSAID	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Clinical Comparison of Postoperative Pain Therapeutic Effects After Benign Mastectomy

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Mastectomy

U.S. FDA Resources

Further study details as provided by Nanjing Medical University:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Enrollment:	2000
Study Start Date:	February 2007
Study Completion Date:	December 2007
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
I: Placebo Comparator No drug was delivered.	Drug: Saline Saline 5 ml administrated intravenously
II: Active Comparator Butorphanol tartrate 1mg was given intravenously.	Drug: Opioid Butorphanol tartrate 1 mg i.v.
III: Active Comparator Butorphanol tartrate 2 mg was given intravenously.	Drug: Opioid Butorphanol Tartrate 2 mg i.v.
IV: Active Comparator Flurbiprofen Axetil 50 mg was given intravenously.	Drug: NSAID Flurbiprofen Axetil 50 mg i.v.
V: Active Comparator Flurbiprofen Axetil 100 mg was given intravenously.	Drug: NSAID Flurbiprofen Axetil 100 mg i.v.
VI: Active Comparator Tramadol Hydrochloride 10 mg was given intravenously.	Drug: Opioid Tramadol Hydrochloride 10 mg i.v.
VII: Active Comparator Tramadol Hydrochloride 20 mg was given intravenously.	Drug: Opioid Tramadol Hydrochloride 20 mg i.v.

Eligibility

Ages Eligible for Study:	18 Years to 64 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00519246

Locations

China, Jiangsu
Nanjing Maternal and Child Care Hospital
Nanjing, Jiangsu, China, 210004

Sponsors and Collaborators

Nanjing Medical University

Investigators

Study Chair:

XiaoFeng Shen, MD

Nanjing Medical University

More Information

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.

Responsible Party:	Nanjing Maternal and Child Health Hospital ( XiaoFeng Shen )
Study ID Numbers:	NMU-2579-4FW, NMCH2007-241
Study First Received:	August 21, 2007
Last Updated:	March 30, 2009
ClinicalTrials.gov Identifier:	NCT00519246 History of Changes
Health Authority:	China: Ministry of Health

Keywords provided by Nanjing Medical University:

Breast Neoplasms
Non-Steroidal Anti-Inflammatory Agents
Analgesia

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Pain
Pharmacologic Actions
Signs and Symptoms
Pathologic Processes
Postoperative Complications
Analgesics, Non-Narcotic

Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents
Pain, Postoperative
Analgesics, Opioid

ClinicalTrials.gov processed this record on February 08, 2010