Using Bupivacaine Locally in the Mastectomy Drains to Control Postoperative Pain

Alexandria University

Status and phase: Completed; Phase 4

Conditions: Breast Cancer; Pain, Postoperative

Treatments: Drug: 40ml of 0.25% bupivacaine; Drug: 40ml of 0.9% normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT03799757

malhussini001

Details and patient eligibility

About

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

Full description

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.

Enrollment: 168 patients

Sex: Female

Ages: 30 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

168 participants in 2 patient groups, including a placebo group

Bupivacaine

Active Comparator group

Description:

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.

Treatment:

Drug: 40ml of 0.25% bupivacaine

Placebo

Placebo Comparator group

Description:

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)

Treatment:

Drug: 40ml of 0.9% normal saline