Comparison of Pain Therapeutic Effects After Benign Mastectomy (COPTEAM)

Nanjing Medical University

Status and phase: Completed; Phase 4

Conditions: Mastectomy; Pain, Postoperative

Treatments: Drug: Opioid; Drug: Saline; Drug: NSAID

Study type: Interventional

Funder types: Other

Identifiers

NCT00519246

NMCH2007-241

NMU-2579-4FW

Details and patient eligibility

About

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.

Enrollment: 2,000 patients

Sex: Female

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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2,000 participants in 7 patient groups, including a placebo group

I

Placebo Comparator group

Description:

No drug was delivered.

Treatment:

Drug: Saline

II

Active Comparator group

Description:

Butorphanol tartrate 1mg was given intravenously.

Treatment:

Drug: Opioid

Drug: Opioid

Drug: Opioid

Drug: Opioid

III

Active Comparator group

Description:

Butorphanol tartrate 2 mg was given intravenously.

Treatment:

Drug: Opioid

Drug: Opioid

Drug: Opioid

Drug: Opioid

IV

Active Comparator group

Description:

Flurbiprofen Axetil 50 mg was given intravenously.

Treatment:

Drug: NSAID

Drug: NSAID

V

Active Comparator group

Description:

Flurbiprofen Axetil 100 mg was given intravenously.

Treatment:

Drug: NSAID

Drug: NSAID

VI

Active Comparator group

Description:

Tramadol Hydrochloride 10 mg was given intravenously.

Treatment:

Drug: Opioid

Drug: Opioid

Drug: Opioid

Drug: Opioid

VII

Active Comparator group

Description:

Tramadol Hydrochloride 20 mg was given intravenously.

Treatment:

Drug: Opioid

Drug: Opioid

Drug: Opioid

Drug: Opioid