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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Postoperative Pain
• Intervention / Treatment: Procedure: Ultrasound guided Erector Spinae Plane Block (ESPB)

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Turkey
  • Melikgazi
    • Kayseri, Melikgazi, Turkey
      • TC Erciyes University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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); 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographic Data	Age, sex, medical history, BMI, ASA (American Society of Anesthesiologists) status, Duration and type of surgery were recorded	First 24 hours after surgery
Blood Pressures	systolic, diastolic and mean arterial blood pressures as mmHg	during and first 24 hours after surgery
Heart Rate	Heart rate as beat per minute (BPM)	during and first 24 hours after surgery
incidence of adverse effects (like nausea and vomiting)	incidence of nausea and vomiting during the 24 hours postoperative period was recorded recorded at 5 times intervals ( 2, 4, 6, 12, 24 hours)	First 24 hours after surgery
Rescue analgesic requirement	number of request and dosages of non opioid analgesics used for VAS equal or greater than 5 or patient request.	First 24 hours after surgery

Collaborators and Investigators

• Sponsor: TC Erciyes University
• Investigators: Principal Investigator: ersin SÖNMEZ, Research Asisstant

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): March 3, 2021

Study Registration Dates

• First Submitted: August 11, 2020
• First Submitted That Met QC Criteria: August 12, 2020
• First Posted (Actual): August 13, 2020

Study Record Updates

• Last Update Posted (Actual): March 11, 2021
• Last Update Submitted That Met QC Criteria: March 9, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: analgesic; breast cancer; surgery; postoperative pain; Erector spinae plane block
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Neoplasms; Neoplasms by Site; Postoperative Complications; Pain; Neurologic Manifestations; Breast Diseases; Pain, Postoperative; Breast Neoplasms
• Other Study ID Numbers: 2020/134

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No