Using Bupivacaine Locally in the Mastectomy Drains to Control Postoperative Pain

Breast Cancer Clinical Trial

Official title:

Role of Wound Installation With Bupivacaine Through Surgical Drains in Postoperative Analgesia in Modified Radical Mastectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03799757
• Other study ID #: malhussini001
• Status: Completed
• Phase: Phase 4
• Start date: January 2016
• Est. completion date: December 2018

Study information

• Verified date: January 2019
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: December 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Pain, Postoperative

Intervention

Drug:
• 40ml of 0.25% bupivacaine

• 40ml of 0.9% normal saline

Locations

Country	Name	City	State
Egypt	Faculty of Medicine, Main Univeristy Hospital	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

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