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Comparison of Erector Spina Plane Block and Thoracic Epidural Block

Primary Purpose

Breast Neoplasms, Pain, Postoperative

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Erector spina plane block before general anaesthesia

Thoracic epidural block before general anaesthesia

About this trial

This is an interventional treatment trial for Breast Neoplasms

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

Eskisehir Osmangazi University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Group E

Group T

Arm Description

Patients who receive general anesthesia after erector spina plane block

Patients who receive general anesthesia after thoracic epidural block

Outcomes

Primary Outcome Measures

Sympathetic block level evaluation with skin conductivity

Skin conductivity will be measured by galvanic skin response (GSR)

Sympathetic block level evaluation with skin temperature

Skin temperature of bilateral thorax will be measured

Sympathetic block level evaluation with hot cold test

Hot cold test of bilateral thorax will be measured

Sympathetic block level evaluation by hemodynamic data

Peri-operative heart rate and mean arterial pressure will be recorded

Sensorial block level evaluation

By pin-prick test

Secondary Outcome Measures

intraoperative hemodynamic data

Heart rate and mean arterial pressure

Postoperative pain scores

Pain score will be measured with visual analog scale (0-no pain; 10-worst pain) during movement and rest.

Rescue analgesics consumption

Amount of remifentanil (microgram)

Rescue analgesics consumption

Amount of tramadol (milligram)

Full Information

NCT ID

NCT04702061

First Posted

December 24, 2020

Last Updated

April 19, 2021

Sponsor

Inonu University

1. Study Identification

Unique Protocol Identification Number

NCT04702061

Brief Title

Comparison of Erector Spina Plane Block and Thoracic Epidural Block

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Completed

Study Start Date

January 11, 2021 (Actual)

Primary Completion Date

March 31, 2021 (Actual)

Study Completion Date

March 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Inonu University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Neoplasms, Pain, Postoperative

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group E

Arm Type

Active Comparator

Arm Description

Patients who receive general anesthesia after erector spina plane block

Arm Title

Group T

Arm Type

Active Comparator

Arm Description

Patients who receive general anesthesia after thoracic epidural block

Intervention Type

Other

Intervention Name(s)

Erector spina plane block before general anaesthesia

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Thoracic epidural block before general anaesthesia

Intervention Description

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.

Primary Outcome Measure Information:

Title

Sympathetic block level evaluation with skin conductivity

Description

Skin conductivity will be measured by galvanic skin response (GSR)

Time Frame