Comparison of Erector Spina Plane Block and Thoracic Epidural Block

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04702061
• Other study ID #: Esogu Anesthesia
• Status: Completed
• Phase: N/A
• Start date: January 11, 2021
• Est. completion date: March 31, 2021

Study information

• Verified date: April 2021
• Source: Inonu University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 31, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Breast Neoplasms
• Pain, Postoperative

Intervention

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.
• 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.

Locations

Country	Name	City	State
Turkey	Eskisehir Osmangazi University	Eskisehir

Sponsors (1)

Lead Sponsor	Collaborator
Inonu University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sympathetic block level evaluation with skin conductivity	Skin conductivity will be measured by galvanic skin response (GSR)	45 minutes after block administration
Primary	Sympathetic block level evaluation with skin temperature	Skin temperature of bilateral thorax will be measured	45 minutes after block administration
Primary	Sympathetic block level evaluation with hot cold test	Hot cold test of bilateral thorax will be measured	45 minutes after block administration
Primary	Sympathetic block level evaluation by hemodynamic data	Peri-operative heart rate and mean arterial pressure will be recorded	45 minutes after block administration
Primary	Sensorial block level evaluation	By pin-prick test	45 minutes after block administration
Secondary	intraoperative hemodynamic data	Heart rate and mean arterial pressure	During the operation
Secondary	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
Secondary	Rescue analgesics consumption	Amount of remifentanil (microgram)	During the operation and 24 hours after operation
Secondary	Rescue analgesics consumption	Amount of tramadol (milligram)	24 hours after operation