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Using Bupivacaine Locally in the Mastectomy Drains to Control Postoperative Pain

Primary Purpose

Pain, Postoperative, Breast Cancer

Status

Completed

Phase

Phase 4

Locations

Egypt

Study Type

Interventional

Intervention

40ml of 0.25% bupivacaine

40ml of 0.9% normal saline

About this trial

This is an interventional supportive care trial for Pain, Postoperative focused on measuring bupivacaine, Post-mastectomy acute pain, Wound instillation

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Faculty of Medicine, Main Univeristy Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Bupivacaine

Placebo

Arm 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.

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)

Outcomes

Primary Outcome Measures

Visual analogue pain score

The intensity of pain will be assessed by the VAS score

Number of demands for analgesic

How many times the patient will require analgesics

Timing of first demand for analgesic

Time lapse between recovery from surgery and first demand for analgesic

Secondary Outcome Measures

Full Information

NCT ID

NCT03799757

First Posted

January 6, 2019

Last Updated

January 8, 2019

Sponsor

Alexandria University

1. Study Identification

Unique Protocol Identification Number

NCT03799757

Brief Title

Using Bupivacaine Locally in the Mastectomy Drains to Control Postoperative Pain

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Completed

Study Start Date

January 2016 (Actual)

Primary Completion Date

November 2018 (Actual)

Study Completion Date

December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain, Postoperative, Breast Cancer

Keywords

bupivacaine, Post-mastectomy acute pain, Wound instillation

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

168 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Bupivacaine

Arm Type

Active Comparator

Arm 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.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm 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)

Intervention Type

Drug

Intervention Name(s)

40ml of 0.25% bupivacaine

Intervention Type

Drug

Intervention Name(s)

40ml of 0.9% normal saline

Primary Outcome Measure Information:

Title

Visual analogue pain score

Description

The intensity of pain will be assessed by the VAS score

Time Frame

first 24 hours

Title

Number of demands for analgesic

Description

How many times the patient will require analgesics

Time Frame

First 24 hours

Title

Timing of first demand for analgesic

Description

Time lapse between recovery from surgery and first demand for analgesic

Time Frame

First 24 hours

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

only females with breast cancer who were subjected to mastectomy with axillary nodal dissection were enrolled

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: female patients with unilateral breast cancer candidates for total mastectomy and axillary dissection Exclusion Criteria: Male patients Bilateral breast cancer. Patients with a history of a long duration of NSAID intake or other painkillers, drug abuse Patients with chest wall pain like Tietze syndrome, history of angina pectoris or recent HZV infection. Patients with known psychological or mental problems. Patients who were not exposed to axillary dissection

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mahmoud A Alhussini, md

Organizational Affiliation

faculty of medicine , univeristy of alexandria

Official's Role

Principal Investigator

Facility Information:

Facility Name

Faculty of Medicine, Main Univeristy Hospital

City

Alexandria

Country

Egypt

12. IPD Sharing Statement

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Using Bupivacaine Locally in the Mastectomy Drains to Control Postoperative Pain

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