Comparison of Pain Therapeutic Effects After Benign Mastectomy

Study Overview
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Brief Summary
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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.

Official Title
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Clinical Comparison of Postoperative Pain Therapeutic Effects After Benign Mastectomy

Conditions
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Pain, Postoperative, Mastectomy

Intervention / Treatment
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* Drug: Saline
* Drug: Opioid
* Drug: Opioid
* Drug: NSAID
* Drug: NSAID
* Drug: Opioid
* Drug: Opioid


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: I<br>No drug was delivered. | Drug: Saline<br>* Saline 5 ml administrated intravenously<br>* Other names: Physiological solution;|
| Active Comparator: II<br>Butorphanol tartrate 1mg was given intravenously. | Drug: Opioid<br>* Butorphanol tartrate 1 mg i.v.<br>* Other names: NuoYang;|
| Active Comparator: III<br>Butorphanol tartrate 2 mg was given intravenously. | Drug: Opioid<br>* Butorphanol Tartrate 2 mg i.v.<br>* Other names: NuoYang;|
| Active Comparator: IV<br>Flurbiprofen Axetil 50 mg was given intravenously. | Drug: NSAID<br>* Flurbiprofen Axetil 50 mg i.v.<br>* Other names: CaiFen;|
| Active Comparator: V<br>Flurbiprofen Axetil 100 mg was given intravenously. | Drug: NSAID<br>* Flurbiprofen Axetil 100 mg i.v.<br>* Other names: CaiFen;|
| Active Comparator: VI<br>Tramadol Hydrochloride 10 mg was given intravenously. | Drug: Opioid<br>* Tramadol Hydrochloride 10 mg i.v.<br>* Other names: Trama;|
| Active Comparator: VII<br>Tramadol Hydrochloride 20 mg was given intravenously. | Drug: Opioid<br>* Tramadol Hydrochloride 20 mg i.v.<br>* Other names: Trama;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analog scale (VAS) rating of pain |  | 0-24h after surgeries | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Neoplasms, Non-Steroidal Anti-Inflammatory Agents, Analgesia