Using Bupivacaine Locally in the Mastectomy Drains to Control Postoperative Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

168 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2018-12-31

Brief Summary

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in this study we are investigating the role of instillation of Bupivacaine through surgical drains at the end of mastectomy surgeries in controlling post operative pain and decreasing their pain killers requirement in the early postoperative period

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Detailed Description

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patients were enrolled into 2 groups. in one group the wound was installed by 40ml of 0.25% bupivacaine through axillary and chest wall drains (20ml in each drain). Then, the drains were clamped for 20 minutes.

in the other group the wound was installed by 40ml of 0.9% normal saline through axillary and chest wall drains (20ml in each drain). Then, the drains were clamped for 20 minutes. (placebo group) patients and health care providers were blinded as regard the study group patients enrolled in. Visual Analog Pain Scale which is a score for detection of how much the patient is annoyed from the pain- was assessed two and four hours post-operative then every four hours thereafter.

Conditions

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Pain, Postoperative Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Bupivacaine

The wound was installed by 40ml of 0.25% bupivacaine through axillary and chest wall drains (20ml in each drain). Then, the drains were clamped for 20 minutes.

Group Type ACTIVE_COMPARATOR

40ml of 0.25% bupivacaine

Intervention Type DRUG

Placebo

The wound was installed by 40ml of 0.9% normal saline through axillary and chest wall drains (20ml in each drain). Then, the drains were clamped for 20 minutes. (placebo group)

Group Type PLACEBO_COMPARATOR

40ml of 0.9% normal saline

Intervention Type DRUG

Interventions

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40ml of 0.25% bupivacaine

Intervention Type DRUG

40ml of 0.9% normal saline

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

female patients with unilateral breast cancer candidates for total mastectomy and axillary dissection

Exclusion Criteria

1. Male patients
2. Bilateral breast cancer.
3. Patients with a history of a long duration of NSAID intake or other painkillers, drug abuse
4. Patients with chest wall pain like Tietze syndrome, history of angina pectoris or recent HZV infection.
5. Patients with known psychological or mental problems.
6. Patients who were not exposed to axillary dissection

Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No