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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04250272
Other study ID # 2019-07-008-002
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 16, 2019
Est. completion date February 29, 2020

Study information

Verified date January 2020
Source Kyungpook National University Hospital
Contact Jimin Heo
Phone +82-53-420-5430
Email knuhmrc@knu.ac.kr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A prospective randomized controlled study was undertaken to compare the postoperative analgesic effect between ultrasound-guided serratus anterior plane block and intercostal nerve block after video-assisted thoracoscopic lobectomy.


Description:

Post-thoracotomy pain is one of the most notorious postsurgical pains that one can experience. The pain is known to last for an extensive period of time with significantly high intensity.

In field of thoracic surgery, video-assisted thoracoscopic surgery has been played an important role in alleviating the postoperative pain. In field of anesthesiology, various attempts to alleviate post-thoracotomy pain have been tried along advancement of thoracic surgical techniques. It began with postoperative medication of non-steroid anti-inflammatory drugs, opioids and progressed into implementations such as local analgesia, thoracic epidural block, paravertebral block, intercostal nerve block, interpleural block and serratus anterior plane block.

Many analgesic methods have been applied to alleviate postoperative pain in patients who have undergone thoracoscopic surgeries. However, there are no prospective randomized controlled studies between intercostal nerve block and serratus anterior plane block in video-assisted thoracoscopic lobectomy. The main purpose of this study is to compare and analyze the effects between conventional intercostal nerve block and newly introduced serratus anterior plane block in lung cancer patients who have undergone video-assisted thoracoscopic lobectomy.

This prospective study will discover the efficacy and differences between two methods.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date February 29, 2020
Est. primary completion date January 31, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- lung cancer

- American Society of Anesthesiologists (ASA) I-III class

- Video-assisted thoracoscopic lobectomy

Exclusion Criteria:

- previous history of allergy to local anesthetics

- psychological disorder

- chronic analgesics or sedatives use

- coagulopathy

- The presence of systemic infection or local infection at injection site

- Pregnancy

Study Design


Intervention

Procedure:
Thoracoscopic lobectomy
Thoracoscopic lobectomy was performed for lung cancer

Locations

Country Name City State
Korea, Republic of Kyungpook national university hospital Daegu

Sponsors (1)

Lead Sponsor Collaborator
Kyungpook National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Postoperative pain: numeric rating scale Postoperative pain will be evaluated using a numeric rating scale (0 being no pain, 10 being worst pain imaginable) at postanesthesia care unit (PACU)
Primary Postoperative pain: numeric rating scale Postoperative pain will be evaluated using a numeric rating scale (0 being no pain, 10 being worst pain imaginable) 3 hours later operation
Primary Postoperative pain: numeric rating scale Postoperative pain will be evaluated using a numeric rating scale (0 being no pain, 10 being worst pain imaginable) 6 hours later operation
Primary Postoperative pain: numeric rating scale Postoperative pain will be evaluated using a numeric rating scale (0 being no pain, 10 being worst pain imaginable) 12 hours later operation
Primary Postoperative pain: numeric rating scale Postoperative pain will be evaluated using a numeric rating scale (0 being no pain, 10 being worst pain imaginable) 24 hours later operation
Secondary Number of analgesics consumption If the participant has additional analgesic requirement postoperatively, ketorolac 30mg will be injected intravenously when numeric rating scale score is measured as 4-5, and fentanyl 50# is injected when numeric rating scale score is over 6. through study completion, an average of 1 yea
Secondary Amount of analgesics consumption If the participant has additional analgesic requirement postoperatively, ketorolac 30mg will be injected intravenously when numeric rating scale score is measured as 4-5, and fentanyl 50# is injected when numeric rating scale score is over 6. : through study completion, an average of 1 year
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