Comparison of Erector Spina Plane Block and Thoracic Epidural Block

NCT ID: NCT04702061

Last Updated: 2021-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-11
• Study Completion Date: 2021-03-31

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.

Conditions

Breast Neoplasms; Pain, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Group E

Patients who receive general anesthesia after erector spina plane block

Group Type: ACTIVE_COMPARATOR

Erector spina plane block before general anaesthesia

Intervention Type: OTHER

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.

Group T

Patients who receive general anesthesia after thoracic epidural block

Group Type: ACTIVE_COMPARATOR

Thoracic epidural block before general anaesthesia

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Inonu University

OTHER

Sponsor Role: lead

Responsible Party

Gulay ERDOGAN KAYHAN

Professor, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gulay ERDOGAN KAYHAN, MD

Role: PRINCIPAL_INVESTIGATOR

Professor Doctor

Locations

Eskisehir Osmangazi University

Eskişehir, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Esogu Anesthesia

Identifier Type: -

Identifier Source: org_study_id