Comparison of Pain Therapeutic Effects After Benign Mastectomy

Pain, Postoperative Clinical Trial

— COPTEAM  

Official title:

Clinical Comparison of Postoperative Pain Therapeutic Effects After Benign Mastectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00519246
• Other study ID #: NMU-2579-4FW
• Secondary ID: NMCH2007-241
• Status: Completed
• Phase: Phase 4
• First received: August 21, 2007
• Last updated: March 30, 2009
• Start date: February 2007
• Est. completion date: December 2007

Study information

• Verified date: March 2009
• Source: Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2000
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 64 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mastectomy
• Pain, Postoperative

Intervention

Drug:
• Saline
Saline 5 ml administrated intravenously
• Opioid
Butorphanol tartrate 1 mg i.v.
• Opioid
Butorphanol Tartrate 2 mg i.v.
• NSAID
Flurbiprofen Axetil 50 mg i.v.
• NSAID
Flurbiprofen Axetil 100 mg i.v.
• Opioid
Tramadol Hydrochloride 10 mg i.v.
• Opioid
Tramadol Hydrochloride 20 mg i.v.

Locations

Country	Name	City	State
China	Nanjing Maternal and Child Care Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing Medical University

Country where clinical trial is conducted

China, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analog scale (VAS) rating of pain		0-24h after surgeries	Yes
Secondary	VAS rating of sedation		0h to 24h after the end of the operation	Yes
Secondary	Overall VAS rating of satisfaction with analgesia		24 h after operation	Yes
Secondary	Incidence of side effects		From the initiation of analgesia (0 h) to the end of the study (24 h postoperative)	Yes