Using Bupivacaine Locally in the Mastectomy Drains to Control Postoperative Pain

Phase 4

Completed

• Conditions: Pain, Postoperative; Breast Cancer
• Interventions: Drug: 40ml of 0.25% bupivacaine; Drug: 40ml of 0.9% normal saline

• Registration Number: NCT03799757
• Lead Sponsor: Alexandria University

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2016-01
• Primary Completion: 2018-11
• Study Completion: 2018-12
• Status Verified: 2019-01
• Study First Submitted: 2019-01-06
• Study First Submitted QC: 2019-01-08
• Last Update Submitted: 2019-01-08
• Study First Posted: 2019-01-10
• Last Update Posted: 2019-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 168

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bupivacaine	40ml of 0.25% 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.
Placebo	40ml of 0.9% normal saline	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)

Primary Outcome Measures

Name	Time	Method
Visual analogue pain score	first 24 hours	The intensity of pain will be assessed by the VAS score
Number of demands for analgesic	First 24 hours	How many times the patient will require analgesics
Timing of first demand for analgesic	First 24 hours	Time lapse between recovery from surgery and first demand for analgesic

Trial Locations

Locations (1)

Faculty of Medicine, Main Univeristy Hospital; 🇪🇬 Alexandria, Egypt