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Completed

NCT Number: NCT03799757

Using Bupivacaine Locally in the Mastectomy Drains to Control Postoperative Pain

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

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Key information

Conditions

Pain, Postoperative Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

30 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Faculty of Medicine, Main Univeristy Hospital

Alexandria, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

40ml of 0.25% bupivacaine

Drug

40ml of 0.9% normal saline

Drug

Primary outcomes

  1. Visual analogue pain score

    Time frame: first 24 hours

    The intensity of pain will be assessed by the VAS score

  2. Number of demands for analgesic

    Time frame: First 24 hours

    How many times the patient will require analgesics

  3. Timing of first demand for analgesic

    Time frame: First 24 hours

    Time lapse between recovery from surgery and first demand for analgesic

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jan 10, 2019
Registry last updated
Jan 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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