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Completed

NCT Number: NCT03341234

Superficial Serratus Plane Block for Modified Radical Mastectomy and Axillary Lymph Node Disection

Breast cancer is the most common type of cancer in women. Mastectomy and axillary lymph node disection are commonly performed as part of the cancer management. This surgery can cause significant postoperative pain. The serratus plane block (SPB) has been described for analgesia of the hemithorax and reported for many cases such as thoracoscopy, shoulder arthroscopy, breast surgery and axillary lymph node dissections. Serratus plane block may be a viable alternative to current regional anaesthetic techniques such as thoracic paravertebral and central neuraxial blockade.

The aim of this study is to determine effectiveness of ultrasound guided superficial serratus plane block in patients undergoing modified radical mastectomy and axillary lymph node dissection surgery.

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Key information

Conditions

Postoperative Analgesia Neurologic Manifestations Opioid Consumption Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Regional Training and Research Hospital

Erzurum, 25070, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • American Society of Anesthesiologist's physiologic state I-III patients undergoing Modified Radical Mastectomy and Axillary Lymph Node Disection

Exclusion criteria

  • chronic pain, bleeding disorders, renal or hepatic insufficiency,patients on chronic non-steroidal anti-inflammatory medications

Treatment and study plan

Bupivacaine

Drug

30 ml %0,25 bupivacaine

Saline

Drug

2 ml saline subcutaneously

Ultrasound

Device

Ultrasound guided block

Primary outcomes

  1. Opioid Consumption

    Time frame: First 24 hours total opioid consumption

    First 24 hours total fentanyl consumption with patient controlled analgesia

Secondary outcomes

  1. Visual analog pain score

    Time frame: postoperative first hour

    Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at first hour postoperatively.

  2. Visual analog pain score

    Time frame: postoperative second hour

    Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at second hour postoperatively.

  3. Visual analog pain score

    Time frame: postoperative 4th hour

    Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at 4th hour postoperatively.

  4. Visual analog pain score

    Time frame: postoperative 8th hour

    Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at 8th hour postoperatively.

  5. Visual analog pain score

    Time frame: postoperative 12th hour

    Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at 12th hour postoperatively.

  6. Visual analog pain score

    Time frame: postoperative 24th hour

    Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at 24th hour postoperatively.

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Registry information

Official study title

Analgesic Efficiency of Superficial Serratus Plane Block for Modified Radical Mastectomy and Axillary Lymph Node Disection: Randomized Controlled Study

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 14, 2017
Registry last updated
Nov 14, 2017

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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