Using Bupivacaine Locally in the Mastectomy Drains to Control Postoperative Pain

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

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

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Breast Cancer
• Intervention / Treatment: Drug: 40ml of 0.25% bupivacaine; Drug: 40ml of 0.9% normal saline

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 Type: Interventional
• Enrollment (Actual): 168
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt
    • Faculty of Medicine, Main Univeristy Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 28 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: 40ml of 0.25% bupivacaine
Placebo Comparator: 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)	Drug: 40ml of 0.9% normal saline

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Alexandria University
• Investigators: Principal Investigator: Mahmoud A Alhussini, md, Faculty of Medicine , Univeristy of Alexandria

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): November 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: January 6, 2019
• First Submitted That Met QC Criteria: January 8, 2019
• First Posted (Actual): January 10, 2019

Study Record Updates

• Last Update Posted (Actual): January 10, 2019
• Last Update Submitted That Met QC Criteria: January 8, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: bupivacaine; Post-mastectomy acute pain; Wound instillation
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: malhussini001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No