Ultrasound-Guided Serratus Anterior Plane Block in Pneumothorax Surgery

Postoperative Pain Clinical Trial

Official title:

Comparison of the Analgesic Effect Between Ultrasound-Guided Serratus Anterior Plane Block and Intercostal Nerve Block After Single Port Video-Assisted Thoracoscopic Surgery in Primary Spontaneous Pneumothorax

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04191850
• Other study ID #: 2017-12-012-001
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: January 31, 2020

Study information

• Verified date: December 2019
• Source: Kyungpook National University Hospital
• Contact: Jimin Heo
• Phone: +82-53-420-5430
• Email: knuhmrc[@]knu.ac.kr
• Is FDA regulated: No
• 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 single port video-assisted thoracoscopic surgery with primary spontaneous pneumothorax.

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. Furthermore, single-port thoracoscopic surgery, which reduces the number of surgical incision, is increasingly carried out by many institutions world widely.

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 single port video-assisted thoracoscopic surgeries. 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 primary spontaneous pneumothorax patients who have undergone single port video-assisted thoracoscopic wedge resection. This prospective study will discover the efficacy and differences between two methods.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: January 31, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

1. American Society of Anesthesiologists (ASA) physical status 1 or 2

2. primary spontaneous pneumothorax

3. elective single port video-assisted thoracoscopic wedge resection of the lung.

Exclusion Criteria:

1. secondary spontaneous pneumothorax

2. reoperation in ipsilateral thorax

3. a history of drug allergy for analgesics

4. participants who have difficulty understanding the study protocol

5. refusal of participants

Related Conditions & MeSH terms

• Analgesia
• Pneumothorax
• Postoperative Pain

Intervention

Procedure:
• Single Port Video-Assisted Thoracoscopic Surgery
Single Port Video-Assisted Thoracoscopic wedge resection was performed for primary spontaneous pneumothorax.

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)	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)	After removal of chest tube
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 year
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