Comparison of Pain Therapeutic Effects After Benign Mastectomy

Phase 4

Completed

• Conditions: Pain, Postoperative; Mastectomy
• Interventions: Drug: Saline; Drug: Opioid; Drug: NSAID

• Registration Number: NCT00519246
• Lead Sponsor: Nanjing Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02
• Study First Submitted: 2007-08-21
• Study First Submitted QC: 2007-08-21
• Study First Posted: 2007-08-22
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-30
• Last Update Posted: 2009-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 2000

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
I	Saline	No drug was delivered.
II	Opioid	Butorphanol tartrate 1mg was given intravenously.
III	Opioid	Butorphanol tartrate 2 mg was given intravenously.
IV	NSAID	Flurbiprofen Axetil 50 mg was given intravenously.
V	NSAID	Flurbiprofen Axetil 100 mg was given intravenously.
VI	Opioid	Tramadol Hydrochloride 10 mg was given intravenously.
VII	Opioid	Tramadol Hydrochloride 20 mg was given intravenously.

Primary Outcome Measures

Name	Time	Method
Visual analog scale (VAS) rating of pain	0-24h after surgeries

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Nanjing Maternal and Child Care Hospital; 🇨🇳 Nanjing, Jiangsu, China