Analgesic Efficacy of Erector Spinae Plane Block After Breast Cancer Surgery

Breast Cancer Clinical Trial

Official title:

Analgesic Efficacy of Erector Spinae Plane Block After Breast Cancer Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04512391
• Other study ID #: 2020/134
• Status: Completed
• Start date: September 1, 2018
• Est. completion date: March 3, 2021

Study information

• Verified date: March 2021
• Source: TC Erciyes University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 3, 2021
• Est. primary completion date: December 31, 2019
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Pain, Postoperative
• Postoperative Pain

Intervention

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.

Locations

Country	Name	City	State
Turkey	TC erciyes university	Kayseri	Melikgazi

Sponsors (1)

Lead Sponsor	Collaborator
TC Erciyes University

Country where clinical trial is conducted

Turkey, 

References & 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. — View Citation

Gürkan Y, Aksu C, Kus A, Yörükoglu UH, Kiliç 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Blood Pressures	systolic, diastolic and mean arterial blood pressures as mmHg	during and first 24 hours after surgery
Secondary	Heart Rate	Heart rate as beat per minute (BPM)	during and first 24 hours after surgery
Secondary	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
Secondary	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