Comparison of Erector Spina Plane Block and Thoracic Epidural Block

Comparison of Erector Spina Plane Block and Thoracic Epidural Block in Breast Surgery

The aim of this randomised controlled and double-blind study, is to compare the effects of erector spinae plane (ESP) and thoracic epidural (TEA) blocks on peri-operative hemodynamics and analgesia in patients undergoing unilateral mastectomies due to malignancy.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Breast Neoplasms
• Intervention / Treatment: Other: Erector spina plane block before general anaesthesia; Other: Thoracic epidural block before general anaesthesia

Detailed Description

Patients will be randomised into two groups as Group E (those who received general anesthesia after the erector spina plan block) and Group T (those who received general anesthesia after thoracic epidural block).

After the block skin conductivity (galvanic skin response - GSR), body temperature changes, sympathetic and sensory block levels, peri-operative hemodynamic data, postoperative pain scores and analgesic consumption will be recorded.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Eskişehir, Turkey
    • Eskisehir Osmangazi University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• ASA(American Society of Anesthesiologist) physical classification I-III
• Patients undergoing unilateral mastectomies due to malignancy

Exclusion Criteria:

• Active infection at the intervention site
• History of coagulopathy or anticoagulant use (less time has passed before peripheral and central blocks)
• Major cardiac, pulmonary, renal and neurological diseases
• Autonomic neuropathy or use of drugs that affect autonomic function
• Patients with type 1 diabetes or insulin dependent type 2 diabetes over 10 years
• Allergic to local anesthetics;
• Patients who are uncooperative or have psychiatric problems
• Morbidly obese (body mass index > 35 kg/m2)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group E; Patients who receive general anesthesia after erector spina plane block	Other: Erector spina plane block before general anaesthesia; After skin infiltration with 2 ml of 2% lidocaine, an 18 G tuohy needle will be directed between the erector spina muscle and the transverse process of the T4 vertebra using the in-plane technique. The location of the needle will be confirmed by hydrodissection with saline after touching the transverse process. After the plan open, 5 ml of 2% lidocaine, 10 ml of 0.5% bupivacaine and 10 ml of saline, including hydrodissection, will be given in a total amount of 25 ml. Then a 20-G epidural catheter will be inserted 3-4 cm and fixed.
Active Comparator: Group T; Patients who receive general anesthesia after thoracic epidural block	Other: Thoracic epidural block before general anaesthesia; After skin infiltration with 2 ml of 2% lidocaine, an 18 G tuohy needle will be entered through the T4-5 interspinous space (median or paramedian approach). After reaching the thoracic epidural area by loss of resistance method, the epidural catheter will be advanced and fixed to remain 3-4 cm in the epidural area. Following the test dose (2 ml of 2% lidocaine), 3 ml of 2% lidocaine, 5 ml of 0.5% bupivacaine and 5 ml of saline will be administered intermittently in a total volume of 15 ml.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sympathetic block level evaluation with skin conductivity	Skin conductivity will be measured by galvanic skin response (GSR)	45 minutes after block administration
Sympathetic block level evaluation with skin temperature	Skin temperature of bilateral thorax will be measured	45 minutes after block administration
Sympathetic block level evaluation with hot cold test	Hot cold test of bilateral thorax will be measured	45 minutes after block administration
Sympathetic block level evaluation by hemodynamic data	Peri-operative heart rate and mean arterial pressure will be recorded	45 minutes after block administration
Sensorial block level evaluation	By pin-prick test	45 minutes after block administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
intraoperative hemodynamic data	Heart rate and mean arterial pressure	During the operation
Postoperative pain scores	Pain score will be measured with visual analog scale (0-no pain; 10-worst pain) during movement and rest.	24 hours after operation
Rescue analgesics consumption	Amount of remifentanil (microgram)	During the operation and 24 hours after operation
Rescue analgesics consumption	Amount of tramadol (milligram)	24 hours after operation

Collaborators and Investigators

• Sponsor: Inonu University
• Investigators: Principal Investigator: Gulay ERDOGAN KAYHAN, MD, Professor doctor

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2021
• Primary Completion (Actual): March 31, 2021
• Study Completion (Actual): March 31, 2021

Study Registration Dates

• First Submitted: December 24, 2020
• First Submitted That Met QC Criteria: January 7, 2021
• First Posted (Actual): January 8, 2021

Study Record Updates

• Last Update Posted (Actual): April 20, 2021
• Last Update Submitted That Met QC Criteria: April 19, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Neoplasms; Neoplasms by Site; Postoperative Complications; Pain; Neurologic Manifestations; Breast Diseases; Pain, Postoperative; Breast Neoplasms; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: Esogu Anesthesia

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No