Sympatholytic Effect of Thoracic ESP

Sponsor

Keimyung University Dongsan Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT05723393

Collaborator

(none)

Enrollment

Location

Arms

9.5

Anticipated Duration (Months)

7.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary endpoint of this study was to identify if erector spinae plane bloock (ESPB) demonstrates any sympatholytic effect.

The secondary endpoint of this study was to compare the sympatholytic effect of ESPB bewteen 10 ml and 20 ml ESPBs.

Condition or Disease	Intervention/Treatment	Phase
Pain, Chronic	Procedure: Erector spinae plane block	N/A

Detailed Description

The erector spinae plane block (ESPB) is a less invasive, safer, and technically easy alternative procedure to conventional neuraxial anesthetic techniques. In contrast to common neuraxial techniques such as paravertebral and epidural injections, the ESPB targets an interfascial plane which is far from the spinal cord, root, and pleura. First applied to thoracic neuropathic pain, currently ESPB is being applied to postoperative pain control and includes variable clinical situations. In the abdomen and thoracic wall, thoracic ESPB can be applied for pain control after cardiac surgery, video-assisted thoracic surgery, laparoscopic cholecystectomy, and thoracotomy. Recently, favorable postoperative pain control after lumbar spinal or lower limb surgeries has been reported with lumbar ESPB. In addition, ESPB has also been used for chronic pain conditions in the upper and lower extremities. The perfusion index (PI) is a numerical value for the ratio between pulsatile and non-pulsatile blood flow measured by a special pulse oximeter. Although the special probe for PI measurement is relatively more expensive compared with ordinary pulse oximetery probes, its benefit as a marker of peripheral perfusion and as an idex for sympathetic stimulation have increased its use progressively.

ESPB can achieve analgesic effect by blocking the ventral and doramal ramus and possibly by diffusion into paravertebral space. In constrast to lumar region, thoracic paravertebral space is very close to the sympathetic chain. Therefore, sympatholytic effect might be achieved by thoracic ESPB. No previous study has demonstrated the sympatholytic effect of ESPB.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Comparison of Sympatholytic Effect of Thoracic ESP Using Two Volumes Local Anesthetics

Actual Study Start Date :

Feb 13, 2023

Anticipated Primary Completion Date :

Nov 30, 2023

Anticipated Study Completion Date :

Nov 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 10 ml T2 ESPB group T2 ESPB group where ESPB is performed at T2 with local anesthetics 10ml	Procedure: Erector spinae plane block fascial plane injection guided by ultrasound
Active Comparator: 20 ml ESPB group T2 ESPB group where ESPB is performed at T2 with local anesthetics 20ml	Procedure: Erector spinae plane block fascial plane injection guided by ultrasound

Arm

Intervention/Treatment

Active Comparator: 10 ml T2 ESPB group

T2 ESPB group where ESPB is performed at T2 with local anesthetics 10ml

Procedure: Erector spinae plane block

fascial plane injection guided by ultrasound

Active Comparator: 20 ml ESPB group

T2 ESPB group where ESPB is performed at T2 with local anesthetics 20ml

Procedure: Erector spinae plane block

fascial plane injection guided by ultrasound

Outcome Measures

Primary Outcome Measures

Perfusion index changes among 4 times period [baseline, 10minutes after ESPB, 20 minutes after ESPB, 30 minutes after ESPB]
Perfusion index changes after T2 ESPB among 4 times period
Numerical rating scale changes among 3 times period [baseline, 30 minutes after ESPB, 2 weeks after ESPB]
Numerical rating scale changes among 3 times period
Perfusion index ratio at 10 minutes [baseline, 10minutes after ESPB]
Perfusion index ratio at 10 minutes

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Complex regional pain syndrome
Post-thoracotomy pain syndrome
Cervical foraminal stenosis
Cervical disc herniation
Herpes zoster

Exclusion Criteria:

Pregnacy
Coagulation abormality
Previous spine surgery
Allergy to local anesthetics

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ji Hoon Park	Daegu		Korea, Republic of	42601

Sponsors and Collaborators

Keimyung University Dongsan Medical Center

Investigators

Principal Investigator: Ji H Hong, Keimyung University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ji Hee Hong, Professor, Keimyung University Dongsan Medical Center

ClinicalTrials.gov Identifier:

NCT05723393

Other Study ID Numbers:

2023-01-025-01

First Posted:

Feb 10, 2023

Last Update Posted:

Feb 15, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Chronic Pain

Study Results

No Results Posted as of Feb 15, 2023