Ultrasound-Guided Serratus Anterior Plane Block in Pneumothorax Surgery

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

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.

Study Overview

• Status: Unknown
• Conditions: Pneumothorax; Postoperative Pain; Analgesia
• Intervention / Treatment: Procedure: Single Port Video-Assisted Thoracoscopic Surgery

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daegu, Korea, Republic of, 700-412
    • Recruiting
    • Kyungpook National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intercostal Nerve Block; Intercostal Nerve Block was performed just before closing the surgical incision while looking directly at the affected intercostal space. 10ml of 0.375% ropivacaine was delivered evenly at anterior and posterior intercostal spaces from the port site.	Procedure: Single Port Video-Assisted Thoracoscopic Surgery; Single Port Video-Assisted Thoracoscopic wedge resection was performed for primary spontaneous pneumothorax.
Experimental: Serratus Anterior Plane Block; Serratus Anterior Plane Block was performed just before the start of surgery after anesthetic induction through ultrasound-guidance. 20ml of 0.375% ropivacaine was slowly injected between the fascia of serratus anterior and latissimus dorsi near 5th rib.	Procedure: Single Port Video-Assisted Thoracoscopic Surgery; Single Port Video-Assisted Thoracoscopic wedge resection was performed for primary spontaneous pneumothorax.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Kyungpook National University Hospital
• Investigators: Principal Investigator: Saeyoung Saeyoung, Kyungpook National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2018
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): January 31, 2020

Study Registration Dates

• First Submitted: December 4, 2019
• First Submitted That Met QC Criteria: December 9, 2019
• First Posted (Actual): December 10, 2019

Study Record Updates

• Last Update Posted (Actual): December 10, 2019
• Last Update Submitted That Met QC Criteria: December 9, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Pleural Diseases; Pneumothorax
• Other Study ID Numbers: 2017-12-012-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No