Perioperative Erector Spinae Plane Block in Thoracoscopic Surgery

Sponsor

Kangbuk Samsung Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT03777592

Collaborator

(none)

Enrollment

Location

Arms

22.6

Anticipated Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The erector spinae plane block (ESPB) is a novel myofascial plane block. The ESPB is targeted at anterior surface of the erector spinae plane, which is oriented cephalocaudally to the spinal transverse process. Local anaesthetic injected in this plane can block the dorsal rami and ventral rami and intercostal nerves. The aim of this study was to evaluate the effect of ESPB on postoperative pain in thoracic surgery.

Condition or Disease	Intervention/Treatment	Phase
Pain, Postoperative Regional Block	Procedure: erector spinae plane block	N/A

Detailed Description

The erector spinae plane block (ESPB) is a newly defined regional anesthesia technique for thoracic analgesia. The blocks were performed at the T5 level of the spine using an in-plane approach.Previous studies were not designed as randomized controlled trial. In this study, the efficacy of ESPB is to confirm with randomized controlled trial design. ESPB will be performed in video assisted thoracoscopy preoperatively. After the surgery, the efficacy of ESPB will be assessed.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

54 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Correlation Between Perioperative Erector Spinae Plane Block and Postoperative Pain in Thoracoscopic Surgery

Actual Study Start Date :

Dec 15, 2018

Anticipated Primary Completion Date :

Jun 1, 2020

Anticipated Study Completion Date :

Nov 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: ESPB with local agent ESPB will be performed using 20ml of 0.5% ropivacaine.	Procedure: erector spinae plane block local anesthetic or saline is administered in to the interfascial plane between the transverse process of the vertebra and the erector spinae muscles, spreading to multiple paravertebral spaces
Sham Comparator: ESPB with saline ESPB will be performed using 20ml of saline.	Procedure: erector spinae plane block local anesthetic or saline is administered in to the interfascial plane between the transverse process of the vertebra and the erector spinae muscles, spreading to multiple paravertebral spaces

Arm

Intervention/Treatment

Active Comparator: ESPB with local agent

ESPB will be performed using 20ml of 0.5% ropivacaine.

Procedure: erector spinae plane block

local anesthetic or saline is administered in to the interfascial plane between the transverse process of the vertebra and the erector spinae muscles, spreading to multiple paravertebral spaces

Sham Comparator: ESPB with saline

ESPB will be performed using 20ml of saline.

Procedure: erector spinae plane block

local anesthetic or saline is administered in to the interfascial plane between the transverse process of the vertebra and the erector spinae muscles, spreading to multiple paravertebral spaces

Outcome Measures

Primary Outcome Measures

Pain scale [the first 5 min after arriving at the recovery room]
11-point numeric rating scale( (Scores from 0 to 10 are scored. The higher the score, the higher the degree of pain.The score is given in units of one point.)
Pain scale [20 min after arriving at the recovery room]
11-point numeric rating scale (Scores from 0 to 10 are scored. The higher the score, the higher the degree of pain.The score is given in units of one point.)

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

American Society of Anesthesiologists Patients with physical class 1, 2
Patients undergoing video assisted thoracoscopic surgery

Exclusion Criteria:

Patients who experienced side effects on local anesthetics
Patients with abnormal blood coagulation tests (INR> 1.5)
Pregnant or lactating patients

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	KangbukSamsung Hospital	Seoul		Korea, Republic of	03181

Sponsors and Collaborators

Kangbuk Samsung Hospital

Investigators

Principal Investigator: Sung Hyun Lee, MD, Kangbuk Samsung Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sung Hyun Lee, Assistant Professor, Kangbuk Samsung Hospital

ClinicalTrials.gov Identifier:

NCT03777592

Other Study ID Numbers:

2018-09-017-001

First Posted:

Dec 17, 2018

Last Update Posted:

Feb 28, 2019

Last Verified:

Feb 1, 2019

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:

Pain, Postoperative

Study Results

No Results Posted as of Feb 28, 2019