Analgesic Efficacy of Erector Spinae Plane Block After Breast Cancer Surgery

NCT04512391 | Completed

• 1 other identifier: 2020/134
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Pain; Breast Cancer

Keywords

Erector spinae plane block; breast cancer; surgery; postoperative pain; analgesic

Outcome Measures

Primary Outcomes (2)

• Opioid Consumption

  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).

  First 24 hours after surgery

• Verbal Analog Pain Scores on rest and movement

  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.

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

Secondary Outcomes (5)

• Demographic Data

  First 24 hours after surgery

• Blood Pressures

  during and first 24 hours after surgery

• Heart Rate

  during and first 24 hours after surgery

• incidence of adverse effects (like nausea and vomiting)

  First 24 hours after surgery

• Rescue analgesic requirement

  First 24 hours after surgery

Study Arms (2)

Erector Spinae

patients who are administered ultrasound guided ESPB at T4 vertebrae level with long acting local anesthetic (%0,25 bupivacaine) and followed up with patient controlled analgesia device and all records about aforementioned data is completely available.

Procedure: Ultrasound guided Erector Spinae Plane Block (ESPB)

Control

patients who are not administered any regional analgesic technique and followed up with patient controlled analgesia device and all records about aforementioned data is completely available.

Interventions

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.

Erector Spinae

Eligibility Criteria

• Age: 18 Years - 65 Years
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

all patients undergoing breast surgery for breast cancer between September 2018 and December 2019 were included in our study.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

TC erciyes university

Kayseri, Melikgazi, Turkey (Türkiye)

Location

Related Publications (2)

• Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.

  PMID: 27501016 BACKGROUND

• Gurkan Y, Aksu C, Kus A, Yorukoglu UH, Kilic CT. Ultrasound guided erector spinae plane block reduces postoperative opioid consumption following breast surgery: A randomized controlled study. J Clin Anesth. 2018 Nov;50:65-68. doi: 10.1016/j.jclinane.2018.06.033. Epub 2018 Jul 2.

  PMID: 29980005 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• ersin SÖNMEZ

  Research Asisstant

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: August 11, 2020
• First Posted: August 13, 2020
• Study Start: September 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: March 3, 2021
• Last Updated: March 11, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)