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Completed

NCT Number: NCT04512391

Analgesic Efficacy of Erector Spinae Plane Block After Breast Cancer Surgery

Erector spinae plane block(ESPB), which is firstly used for thoracic neuropathic pain, is newly developed and highly promising fascial plane block for providing postoperative analgesia for a great deal of surgeries including breast surgery. The investigators aim to study efficacy of ESPB for patients who undergone breast cancer surgery and is expected to benefit from opioid-sparing effect of this technique.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

TC erciyes university

Kayseri, Melikgazi, Turkey (Türkiye)

About this study

This is a retrospective, single-center clinical trial to evaluate analgesic efficacy of Erector spinae plane block (ESPB) after breast cancer surgery. Participant's demographics and medical history, type and extent of surgery, systemic opioid and non-opioid analgesic consumptions, hemodynamic variables and adverse events during and first 24 hours after surgery. After operation, pain scores at first 24 hours, 1., 3., and 6. month will be obtanied from surgical ward and pain clinic registires. patient controlled analgesia device usage history will be obtained from device database at our clinic.

Who can participate

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

Inclusion criteria

  • ASA I-II patients undergoing breast surgery for breast cancer
  • Becoming available of complete records about study data

Exclusion criteria

  • ASA III-IV patients
  • missing records about study data

Treatment and study plan

Ultrasound guided Erector Spinae Plane Block (ESPB)

Procedure

Ultrasound guided ESPB is applied at T4 vertebrae level, 3 cm lateral to mid-line where transverse process lies. After identification of transverse process, needle is advanced in plane and real time visualisation on ultrasound screen. When bonny contact is encountered, normal saline is injected for verification of placement, then, 25 ml %0,25 bupivacaine is injected plane between transverse process and erector spinae muscles.

Primary outcomes

  1. Opioid Consumption

    Time frame: First 24 hours after surgery

    all patients were given 0.05 mg/kg morphine iv and 1 gr paracetamol 30 minutes before end of surgery and in the recovery room, a patient- controlled analgesia device containing morphine 0.5 mg/ml, set to deliver a 1mg bolus dose of morphine with an 10 min lockout time. Total morphine consumption during the 24 hours postoperative period will recorded at 5 times intervals ( 2, 4, 6, 12, 24 hours).

  2. Verbal Analog Pain Scores on rest and movement

    Time frame: First 24 hours after surgery, at 1., 3., 6. month

    A Research assistant, blinded to the group allocation, interviewed patients and collected data at 5 times intervals ( 2, 4, 6, 12, 24, hours) in the 24 hours postoperatively. Patients were asked to rate their pain using verbal analog scale, where 0= no pain and 10= worst pain possible.

Secondary outcomes

  1. Demographic Data

    Time frame: First 24 hours after surgery

    Age, sex, medical history, BMI, ASA (American Society of Anesthesiologists) status, Duration and type of surgery were recorded

  2. Blood Pressures

    Time frame: during and first 24 hours after surgery

    systolic, diastolic and mean arterial blood pressures as mmHg

  3. Heart Rate

    Time frame: during and first 24 hours after surgery

    Heart rate as beat per minute (BPM)

  4. incidence of adverse effects (like nausea and vomiting)

    Time frame: First 24 hours after surgery

    incidence of nausea and vomiting during the 24 hours postoperative period was recorded recorded at 5 times intervals ( 2, 4, 6, 12, 24 hours)

  5. Rescue analgesic requirement

    Time frame: First 24 hours after surgery

    number of request and dosages of non opioid analgesics used for VAS equal or greater than 5 or patient request.

Sponsors and collaborators

Lead sponsor

TC Erciyes University

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2021
First posted
Aug 13, 2020
Registry last updated
Mar 11, 2021

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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