Comparison of Erector Spina Plane Block and Thoracic Epidural Block

NCT04702061 | Completed

• 1 other identifier: Esogu Anesthesia
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasms; Pain, Postoperative

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (4)

• intraoperative hemodynamic data

  During the operation

• Postoperative pain scores

  24 hours after operation

• Rescue analgesics consumption

  During the operation and 24 hours after operation

• Rescue analgesics consumption

  24 hours after operation

Study Arms (2)

Group E

ACTIVE COMPARATOR

Patients who receive general anesthesia after erector spina plane block

Other: Erector spina plane block before general anaesthesia

Group T

ACTIVE COMPARATOR

Patients who receive general anesthesia after thoracic epidural block

Other: Thoracic epidural block before general anaesthesia

Interventions

Erector spina plane block before general anaesthesia 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 E

Thoracic epidural block before general anaesthesia 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.

Group T

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Inonu University: lead

Study Sites (1)

Eskisehir Osmangazi University

Eskişehir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Neoplasms; Pain, Postoperative

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Gulay ERDOGAN KAYHAN, MD

  Professor Doctor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD

Study Record Dates

• First Submitted: December 24, 2020
• First Posted: January 8, 2021
• Study Start: January 11, 2021
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2021
• Last Updated: April 20, 2021

Record last verified: 2021-04

Locations

TU (1)